0A4F4F9BD490A749D5437F821CF06DF1
Standards of GCP in Conducting CTs (2012)
http://www.almbih.gov.ba/_doc/regulative/Smjernice_dobre_klinicke_prakse-bo.pdf
http://leaux.net/URLS/ConvertAPI Text Files/4C33561765607205478531C35DA623A5.en.txt
Examining the file media/Synopses/4C33561765607205478531C35DA623A5.html:
This file was generated: 2020-07-14 06:55:35
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
...
Political / nomad
Searching for indicator nomads:
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p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
p.(None): experience to perform their tasks.
...
Political / political affiliation
Searching for indicator party:
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p.(None): test results. (see "ICH" Guidelines for the Structure and Content of the Clinical Report
p.(None): examination).
p.(None): 1.14. Comparative product
p.(None): Tested or marketed product (i.e. active control) or placebo to compare drug / medical
p.(None): the product being clinically tested.
p.(None): 1.15. Compliance with the adopted clinical trial plan
p.(None): Compliance with all clinical trial requirements, Good Clinical Practice and applicable legal requirements.
p.(None): 1.16. Confidentiality
p.(None): Preventing the disclosure of proprietary information owned by the sponsor or disclosing the identity of the respondents,
p.(None): except for authorized ones.
p.(None): 1.17. The contract
p.(None): A written, dated and signed contract between two or more parties involved in determining the assignments,
p.(None): delegation and allocation of tasks and responsibilities, and financial matters if necessary. The contract may be based on
p.(None): Protocol.
p.(None): 1.18. Coordination committee
p.(None): A sponsor-based committee to conduct a multicenter clinical trial in concert.
p.(None): 1.19. Researcher Coordinator
p.(None): Researcher responsible for coordinating researchers at different participating multicenter centers
p.(None): examination.
p.(None): 1.20. Contract Research Organization (CRO)
p.(None): A legal or natural person who contracts with a sponsor of a clinical trial based on which of the sponsors
p.(None): assumes all or part of the authorization in the clinical trial.
p.(None): 1.21. Direct access to data
p.(None): Permission to view, analyze, verify and transmit all data and reports relevant to clinical evaluation
p.(None): testing.
p.(None): Any party having direct access to the documentation (eg domestic or foreign authorities, monitors and
p.(None): auditors) is obliged to take all reasonable precautions within the applicable legal provisions in order to preserve
p.(None): the secrecy of the identity of the respondents and the data owned by the sponsor
p.(None): 1.22. Clinical trial documentation
p.(None): All data in any format (including written, electronic, magnetic and optical records and
p.(None): recordings, x-rays, electrocardiograms, etc.) describing or recording methods, and conducting and / or
p.(None): the results of the clinical trial, the factors affecting it, and the measures taken.
p.(None): 1.23. Basic documentation
p.(None): Documents that, individually or together, provide an assessment of the conduct of the clinical trial and the quality
p.(None): the data obtained (see 8. Basic documents for conducting the clinical trial).
p.(None): 1.24. Good clinical practice
p.(None): Good Clinical Practice (GCP) is an international ethical and scientific system
p.(None): the quality of planning, performing, recording, monitoring and reporting on clinical trial at
p.(None): people, which enables the credibility of the information obtained during the examination and protection of rights
p.(None): and the safety of the respondent in accordance with the Declaration of Helsinki on the Protection of Patients' Rights (u
p.(None): (hereinafter referred to as the Declaration of Helsinki).
p.(None): 1.25. Independent Data Monitoring Committee
p.(None): An independent data monitoring committee may establish a sponsor in order to conduct a periodic assessment of the clinical course
p.(None): tests, safety data and key performance conclusions, and which he recommends
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): The duties of sponsor - researcher are combined the duties of sponsor and researcher
p.(None): 1.55. Standard Operating Procedures ("SOPs")
p.(None): Detailed written instructions for achieving uniformity in performing all clinical procedures
p.(None): testing.
p.(None): 1.56. Podistraživač
p.(None): Each individual member of the clinical trial team is appointed and supervised by
p.(None): investigator at the test center to perform key activities in the clinical trial and / or for
p.(None): clinical trial decision making (eg associates, specialists, research associates).
p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.(None): correlation with pharmacological and toxicological findings from animal species experiments.
p.(None): (3) Toxicology
p.(None): The summary should describe the toxic effects from significant studies carried out on different animal species, namely
p.(None): that it contains the following:
p.(None): - single dose;
p.(None): - repeated dose;
p.(None): - carcinogenicity;
p.(None): - special tests (eg irritation and sensitization);
p.(None): - reproductive toxicology;
p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 65
p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
p.(None): metabolism, if necessary), as well as information on the dose dependence of the effect obtained from earlier studies
p.(None): tests in humans (healthy volunteers and / or patients). The significance of this data should be considered. Where it is
p.(None): completed multiple clinical trials, review summaries of safety findings and
p.(None): efficacy by indication or subgroup can give a clear view of the data. Together
p.(None): a tabular summary of adverse reactions to the product under study (for all indications tested) can be very significant.
p.(None): Significant differences in adverse reactions to the indications and subgroups of subjects should be considered.
p.(None): The booklet for the researcher should describe the possible risks and side effects of the drug on the basis
p.(None): previous experience with the product tested and related drugs. Warnings and specials should also be mentioned
p.(None): measures as an integral part of the application of the test product.
p.(None): (3) Experiences after placing the test product on the market The Brochure should indicate the countries where it is
p.(None): interrogated
p.(None): the product has been granted marketing authorization. A summary of all relevant information obtained from
p.(None): markets (e.g., formulations, dosage, routes of administration, adverse reactions). The Brochure should, too
...
Health / Drug Dependence
Searching for indicator dependence:
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p.(None): - carcinogenicity;
p.(None): - special tests (eg irritation and sensitization);
p.(None): - reproductive toxicology;
p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 65
p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
p.(None): metabolism, if necessary), as well as information on the dose dependence of the effect obtained from earlier studies
p.(None): tests in humans (healthy volunteers and / or patients). The significance of this data should be considered. Where it is
p.(None): completed multiple clinical trials, review summaries of safety findings and
p.(None): efficacy by indication or subgroup can give a clear view of the data. Together
p.(None): a tabular summary of adverse reactions to the product under study (for all indications tested) can be very significant.
p.(None): Significant differences in adverse reactions to the indications and subgroups of subjects should be considered.
p.(None): The booklet for the researcher should describe the possible risks and side effects of the drug on the basis
p.(None): previous experience with the product tested and related drugs. Warnings and specials should also be mentioned
p.(None): measures as an integral part of the application of the test product.
p.(None): (3) Experiences after placing the test product on the market The Brochure should indicate the countries where it is
p.(None): interrogated
p.(None): the product has been granted marketing authorization. A summary of all relevant information obtained from
p.(None): markets (e.g., formulations, dosage, routes of administration, adverse reactions). The Brochure should, too
p.(None): indicate the countries in which the product tested has not been approved, or is
p.(None): withdrawn from the market, ie his registration was revoked.
p.(None): 7.3.7. Data Summary and Researcher's Guide
p.(None): This chapter should include a comprehensive review of preclinical and clinical data and provide a summary
p.(None): different aspects of the tested product based on data from different sources. This is given to the researcher
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): by the competent authorities of those
p.(None): IDENTIFICATION IDENTIFICATION
p.(None): countries.
p.(None): CODE OF RESPONDENTS
p.(None): of all respondents who participated in the examination for the purpose of monitoring them. The list should be kept confidential at
p.(None): the agreed time period
p.(None): The guidelines have been developed taking into account the applicable principles of good clinical practice in the European Union, Japan and
p.(None): The United States, but also Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
p.(None): These guidelines should be followed when analyzing clinical trial data at the time of submission
p.(None): requests to the competent authorities.
p.(None): The principles set out in these Guidelines may also apply
p.(None): 8.4.4. WITNESS CERTIFICATE Document that X
p.(None): (where available)
p.(None): 8.4.5. FINAL
p.(None): is odit performed Document yes
p.(None): in other clinical trials that may affect safety
p.(None): X and respondent welfare.
p.(None): MONITOR REPORT are all activities in
p.(None): 1. DEFINITIONS
p.(None): ABOUT TESTING COMPLETION
p.(None): 8.4.6. THERAPY GROUPS AND DECISION DOCUMENTATION
p.(None): 8.4.7. FINAL REPORT OF THE RESEARCHER TO THE ETHICAL COMMITTEE AND / OR THE COMPETENT AUTHORITIES
p.(None): 8.4.8. CLINICAL TESTING FINAL REPORT
p.(None): 9. PUBLISHING
p.(None): examination completed, and copies of basic documents kept in appropriate records
p.(None): Returns to the sponsor to document any decryption procedures
p.(None): Document completion of testing
p.(None): Document test results and interpretation
p.(None): X
p.(None): X
p.(None): X X
p.(None): (if necessary)
p.(None): 1.1. Adverse drug reaction
p.(None): Any adverse and unintentionally induced drug reaction that may occur at a therapeutic dose, or
p.(None): administration of the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological
p.(None): function (see "ICH" Clinical Safety Information Management Guidelines: Definitions and Standards for Emergency
p.(None): reporting).
p.(None): The term & quot; drug reaction & quot; means that there is a cause and effect relationship between the drug and the undesired
p.(None): to act at least as a possibility, ie. that it cannot be ruled out.
p.(None): 1.2. Adverse event
p.(None): Any adverse medical event in a clinical trial in a patient or subject
p.(None): who has received a pharmaceutical product and for which there is no need for a cause and effect relationship with the administration of the product
p.(None): to be proved. An adverse event represents any adverse and adverse event (including
p.(None): deviation in laboratory findings), symptom or disease associated with the use of (investigated)
p.(None): product, whether or not it is the cause (see "ICH" Clinical Data Management Guidelines
p.(None): security:
p.(None): These Guidelines shall enter into force on the day of their adoption and shall be published in the Official Gazette of BiH.
p.(None): Chairman of the Expert Council
p.(None): Definitions and standards for emergency reporting).
p.(None): 1.3. Amendments to the Protocol
p.(None): Amendments to the Protocol or formal explanation of the Protocol.
p.(None): No. 10-07.2-1174-1 / 12
p.(None): February 27, 2012
p.(None): Cf. mr ph.
p.(None): Ivan Prlic, s. r.
p.(None): 1.4. Legislation in force (s)
p.(None): Law (s) and regulation (s) relating to the conduct of clinical trials of medicinal products / medical devices.
p.(None): 1.5. Approval (Refers to Ethics Committee)
p.(None): Pursuant to Article 47, paragraph (3) of the Law on Medicines and Medical Devices of Bosnia and Herzegovina
p.(None): (Official Gazette of BiH, No. 58/08), Expert Council of the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.(None): Herzegovina, at the 13th session held on 17.11.2011. at the proposal of the Director of the Agency for Medicinal Products and
p.(None): medical devices of Bosnia and Herzegovina, brings
...
p.(None): sponsor standard operating procedures (SOPs), Good Clinical Practice and applicable legal requirements.
p.(None): 1.7. Certificate of Completion
p.(None): A statement confirming that the odit was performed.
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 51
p.(None): 1.8. Departure report
p.(None): Auditor's written report on the results of the audit.
p.(None): 1.9. The documentation is gone
p.(None): Documentation allowing monitoring of the course of the clinical trial.
p.(None): 1.10. Clinical trial blindness / masking
p.(None): A process to ensure that one or more parties participating in a clinical trial do not have insight into
p.(None): the respondents' belonging to the treatment groups. A single blind examination means that the respondent,
p.(None): that is, respondents have no insight into belonging to treatment groups, and double-blind to insight into belonging
p.(None): The treatment groups do not have a respondent, ie respondents, a researcher, a monitor, and in some cases, an analyst
p.(None): data.
p.(None): 1.11. Test list
p.(None): Printed, optical or electronic document intended to record all data required by the Protocol
p.(None): a clinical trial reporting the sponsor to each subject.
p.(None): 1.12. Clinical trial
p.(None): Any human test intended to detect or confirm clinical, pharmacological and / or
p.(None): pharmacodynamic effects of the test product and / or adverse reaction identification and / or testing
p.(None): resorption, distribution, metabolism and excretion, with the aim of determining safety and / or efficacy
p.(None): of the tested product.
p.(None): 1.13. Clinical trial report
p.(None): Document a complete clinical trial of any therapeutic, prophylactic or diagnostic efficacy
p.(None): of the drug, which summarizes clinically and statistically significant data, findings and analyzes obtained
p.(None): test results. (see "ICH" Guidelines for the Structure and Content of the Clinical Report
p.(None): examination).
p.(None): 1.14. Comparative product
p.(None): Tested or marketed product (i.e. active control) or placebo to compare drug / medical
p.(None): the product being clinically tested.
p.(None): 1.15. Compliance with the adopted clinical trial plan
p.(None): Compliance with all clinical trial requirements, Good Clinical Practice and applicable legal requirements.
p.(None): 1.16. Confidentiality
p.(None): Preventing the disclosure of proprietary information owned by the sponsor or disclosing the identity of the respondents,
p.(None): except for authorized ones.
p.(None): 1.17. The contract
p.(None): A written, dated and signed contract between two or more parties involved in determining the assignments,
p.(None): delegation and allocation of tasks and responsibilities, and financial matters if necessary. The contract may be based on
p.(None): Protocol.
p.(None): 1.18. Coordination committee
p.(None): A sponsor-based committee to conduct a multicenter clinical trial in concert.
p.(None): 1.19. Researcher Coordinator
p.(None): Researcher responsible for coordinating researchers at different participating multicenter centers
p.(None): examination.
p.(None): 1.20. Contract Research Organization (CRO)
p.(None): A legal or natural person who contracts with a sponsor of a clinical trial based on which of the sponsors
p.(None): assumes all or part of the authorization in the clinical trial.
p.(None): 1.21. Direct access to data
p.(None): Permission to view, analyze, verify and transmit all data and reports relevant to clinical evaluation
p.(None): testing.
p.(None): Any party having direct access to the documentation (eg domestic or foreign authorities, monitors and
p.(None): auditors) is obliged to take all reasonable precautions within the applicable legal provisions in order to preserve
...
p.(None): all the quality requirements related to the test are met.
p.(None): 1.48. Randomization
p.(None): The process of randomly selecting (classifying) subjects into a therapeutic or control group, thereby reducing it
p.(None): researcher bias.
p.(None): 1.49. Competent authorities
p.(None): Bodies competent for the adoption of legislation. For the purposes of these guidelines, the term competent authorities includes bodies which
p.(None): have the regulatory power to legislate including review a submitted clinical
p.(None): documentation and inspection (see 1.29).
p.(None): 1.50. Serious adverse event or serious adverse reaction
p.(None): Any undesirable medical phenomenon related to the health of the subjects causing at any dose:
p.(None): - death,
p.(None): - Immediate threat to life,
p.(None): - requires or extends existing hospitalization,
p.(None): - permanent or significant disability or disability,
p.(None): - congenital anomalies, that is, a birth defect.
p.(None): 1.51. Original data
p.(None): Original medical records from original documents and certified copies of original clinical and laboratory records
p.(None): findings or other results of activities performed during the clinical trial that are required for
p.(None): evaluation of test results.
p.(None): The original information is contained in the original documentation (as originals or certified copies).
p.(None): 1.52. Original documentation
p.(None): Source documents, data and records (e.g., medical history, clinical and administrative records,
p.(None): laboratory findings, memos, subjects' diaries or test lists, drug dispensing records, recorded
p.(None): automated device data, copies and transcripts verified after authentication, negatives,
p.(None): microfilms and magnetic recordings, x-rays, pharmacy records, laboratories and
p.(None): medical-technical services involved in the clinical trial).
p.(None): 1.53. Sponsor
p.(None): Individual or legal entity responsible for initiating, conducting and / or financing a clinical
p.(None): testing.
p.(None): 1.54. Sponsor - Researcher
p.(None): An individual who initiates and conducts a clinical trial, alone or with others, and under whose immediate supervision
p.(None): the test product is prescribed, dispensed, or applied by the respondent. This one
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 53
p.(None): the term is restricted to natural persons (ie does not include legal persons such as corporations or agencies).
p.(None): The duties of sponsor - researcher are combined the duties of sponsor and researcher
p.(None): 1.55. Standard Operating Procedures ("SOPs")
p.(None): Detailed written instructions for achieving uniformity in performing all clinical procedures
p.(None): testing.
p.(None): 1.56. Podistraživač
p.(None): Each individual member of the clinical trial team is appointed and supervised by
p.(None): investigator at the test center to perform key activities in the clinical trial and / or for
p.(None): clinical trial decision making (eg associates, specialists, research associates).
p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
...
p.(None): direct access to all documents related to the examination.
p.(None): 4.10. Test progress reports
p.(None): 4.10.1. The researcher should submit a written summary of the examination status to the Ethics Committee once a year or
p.(None): more often, at the request of the Ethics Committee.
p.(None): 4.10.2. The researcher should promptly submit a written report to the sponsor, the Ethics Committee (see 3.3.8) and, where
p.(None): to the healthcare institution, on changes that significantly affect the conduct of the examination and / or
p.(None): increase the risk for respondents.
p.(None): 4.11. Security reporting
p.(None): 4.11.1. All serious adverse events in the clinical trial should be reported to the sponsor immediately,
p.(None): except those which are not stated in the Protocol or other document (eg the Researcher's Brochure)
p.(None): should be reported immediately. A detailed event report should be written immediately after the application. That report
p.(None): instead of the respondent's name, unique identification number and / or address, the respondent should be identified
p.(None): predominantly by the original code number assigned to the respondent. The researcher should also adhere to the applicable ones
p.(None): legal regulations concerning reporting to the competent authorities and the Ethics Committee on unexpected serious
p.(None): adverse reactions to the drug.
p.(None): 4.11.2. Adverse events and / or unusual laboratory findings identified by the Protocol as critical to
p.(None): the safety assessment should be reported to the sponsor in accordance with established reporting rules and timed
p.(None): the period specified by the sponsor in the Protocol.
p.(None): 4.11.3. When reporting a death, the investigator should provide everything to the sponsor and the Ethics Committee
p.(None): additional information requested (eg autopsy findings and final medical report).
p.(None): 4.12. Premature completion or delay of clinical trial
p.(None): If for any reason the test is terminated or postponed early, the investigator / institution shall do so
p.(None): inform the respondents immediately, ensure their proper treatment and follow-up, and inform the competent
p.(None): bodies in accordance with applicable legal regulations. Besides:
p.(None): 4.12.1. If the researcher interrupts or postpones the examination without the prior consent of the sponsor, he shall be obliged to do so
p.(None): inform the institution and the investigator / institution should immediately inform the sponsor and the Ethics Committee and
p.(None): provide them with a detailed written explanation of the interruption or adjournment.
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p.(None): Monday, March 12, 2012
p.(None): 4.12.2. If the sponsor interrupts or postpones the examination (see 5.21), the investigator should be informed immediately
p.(None): institution and the researcher / institution should immediately inform the Ethics Committee and provide them in writing
p.(None): explanation of interruption or delay.
...
p.(None): 5.2.4. Anything in these guidelines that applies to the sponsor applies to the contracting research organization in that sponsor
p.(None): the extent to which the contracting research organization has assumed obligations and functions from the sponsor in relation to
p.(None): by conducting a clinical trial.
p.(None): 5.3. Professional doctoral opinion
p.(None): Medical professionals with appropriate qualifications should be identified, which will always be easy
p.(None): available, to clarify medical issues and resolve test issues. If necessary,
p.(None): the sponsor may also appoint external consultants for this purpose.
p.(None): 5.4. Test plan
p.(None): 5.4.1. The sponsor should, as appropriate, hire qualified persons (eg biostatistical, clinical)
p.(None): pharmacologists and doctors) at all stages of testing, from the development of the Protocol and the test
p.(None): list, through analysis planning, to analyzing and preparing interim and final clinical reports
p.(None): testing.
p.(None): 5.4.2. Explanations regarding the Protocol and amendments to the Protocol are provided in Chapter 6, "ICH"
p.(None): Guidelines for the structure and content of clinical trial reports and other "ICH" guidelines
p.(None): related to test planning, protocol development and testing.
p.(None): 5.5. Test management, data handling and record keeping
p.(None): 5.5.1. The sponsor should appoint appropriately qualified staff to oversee the whole
p.(None): conducting tests, for handling data, for validating data, for conducting statistical analysis
p.(None): and preparing test reports.
p.(None): 5.5.2. The sponsor may set up independent monitoring committees to periodically evaluate progress
p.(None): clinical trial, including safety data and critical conclusions on drug efficacy, and for recommendation
p.(None): to the sponsor whether to continue, modify, or terminate the examination. An independent commission should have written documents
p.(None): standard operating procedures and to keep written records of all its meetings.
p.(None): 5.5.3. When the test uses electronic data management, that is, a remote electronic system, the sponsor
p.(None): should:
p.(None): a) ensure and document the compliance of the electronic data processing system with the requirements
p.(None): sponsors for completeness, accuracy, reliability and consistency of processing, ie. validation;
p.(None): b) maintain standard operating procedures for the use of these systems;
p.(None): c) Provide a system that enables the data to be modified in such a way that each change is recorded and
p.(None): that there is no possibility of deleting the entered data (ie maintaining the transparency of the test data);
p.(None): d) provide a security system that prevents unauthorized access to data;
p.(None): e) maintain a list of persons authorized to change the information (see 4.1.5 and 4.9.3);
p.(None): f) maintain adequate data protection;
p.(None): g) Preserve masking, if any (eg when entering and processing data).
p.(None): 5.5.4. If data is transformed during its processing, it should always be left behind
p.(None): ability to compare original data with transformed data.
p.(None): 5.5.5. Sponsor should use unambiguous code to identify respondents (see 1.58.)
p.(None): which allows identification of all reported data for each respondent.
p.(None): 5.5.6. The sponsor or other data owners should keep all their basic documents concerning the sponsor in the
p.(None): related to the trial (see 8. Basic documents for conducting the clinical trial).
p.(None): 5.5.7. These documents should be kept by the sponsor in accordance with the applicable laws of the countries in which they are located
p.(None): a product approved for placing on the market and / or in the countries where it intends to apply for it
p.(None): approval.
p.(None): 5.5.8. If the sponsor interrupts the clinical development of the product under study (ie for some or all indications, the route of administration
p.(None): or dosage form) should retain all of its basic documents for at least two years from its formal termination
p.(None): tests or in accordance with applicable legal regulations.
p.(None): 5.5.9. If the sponsor interrupts the clinical development of the product under investigation, everyone should be informed
p.(None): researchers / institutions and all competent authorities.
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p.(None): 5.5.10. Any transfer of ownership of the data should be reported to the appropriate authorities, in accordance with the applicable ones
p.(None): legal regulations.
p.(None): 5.5.11. The sponsor should keep the basic documents for at least two years after the last approval
p.(None): of the request for placing the drug on the market in the "ICH" countries of the region, that is, as long as there is a request that
p.(None): countries, or at least two years after the official discontinuation of testing. These documents
p.(None): should be kept for a longer period if required by applicable law or
p.(None): sponsor needs.
p.(None): 5.5.12. The sponsor should inform the researcher / institution in writing of the need for further safekeeping
p.(None): data relating to the examination as well as the termination of the need to store them.
p.(None): 5.6. Choice of researcher
p.(None): 5.6.1. The sponsor is responsible for selecting the researcher / institution. To properly conduct the tests for which it is
p.(None): selected, each researcher should be qualified with his or her knowledge and experience and should have appropriate
p.(None): opportunities (see 4.1, 4.2). The sponsor is responsible for forming a coordination committee
p.(None): examinations and / or the selection of coordinator-researchers required to organize multicenter trials.
p.(None): 5.6.2. Before concluding a test contract with the investigator / institution, the sponsor should
p.(None): provide the researcher / institution with the Protocol, an updated Researcher's Brochure and should be given sufficient time to
p.(None): study the Protocol and the documentation provided.
p.(None): 5.6.3. The sponsor should contract with the research-
p.(None): what / institution that:
p.(None): a) conduct the examination in accordance with Good Clinical Practice, applicable legal requirements
p.(None): (see 4.1.3) and the Examination Protocol approved by the sponsor and the Ethics Committee (see 4.5.1);
p.(None): b) comply with all data retention and reporting procedures;
p.(None): c) facilitate monitoring, auditing and inspection (see 4.1.4);
...
p.(None): regulations;
p.(None): c) a documented approval / positive opinion of the Ethics Committee and, if requested by the sponsor, a copy
p.(None): current Protocol, respondent's written consent form, and any other written notice
p.(None): intended for the respondents, their recruitment process, as well as documentation relating to compensation
p.(None): respondents and other documents requested by the Ethics Committee.
p.(None): 5.11.2. If the Ethics Committee requires its approval / positive opinion to modify any aspect of the examination
p.(None): such as amendments to the Protocol, respondent's written consent form, other written notices and / or
p.(None): other procedures intended for respondents, the sponsor must receive a copy from the researcher / institution
p.(None): amendments documents and date of approval / positive opinion of the Ethics Committee.
p.(None): 5.11.3. The sponsor should receive documentation and re-approval dates from the researcher / institution, respectively
p.(None): reassessments with a positive decision of the Ethics Committee as well as withdrawal or delay of approval / positive
p.(None): opinions.
p.(None): 5.12. Tested product data
p.(None): 5.12.1. When planning the test, the sponsor should provide sufficient safety information and
p.(None): drug efficacy from preclinical and / or clinical trials that justify human exposure
p.(None): the route of administration, the dosage, the length of the test and the appropriate population planned for the test.
p.(None): 5.12.2. When significant new information is available, the sponsor should update the Researcher Brochure (see
p.(None): 7.)
p.(None): 5.13. Production, packaging and labeling and coding of the product under test
p.(None): 5.13.1. The sponsor should ensure that the product under study (including, if necessary, a comparative drug)
p.(None): and placebo) characterized according to the stage of its development, to have been produced in accordance with the Good
p.(None): manufacturer's practice, and that it is encrypted and marked in a way that protects the blind process, if any. Besides,
p.(None): labeling should be in accordance with applicable legal regulations.
p.(None): 5.13.2. The sponsor should indicate appropriate storage conditions for the drug such as temperature, protection against influences
p.(None): light, storage time, drug reconstitution procedures and infusion agents as appropriate
p.(None): planned. The sponsor should inform all parties involved (i.e. monitors, researchers,
p.(None): pharmacists, warehouse managers).
p.(None): 5.13.3. The packaging of the test product should be such as to prevent its contamination and
p.(None): unacceptable degree of damage during transport and storage.
p.(None): 5.13.4. In blind tests, the encryption system of the product under test should also contain
p.(None): a mechanism that allows rapid identification of the drug in an emergency but which prevents it from becoming blind
p.(None): interrupts unnoticed.
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p.(None): Monday, March 12, 2012
p.(None): 5.13.5. If significant changes are made to the formulation of the test or comparative product during
p.(None): clinical development, results of any additional formulated drug study (e.g., stability, degree of availability,
p.(None): bioavailability) should be available before using the new formulation in a clinical trial to evaluate that
p.(None): whether such changes would significantly alter the pharmacokinetic profile of the product.
p.(None): 5.14. Delivering and handling the tested product
p.(None): 5.14.1. The sponsor is responsible for delivering the test product to the researcher / institution.
p.(None): 5.14.2. The sponsor does not need to provide the investigator / institution with the product under test until he has all the necessary information
p.(None): documentation (eg approval / positive opinion of the Ethics Committee and competent authorities).
p.(None): 5.14.3. The sponsor should ensure that the written procedures contain the instructions that the investigator / institution needs
p.(None): Observe during testing, handling and storage of the product under test and related documentation. These
p.(None): instructions should include proper and secure admission, handling, storage and dispensing of the subject
p.(None): product, downloading unused test product from respondent and returning it to the sponsor (ie
p.(None): another way to remove unused product if approved by the sponsor, in accordance with applicable law
p.(None): regulations).
p.(None): 5.14.4. The sponsor should:
p.(None): a) ensure timely delivery of the test product to the researcher;
p.(None): b) keep records of the transport, receipt, disposal, return and destruction of the product under test (see
p.(None): 8. Basic documents for conducting the clinical trial);
p.(None): c) provide for a system of return for the product under examination and for recording such a download (e.g.
p.(None): for recall of defective products, returns upon completion of tests, refunds after expiration
p.(None): duration);
p.(None): d) maintains a system for withdrawing unused test product and recording it
p.(None): withdrawals.
p.(None): 5.14.5. The sponsor should:
p.(None): a) take the necessary measures to ensure the stability of the product under test during the period of use;
p.(None): b) have sufficient quantities of the product under test for subsequent confirmation
p.(None): its specifications, if necessary, and keeps the documentation of the analysis and
p.(None): characteristics of the production batch sample. To the extent permitted by the stability of the drug, samples should be kept at or up to
p.(None): completing the analysis of the test results or by the deadline prescribed by applicable law, if required
p.(None): and a longer storage period.
p.(None): 5.15. Access to documentation
p.(None): 5.15.1. The sponsor should ensure that the Protocol or other written agreement states that
p.(None): the researcher / institution must allow direct access to the original data / documents
p.(None): for monitoring, audit, review by the Ethics Committee and inspection by the competent authorities.
p.(None): 5.15.2. The sponsor should determine that each respondent has given his / her written consent for direct access to his / her own
p.(None): original health data for monitoring, audit, review by the Ethics Committee and inspection by
p.(None): by the competent authorities.
p.(None): 5.16. Security information
p.(None): 5.16.1. The sponsor is responsible for the ongoing assessment of the safety of the product being tested.
p.(None): 5.16.2. The sponsor should promptly inform all researchers / institutions and competent authorities of
p.(None): knowledge that may adversely affect the safety of the respondent, the conduct of the examination, or the modification
p.(None): approval / positive opinion of the Ethics Committee.
p.(None): 5.17. Reporting adverse drug reactions
p.(None): 5.17.1. The sponsor should promptly inform all researchers / institutions, Ethics Committees (where applicable)
p.(None): necessary) and the competent authorities of any serious and unexpected adverse reactions to the drug.
p.(None): 5.17.2. These emergency reports should comply with applicable laws and "ICH"
p.(None): Clinical Safety Information Management Guidelines: Definitions and Standards for Urgent Reporting.
p.(None): 5.17.3. The sponsor should submit to the competent authorities all updated and periodic safety reports,
p.(None): in accordance with applicable law.
p.(None): 5.18. Monitoring
p.(None): 5.18.1. Purpose
p.(None): The purpose of monitoring the test is to confirm:
p.(None): a) that the protection of the rights and welfare of the respondents is ensured;
p.(None): b) the accuracy and completeness of the test data and compliance with the original documents;
p.(None): c) the examination is carried out in accordance with the valid approved Protocol and its amendments
p.(None): and amendments, with Good Clinical Practice and applicable legislation.
p.(None): 5.18.2. Monitor selection and qualifications
p.(None): a) The sponsor should provide a monitor,
p.(None): b) The monitor should have the appropriate qualifications and scientific and / or clinical knowledge to perform
p.(None): appropriate monitoring of testing. Monitor qualifications should be documented,
p.(None): c) The monitor should be fully familiar with the product being tested, the Protocol, the written form
p.(None): consent and other written notices intended for respondents, with standard
p.(None): operational procedures and applicable legal regulations.
p.(None): 5.18.3. Scope and nature of monitoring
p.(None): The sponsor should ensure proper monitoring of the trials as well as determine the appropriate one
...
p.(None): procedure.
p.(None): e) When provided by applicable law or regulations, the sponsor is required to submit a certificate of completion
p.(None): oditu.
p.(None): 5.20. Mismatch
p.(None): 5.20.1. In case of non-adherence to the Protocol, standard operating procedures, good clinical practice
p.(None): and / or applicable legislation by the researcher / institution or member of the sponsor's team, the sponsor should
p.(None): to take urgent measures to ensure compliance.
p.(None): 5.20.2. If the monitoring and / or departure process establishes a serious and / or permanent deviation from
p.(None): plan by the researcher / institution, the sponsor should terminate his participation in the
p.(None): examination. When the participation of the researcher / institution is terminated due to discrepancies, the sponsor shall do so
p.(None): it must immediately inform the competent authorities.
p.(None): 5.21. Premature completion or delay of clinical trial
p.(None): If the examination is interrupted or delayed, the sponsor should immediately inform the researcher / institution
p.(None): and the competent authorities and give reasons for termination or delay. Also, sponsor or researcher / institution, depending on
p.(None): current legislation, you should immediately notify the Ethics Committee and provide reasons for termination or adjournment.
p.(None): 5.22. Clinical trial reports
p.(None): Whether the examination is completed or terminated, the sponsor should ensure that a report is prepared and submitted
p.(None): clinical trial to competent authorities in accordance with applicable legal requirements. The sponsor should also provide
p.(None): that clinical trial reports form an integral part of the application for marketing authorization
p.(None): marketed drug, formed according to the "ICH" Guidelines for the Structure and Content of Clinical Trial Reports.
p.(None): (NOTE: The "ICH" guidelines for the structure and content of clinical trial reports allow for abbreviated
p.(None): reports in some cases).
p.(None): 5.23. Multicenter trials
p.(None): For multicenter trials, the sponsor should ensure that:
p.(None): 5.23.1. That all researchers conduct the examination strictly in accordance with the Protocol agreed with
p.(None): sponsored and approved by the competent authorities and, if requested, for which approval / positive opinion exists
p.(None): Ethics Committee.
p.(None): 5.23.2. That the test list form allows you to view all the required information in each center
p.(None): multicenter testing. Those researchers who collect additional data should submit a supplementary test
p.(None): lists whose form also allows additional information to be recorded.
p.(None): 5.23.3. That the duties of the research coordinator and other researchers have been documented before the start of the examination.
p.(None): 5.23.4. That all researchers were given instructions on adhering to the Protocol, adherence to unique standards for
p.(None): evaluation of clinical and laboratory results and completion of test lists.
p.(None): 5.23.5. Simplified communication between researchers.
p.(None): 6. CLINICAL TESTING PROTOCOL AND ITS AMENDMENTS AND APPENDICES
p.(None): The clinical trial protocol should include the sections listed in this chapter. However, data related to
p.(None): the test center may be indicated on the separate pages of the Protocol or laid down in a separate contract,
p.(None): and some of the information below may be part of other documentation, such as the Explorer Booklet.
p.(None): 6.1. General information
...
p.(None): allowed before or during the examination.
p.(None): 6.6.3. Procedures for monitoring compliance with the test plan by the respondent.
p.(None): 6.7. Evaluation of efficiency
p.(None): 6.7.1. Determination of efficiency parameters.
p.(None): 6.7.2. Methods and timeframe for estimating, recording and analyzing efficiency parameters.
p.(None): 6.8. Security assessment
p.(None): 6.8.1. Determining security parameters.
p.(None): 6.8.2. Methods and time period for estimating, recording and analyzing security parameters.
p.(None): 6.8.3. Procedures for recording and reporting adverse events and associated diseases.
p.(None): 6.8.4. The manner and length of the follow-up period of the respondent after an adverse event.
p.(None): 6.9. Statistical data
p.(None): 6.9.1. A description of the statistical methods that will be applied, including the time for any planned
p.(None): interanalysis.
p.(None): 6.9.2. Number of planned respondents. In multicenter trials, the planned number should be indicated
p.(None): respondents for each testing center. Reason for choosing a specific sample size (number
p.(None): subjects), including the impact on the significance of the trial and its clinical justification.
p.(None): 6.9.3. The degree of significance that will be used.
p.(None): 6.9.4. Criteria for completing the test.
p.(None): 6.9.5. Procedures for explaining gaps, unused or false information.
p.(None): 6.9.6. Procedures for reporting deviations from the original statistical plan (any
p.(None): deviation from the original statistical plan should be described and explained in the Protocol and / or final
p.(None): report).
p.(None): 6.9.7. Selection of respondents to be included in the analyzes (eg all randomized, received subjects
p.(None): drug tested, eligible subjects, evaluable subjects).
p.(None): 6.10. Direct access to original data / documents The sponsor should ensure that it is in the Protocol or another
p.(None): indicate in the written document that the researcher / institution will allow monitoring and departure, considered by the Ethical
p.(None): board and inspection by the competent authorities, by allowing access to the original
p.(None): data / documents.
p.(None): 6.11. Quality assurance and quality control
p.(None): 6.12. Ethical aspects of testing
p.(None): Description of ethical considerations related to clinical trial.
p.(None): 6.13. Handling data and keeping records
p.(None): 6.14. Financing and insurance
p.(None): The method of financing and insurance should be indicated only if they are not specified in a separate contract.
p.(None): 6.15. Publication policy
p.(None): The agreement to publish the test results should be stated only if they are not specified in a separate contract.
p.(None): 6.16. Extras
p.(None): (Note: Given that the Protocol and clinical trial / study report are very close,
p.(None): additional information can be found in the "ICH" Guidelines for the structure and content of clinical trial reports.)
p.(None): 7. RESEARCH BROCHURE
p.(None): 7.1. Introduction
p.(None): The Researcher's Brochure is a collection of clinical and preclinical data on the product under study that is important
p.(None): for testing it on humans. Its purpose is to provide researchers and other persons involved in
p.(None): examination of information that facilitates understanding and facilitates adherence to the Clinical Protocol
p.(None): tests, clarify many protocol items such as dosage, dosage regimen, route of administration, and control procedures
...
p.(None): consideration of the importance of the results for the tested beneficial or potential adverse effects in humans.
p.(None): - species of experimental animals;
p.(None): - number and half of animals in each group;
p.(None): - unit dose (eg mg / kg);
p.(None): - dose interval;
p.(None): - method of administration;
p.(None): - length of application;
p.(None): - system allocation information;
p.(None): - the length of the follow-up period after therapy;
p.(None): - the results, including the following aspects:
p.(None): - the nature and frequency of pharmacological and toxicological reactions;
p.(None): - severity and intensity of pharmacological and toxicological reactions;
p.(None): - the time of their beginning;
p.(None): - Reversibility of reactions;
p.(None): - duration of reactions;
p.(None): - dose-response.
p.(None): For the sake of clarity, it is preferable that the data be presented in tabular form.
p.(None): In the sections below, the most important results of the preclinical trials, including those observed, should be considered
p.(None): effects at administered doses, relevance to human administration, and other aspects to be studied
p.(None): people. If possible, the results of administering effective and non-toxic doses for the same species should be compared
p.(None): animals (e.g. consider therapeutic index). The importance of all data in the planning of dosing should be considered
p.(None): in humans. Whenever possible, the dosage should be based on blood / tissue levels, not mg / kg.
p.(None): (1) Preclinical pharmacology
p.(None): A summary of the pharmacological aspects of the product under study and significant metabolic studies should be provided
p.(None): to animals, where it exists. Such summary should include tests where possible
p.(None): therapeutic effect of the drug (eg mode of action, receptor binding and specificity) and its
p.(None): safety (eg special studies of pharmacological effects other than therapeutic).
p.(None): (2) Pharmacokinetics and metabolism of the test product in animals
p.(None): The pharmacokinetics, biotransformation and distribution of the test product in all animals should be summarized
p.(None): who have undergone preclinical research. Resorption should be considered when considering the results
p.(None): and the local and systemic bioavailability of the test product and its metabolites as well as their own
p.(None): correlation with pharmacological and toxicological findings from animal species experiments.
p.(None): (3) Toxicology
p.(None): The summary should describe the toxic effects from significant studies carried out on different animal species, namely
p.(None): that it contains the following:
p.(None): - single dose;
p.(None): - repeated dose;
p.(None): - carcinogenicity;
p.(None): - special tests (eg irritation and sensitization);
p.(None): - reproductive toxicology;
p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
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p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
p.(None): metabolism, if necessary), as well as information on the dose dependence of the effect obtained from earlier studies
p.(None): tests in humans (healthy volunteers and / or patients). The significance of this data should be considered. Where it is
p.(None): completed multiple clinical trials, review summaries of safety findings and
p.(None): efficacy by indication or subgroup can give a clear view of the data. Together
p.(None): a tabular summary of adverse reactions to the product under study (for all indications tested) can be very significant.
p.(None): Significant differences in adverse reactions to the indications and subgroups of subjects should be considered.
p.(None): The booklet for the researcher should describe the possible risks and side effects of the drug on the basis
p.(None): previous experience with the product tested and related drugs. Warnings and specials should also be mentioned
p.(None): measures as an integral part of the application of the test product.
p.(None): (3) Experiences after placing the test product on the market The Brochure should indicate the countries where it is
p.(None): interrogated
p.(None): the product has been granted marketing authorization. A summary of all relevant information obtained from
p.(None): markets (e.g., formulations, dosage, routes of administration, adverse reactions). The Brochure should, too
p.(None): indicate the countries in which the product tested has not been approved, or is
p.(None): withdrawn from the market, ie his registration was revoked.
p.(None): 7.3.7. Data Summary and Researcher's Guide
p.(None): This chapter should include a comprehensive review of preclinical and clinical data and provide a summary
p.(None): different aspects of the tested product based on data from different sources. This is given to the researcher
p.(None): the most relevant presentation of the data available and an evaluation of their significance for future clinical
p.(None): testing.
p.(None): When available, published reports of related products should be considered. The researcher can
p.(None): help predict adverse reactions to the product being tested or other problems in the clinical trial.
p.(None): The aim of this chapter is to provide the researcher with a clear insight into the possible risks and side effects, u
p.(None): specific tests,
p.(None): observations and precautions that may be required during the clinical trial. Insights need to be made
p.(None): be based on available physical, chemical, pharmaceutical, pharmacological, toxicological and
p.(None): clinical data on the product tested. The researcher should also be given guidelines for identifiable and
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Searching for indicator influence:
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p.(None): of items 4.8.10. when, in the opinion of the Ethics Committee, such supplementary information
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p.(None): Monday, March 12, 2012
p.(None): can significantly contribute to the protection of the rights, safety and / or well-being of respondents.
p.(None): 3.1.6. When should a non-therapeutic clinical trial be conducted for which legal consent is required
p.(None): (see 4.8.12, 4.8.14), the Ethics Committee should determine whether they are in the proposed Testing Protocol
p.(None): and / or other documentation sufficiently considered ethical issues and whether they meet current legal requirements
p.(None): regulations for such tests.
p.(None): 3.1.7. When the Examination Protocol indicates that it is not possible to obtain the consent of the subjects in a timely manner or
p.(None): of his legal representative (ie in an emergency, see 4.8.15), the Ethics Committee should determine whether
p.(None): the proposed Testing Protocol and / or other documentation sufficiently considered ethical issues and whether
p.(None): meet the applicable legal requirements for such tests.
p.(None): 3.1.8. The Ethics Committee considers the amount and method of payment of reimbursement to respondents to remove
p.(None): the potential for forcible or inappropriate influence on the respondents. Payment of compensation is required
p.(None): distribute in installments, not the full amount upon completion of respondent's participation in
p.(None): examination.
p.(None): 3.1.9. The Ethics Committee should provide payment information to the respondents, including manner, amount and schedule
p.(None): payments, to be defined in the respondent's written consent form, as well as in any other written notice
p.(None): for the respondents. The method of payment in proportionate installments should be indicated.
p.(None): 3.2. Composition, functions and procedures
p.(None): 3.2.1. The ethics committee should be composed of persons who have the appropriate qualifications and experience required for
p.(None): consideration and evaluation of the scientific, medical and ethical aspects of the proposed test. It is recommended that Ethical
p.(None): committee:
p.(None): a) has at least five members;
p.(None): b) at least one member whose sphere of interest is unscientific;
p.(None): c) at least one member independent of the institution or the place where the examination is conducted.
p.(None): To prevent conflicts of interest, only those Ethics Committee members who are not researchers and are independent of
p.(None): sponsors can vote, or give their opinion on clinical trial issues. Member list
p.(None): The Ethics Committee and their qualifications should be separately kept and regularly updated.
p.(None): 3.2.2. The Ethics Committee should perform its function in accordance with written standard operating procedures,
...
p.(None): connects the respondent and the product under investigation (eg accidentally or due to a serious adverse event).
p.(None): 4.8. Consent of respondents
p.(None): Issue 19 - Page 56 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 4.8.1. In the process of obtaining and recording the consent of the respondents, the researcher should adhere to the valid ones
p.(None): legislation, good clinical practice and ethical principles stemming from the Declaration of Helsinki. Before you begin
p.(None): examinations, the researcher should have the written approval / positive opinion of the Ethics Committee on the written form
p.(None): consent to other written notices intended for the respondents.
p.(None): 4.8.2. The written consent form of the respondents and all other written information intended for the respondents should be provided
p.(None): amendments after each new information that might affect the consent of the respondents. Before application,
p.(None): Amended respondent consent form and other written notice intended
p.(None): respondents should be approved / approved by the Ethics Committee. Respondent respectively his / her legal
p.(None): the deputy should be informed in good time of any new information that may influence the decision
p.(None): respondents to continue participation in the examination. Information on this shall be kept in writing.
p.(None): 4.8.3. Neither the researcher nor the staff participating in the test shall coerce or inappropriately influence
p.(None): respondents to participate in, or continue to participate in, the examination.
p.(None): 4.8.4. None of the oral and written examination-related information, including consent form
p.(None): respondents should not be written in a language that would deprive the respondent or his legal representative
p.(None): any legal right, or by which the researcher, institution, sponsor or his representative would be exonerated
p.(None): liability for negligence.
p.(None): 4.8.5. The researcher or the person designated by the researcher should inform the respondent, that is, his / her legal
p.(None): if the respondent is not competent to give consent, on all aspects of the examination, including written notices
p.(None): for which approval / positive opinion of the Ethics Committee has been obtained.
p.(None): 4.8.6. Language used in oral and written examination notices, including
p.(None): the respondent's consent form should not contain expert terminology but should be understandable to the respondent
p.(None): that is, his legal representative and impartial witness.
p.(None): 4.8.7. Before obtaining consent, the researcher or the person appointed by the researcher should provide
p.(None): respondent or his / her legal representative sufficient time and opportunity to find out details about
p.(None): examination to decide whether or not to participate in it. All questions related to the examination should
...
p.(None): the availability and their potential risks and benefits;
p.(None): j) compensation and / or treatment provided to the respondent in case of injury caused by the examination;
p.(None): k) the estimated schedule of payment of installments of any compensation to the respondents for participation in the examination;
p.(None): l) any other costs foreseen for the respondent to participate in the examination;
p.(None): m) that the respondent's participation in the examination is voluntary and that the respondent may leave at any time
p.(None): that is, to interrupt the examination without suffering any consequences of its decision;
p.(None): n) that the monitor, the auditor, the Ethics Committee and the competent authorities will have direct access to the original healthcare
p.(None): the data of the subjects for the purpose of verifying the procedures, ie obtained data in the clinical trial, with full protection
p.(None): secrecy of the respondent's identity within the limits of the applicable laws and regulations, as well as that of the respondent or his
p.(None): the legal representative permits such access to the data by signing informed consent;
p.(None): o) that the personal data of the respondents will be confidential and that, within the limits of the applicable laws and / or
p.(None): regulations, will not be available to the public. If the test results are published, the identities of the respondents will remain
p.(None): in secret;
p.(None): p) that the respondent or his legal representative will be informed in a timely manner of new ones
p.(None): insights that could influence the respondent's decision to continue participating in the examination;
p.(None): r) contact person information for questioning information and interviewee rights as well as o
p.(None): contacting the person for possible injury arising from participation in the examination;
p.(None): s) the foreseeable circumstances and / or reasons why the respondent participates in the examination
p.(None): can end;
p.(None): t) the expected duration of the respondent's participation in the examination;
p.(None): u) the indicative number of respondents envisaged for the examination.
p.(None): 4.8.11. The respondent or his / her legal representative should receive a copy before entering the examination
p.(None): signed and dated written consent form as well as other written notice intended
p.(None): to the respondents. While participating in the examination, the respondent or his legal representative should
p.(None): receive signed and dated copies of the updated consent form as well as copies of changes and
p.(None): supplement to information intended for respondents.
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 57
p.(None): 4.8.12. When a clinical trial (whether therapeutic action is expected or not) involves subjects for
p.(None): whose participation requires the consent of a legal representative (eg minors or patients with severe
p.(None): dementia), such respondents should be introduced to the examination in accordance with their ability to understand and from those
p.(None): who are able to obtain a signed and dated written consent form.
p.(None): 4.8.13. In addition to the one described under 4.8.14, non-therapeutic testing (ie a non-
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p.(None): signed and dated patient informed consent form.
p.(None): 1.29. Inspection
p.(None): Procedure by the competent authorities to carry out an official review of documents, institutions, files and all
p.(None): other information that authorities believe is related to the clinical trial and can be found at the site of the study
p.(None): clinical trial, with sponsors and / or contracting research organizations, or others
p.(None): Issue 19 - Page 52 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): institutions that the competent authorities deem appropriate for assessment.
p.(None): 1.30. Institution (medical)
p.(None): One or more healthcare facilities where the clinical trial is being conducted.
p.(None): 1.31. Institutional Ethics Committee
p.(None): An independent body made up of medical, scientific or non-scientific members whose responsibility is insurance
p.(None): protection of the rights, safety and well-being of the subjects involved in the clinical trial, among others
p.(None): controlling, approving and ensuring ongoing review of the Clinical Trial Protocol and its annexes,
p.(None): as well as the method for obtaining and documenting the consent of the respondents.
p.(None): 1.32. Clinical trial progress report
p.(None): Report on the results of the clinical trial and their evaluation based on the analysis conducted for
p.(None): a specific period of time during the clinical trial.
p.(None): 1.33. Tested product
p.(None): The pharmaceutical form of the active substance being tested or the placebo with which the test substance is compared,
p.(None): including a product that has a marketing authorization if its use or method (form
p.(None): or packaging) different from the approved one, or, if applicable for an indication that is not approved,
p.(None): or used to obtain new information on an approved application.
p.(None): 1.34. Explorer
p.(None): The person responsible for conducting the clinical trial at the place where it is conducted. If testing on someone
p.(None): The site is run by a research team, the researcher responsible for conducting the clinical trial is
p.(None): principal investigator.
p.(None): 1.35. Researcher / Institution
p.(None): The term "researcher and / or institution" is used if required by applicable regulations.
p.(None): 1.36. Brochure for the researcher
p.(None): A set of clinical and preclinical data on a test product relevant to its testing in humans
p.(None): (see
p.(None): 7. Researcher Brochure).
p.(None): 1.37. Legal representative
p.(None): An individual or a legal or other body empowered by applicable law to give consent on behalf of respondents
p.(None): participation in a clinical trial.
p.(None): 1.38. Monitoring
p.(None): The process of monitoring the clinical trial process and confirming that implementation, documentation, and
p.(None): reporting in accordance with the Clinical Trial Protocol, standard operating procedures, Good
p.(None): clinical practice and applicable law.
p.(None): 1.39. Monitoring report
p.(None): A written report that the monitor submits to the sponsor after each visit to the examination center, as well as a report on
p.(None): any new knowledge regarding testing in accordance with the sponsor's standard operating procedures.
p.(None): 1.40. Multicenter clinical trial
p.(None): A clinical trial conducted in accordance with the unique clinical trial protocol in
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p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 65
p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
p.(None): metabolism, if necessary), as well as information on the dose dependence of the effect obtained from earlier studies
p.(None): tests in humans (healthy volunteers and / or patients). The significance of this data should be considered. Where it is
p.(None): completed multiple clinical trials, review summaries of safety findings and
p.(None): efficacy by indication or subgroup can give a clear view of the data. Together
p.(None): a tabular summary of adverse reactions to the product under study (for all indications tested) can be very significant.
p.(None): Significant differences in adverse reactions to the indications and subgroups of subjects should be considered.
p.(None): The booklet for the researcher should describe the possible risks and side effects of the drug on the basis
p.(None): previous experience with the product tested and related drugs. Warnings and specials should also be mentioned
p.(None): measures as an integral part of the application of the test product.
p.(None): (3) Experiences after placing the test product on the market The Brochure should indicate the countries where it is
p.(None): interrogated
p.(None): the product has been granted marketing authorization. A summary of all relevant information obtained from
p.(None): markets (e.g., formulations, dosage, routes of administration, adverse reactions). The Brochure should, too
p.(None): indicate the countries in which the product tested has not been approved, or is
p.(None): withdrawn from the market, ie his registration was revoked.
p.(None): 7.3.7. Data Summary and Researcher's Guide
p.(None): This chapter should include a comprehensive review of preclinical and clinical data and provide a summary
p.(None): different aspects of the tested product based on data from different sources. This is given to the researcher
p.(None): the most relevant presentation of the data available and an evaluation of their significance for future clinical
p.(None): testing.
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p.(None): Document describing the objectives, plan, test methodology, method of statistical data processing and
p.(None): organization of testing. The protocol usually contains either an introduction and a rational basis for testing or this may
p.(None): be described by a protocol amendment.
p.(None): 1.45. Changes and additions to the Clinical Trial Protocol
p.(None): Description of the modification of the Clinical Trial Protocol in writing, or its official explanation.
p.(None): 1.46. Quality assurance
p.(None): All planned and systematic activities aimed at ensuring consistency of implementation
p.(None): clinical trial, documenting results and reporting with Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 1.47. Quality control
p.(None): Operational techniques and quality assurance activities aimed at verifying that they are
p.(None): all the quality requirements related to the test are met.
p.(None): 1.48. Randomization
p.(None): The process of randomly selecting (classifying) subjects into a therapeutic or control group, thereby reducing it
p.(None): researcher bias.
p.(None): 1.49. Competent authorities
p.(None): Bodies competent for the adoption of legislation. For the purposes of these guidelines, the term competent authorities includes bodies which
p.(None): have the regulatory power to legislate including review a submitted clinical
p.(None): documentation and inspection (see 1.29).
p.(None): 1.50. Serious adverse event or serious adverse reaction
p.(None): Any undesirable medical phenomenon related to the health of the subjects causing at any dose:
p.(None): - death,
p.(None): - Immediate threat to life,
p.(None): - requires or extends existing hospitalization,
p.(None): - permanent or significant disability or disability,
p.(None): - congenital anomalies, that is, a birth defect.
p.(None): 1.51. Original data
p.(None): Original medical records from original documents and certified copies of original clinical and laboratory records
p.(None): findings or other results of activities performed during the clinical trial that are required for
p.(None): evaluation of test results.
p.(None): The original information is contained in the original documentation (as originals or certified copies).
p.(None): 1.52. Original documentation
p.(None): Source documents, data and records (e.g., medical history, clinical and administrative records,
p.(None): laboratory findings, memos, subjects' diaries or test lists, drug dispensing records, recorded
p.(None): automated device data, copies and transcripts verified after authentication, negatives,
p.(None): microfilms and magnetic recordings, x-rays, pharmacy records, laboratories and
p.(None): medical-technical services involved in the clinical trial).
p.(None): 1.53. Sponsor
p.(None): Individual or legal entity responsible for initiating, conducting and / or financing a clinical
p.(None): testing.
p.(None): 1.54. Sponsor - Researcher
p.(None): An individual who initiates and conducts a clinical trial, alone or with others, and under whose immediate supervision
p.(None): the test product is prescribed, dispensed, or applied by the respondent. This one
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 53
p.(None): the term is restricted to natural persons (ie does not include legal persons such as corporations or agencies).
p.(None): The duties of sponsor - researcher are combined the duties of sponsor and researcher
p.(None): 1.55. Standard Operating Procedures ("SOPs")
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Health / Mentally Incapacitated
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p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
p.(None): experience to perform their tasks.
p.(None): 2.9. Prior to enrolling in a clinical trial, each subject should voluntarily consent to participate in a clinical trial
p.(None): examination.
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Health / Motherhood/Family
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p.(None): 4.1.5. The researcher should draw up a list of appropriately qualified persons to whom he or she has been assigned
p.(None): significant testing obligations.
p.(None): 4.2. Appropriate options
p.(None): 4.2.1. The researcher should document (eg retrospective data) the potential for recruitment
p.(None): the required number of appropriate respondents in the agreed period.
p.(None): 4.2.2. The researcher should have sufficient time to properly conduct and complete the examination within the agreed time
p.(None): deadline.
p.(None): 4.2.3. For the test to be conducted properly and safely, the researcher should have a sufficient number
p.(None): qualified personnel and appropriate facilities and equipment requirements.
p.(None): 4.2.4. The researcher must ensure that the personnel involved in the examination are properly informed of
p.(None): The protocol, the product being tested and its obligations and functions related to the testing.
p.(None): 4.3. Medical care of respondents
p.(None): 4.3.1. Qualified Doctor of Medicine, or if necessary Doctor of Dentistry, who
p.(None): the researcher or investigator in the clinical trial should be responsible for bringing all medical
p.(None): testing decisions.
p.(None): 4.3.2. During and after the participation of the respondents in the examination, the researcher / institution should ensure that it is appropriate
p.(None): medical care to respondents in the event of any adverse event related to the trial,
p.(None): including clinically relevant laboratory findings. Does the researcher / institution find that
p.(None): the respondent, meanwhile, was ill with some illness, should be informed of the need for his treatment.
p.(None): 4.3.3. It is recommended that the researcher inform the respondent's family doctor of his
p.(None): participation in the examination, if the respondent has it and agrees.
p.(None): 4.3.4. Although the respondent is not required to explain the reasons for his or her early withdrawal from the examination, the investigator does
p.(None): reasonable efforts should be made to determine the reasons, with full respect for the rights of the respondents.
p.(None): 4.4. Communication with the Ethics Committee
p.(None): 4.4.1. Prior to the start of the test, the researcher / institution should have written and dated approval / positive
p.(None): opinion of the Ethics Committee on the Testing Protocol, the written consent form and its amendments, the procedure for
p.(None): the recruitment of respondents (eg through advertisements) and any other written information intended for the respondents.
p.(None): 4.4.2. An integral part of the written request submitted by the researcher / institution to Ethics
p.(None): the board is also the current version of the Researcher Brochure. If there is an amendment to the Brochure for
p.(None): researchers during the examination, the researcher / institution is obliged to submit to the Ethics Committee
p.(None): updated Brochures.
p.(None): 4.4.3. During the examination, the researcher / institution shall submit to the Ethics Committee all documents that are
p.(None): subject to change.
p.(None): 4.5. Protocol Compliance
p.(None): 4.5.1. The investigator / institution should carry out the test in accordance with the Test Protocol
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Health / Physically Disabled
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p.(None): 4.1.4. The researcher / institution should allow the sponsor to monitor and leave, as well as inspection by the competent
p.(None): bodies.
p.(None): 4.1.5. The researcher should draw up a list of appropriately qualified persons to whom he or she has been assigned
p.(None): significant testing obligations.
p.(None): 4.2. Appropriate options
p.(None): 4.2.1. The researcher should document (eg retrospective data) the potential for recruitment
p.(None): the required number of appropriate respondents in the agreed period.
p.(None): 4.2.2. The researcher should have sufficient time to properly conduct and complete the examination within the agreed time
p.(None): deadline.
p.(None): 4.2.3. For the test to be conducted properly and safely, the researcher should have a sufficient number
p.(None): qualified personnel and appropriate facilities and equipment requirements.
p.(None): 4.2.4. The researcher must ensure that the personnel involved in the examination are properly informed of
p.(None): The protocol, the product being tested and its obligations and functions related to the testing.
p.(None): 4.3. Medical care of respondents
p.(None): 4.3.1. Qualified Doctor of Medicine, or if necessary Doctor of Dentistry, who
p.(None): the researcher or investigator in the clinical trial should be responsible for bringing all medical
p.(None): testing decisions.
p.(None): 4.3.2. During and after the participation of the respondents in the examination, the researcher / institution should ensure that it is appropriate
p.(None): medical care to respondents in the event of any adverse event related to the trial,
p.(None): including clinically relevant laboratory findings. Does the researcher / institution find that
p.(None): the respondent, meanwhile, was ill with some illness, should be informed of the need for his treatment.
p.(None): 4.3.3. It is recommended that the researcher inform the respondent's family doctor of his
p.(None): participation in the examination, if the respondent has it and agrees.
p.(None): 4.3.4. Although the respondent is not required to explain the reasons for his or her early withdrawal from the examination, the investigator does
p.(None): reasonable efforts should be made to determine the reasons, with full respect for the rights of the respondents.
p.(None): 4.4. Communication with the Ethics Committee
p.(None): 4.4.1. Prior to the start of the test, the researcher / institution should have written and dated approval / positive
p.(None): opinion of the Ethics Committee on the Testing Protocol, the written consent form and its amendments, the procedure for
p.(None): the recruitment of respondents (eg through advertisements) and any other written information intended for the respondents.
p.(None): 4.4.2. An integral part of the written request submitted by the researcher / institution to Ethics
p.(None): the board is also the current version of the Researcher Brochure. If there is an amendment to the Brochure for
p.(None): researchers during the examination, the researcher / institution is obliged to submit to the Ethics Committee
p.(None): updated Brochures.
p.(None): 4.4.3. During the examination, the researcher / institution shall submit to the Ethics Committee all documents that are
p.(None): subject to change.
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p.(None): 4.1.3. The researcher must be familiar with and adhere to Good Clinical Practice and applicable law.
p.(None): 4.1.4. The researcher / institution should allow the sponsor to monitor and leave, as well as inspection by the competent
p.(None): bodies.
p.(None): 4.1.5. The researcher should draw up a list of appropriately qualified persons to whom he or she has been assigned
p.(None): significant testing obligations.
p.(None): 4.2. Appropriate options
p.(None): 4.2.1. The researcher should document (eg retrospective data) the potential for recruitment
p.(None): the required number of appropriate respondents in the agreed period.
p.(None): 4.2.2. The researcher should have sufficient time to properly conduct and complete the examination within the agreed time
p.(None): deadline.
p.(None): 4.2.3. For the test to be conducted properly and safely, the researcher should have a sufficient number
p.(None): qualified personnel and appropriate facilities and equipment requirements.
p.(None): 4.2.4. The researcher must ensure that the personnel involved in the examination are properly informed of
p.(None): The protocol, the product being tested and its obligations and functions related to the testing.
p.(None): 4.3. Medical care of respondents
p.(None): 4.3.1. Qualified Doctor of Medicine, or if necessary Doctor of Dentistry, who
p.(None): the researcher or investigator in the clinical trial should be responsible for bringing all medical
p.(None): testing decisions.
p.(None): 4.3.2. During and after the participation of the respondents in the examination, the researcher / institution should ensure that it is appropriate
p.(None): medical care to respondents in the event of any adverse event related to the trial,
p.(None): including clinically relevant laboratory findings. Does the researcher / institution find that
p.(None): the respondent, meanwhile, was ill with some illness, should be informed of the need for his treatment.
p.(None): 4.3.3. It is recommended that the researcher inform the respondent's family doctor of his
p.(None): participation in the examination, if the respondent has it and agrees.
p.(None): 4.3.4. Although the respondent is not required to explain the reasons for his or her early withdrawal from the examination, the investigator does
p.(None): reasonable efforts should be made to determine the reasons, with full respect for the rights of the respondents.
p.(None): 4.4. Communication with the Ethics Committee
p.(None): 4.4.1. Prior to the start of the test, the researcher / institution should have written and dated approval / positive
p.(None): opinion of the Ethics Committee on the Testing Protocol, the written consent form and its amendments, the procedure for
p.(None): the recruitment of respondents (eg through advertisements) and any other written information intended for the respondents.
p.(None): 4.4.2. An integral part of the written request submitted by the researcher / institution to Ethics
p.(None): the board is also the current version of the Researcher Brochure. If there is an amendment to the Brochure for
p.(None): researchers during the examination, the researcher / institution is obliged to submit to the Ethics Committee
p.(None): updated Brochures.
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Social / Access to Social Goods
Searching for indicator access:
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p.(None): of the drug, which summarizes clinically and statistically significant data, findings and analyzes obtained
p.(None): test results. (see "ICH" Guidelines for the Structure and Content of the Clinical Report
p.(None): examination).
p.(None): 1.14. Comparative product
p.(None): Tested or marketed product (i.e. active control) or placebo to compare drug / medical
p.(None): the product being clinically tested.
p.(None): 1.15. Compliance with the adopted clinical trial plan
p.(None): Compliance with all clinical trial requirements, Good Clinical Practice and applicable legal requirements.
p.(None): 1.16. Confidentiality
p.(None): Preventing the disclosure of proprietary information owned by the sponsor or disclosing the identity of the respondents,
p.(None): except for authorized ones.
p.(None): 1.17. The contract
p.(None): A written, dated and signed contract between two or more parties involved in determining the assignments,
p.(None): delegation and allocation of tasks and responsibilities, and financial matters if necessary. The contract may be based on
p.(None): Protocol.
p.(None): 1.18. Coordination committee
p.(None): A sponsor-based committee to conduct a multicenter clinical trial in concert.
p.(None): 1.19. Researcher Coordinator
p.(None): Researcher responsible for coordinating researchers at different participating multicenter centers
p.(None): examination.
p.(None): 1.20. Contract Research Organization (CRO)
p.(None): A legal or natural person who contracts with a sponsor of a clinical trial based on which of the sponsors
p.(None): assumes all or part of the authorization in the clinical trial.
p.(None): 1.21. Direct access to data
p.(None): Permission to view, analyze, verify and transmit all data and reports relevant to clinical evaluation
p.(None): testing.
p.(None): Any party having direct access to the documentation (eg domestic or foreign authorities, monitors and
p.(None): auditors) is obliged to take all reasonable precautions within the applicable legal provisions in order to preserve
p.(None): the secrecy of the identity of the respondents and the data owned by the sponsor
p.(None): 1.22. Clinical trial documentation
p.(None): All data in any format (including written, electronic, magnetic and optical records and
p.(None): recordings, x-rays, electrocardiograms, etc.) describing or recording methods, and conducting and / or
p.(None): the results of the clinical trial, the factors affecting it, and the measures taken.
p.(None): 1.23. Basic documentation
p.(None): Documents that, individually or together, provide an assessment of the conduct of the clinical trial and the quality
p.(None): the data obtained (see 8. Basic documents for conducting the clinical trial).
p.(None): 1.24. Good clinical practice
p.(None): Good Clinical Practice (GCP) is an international ethical and scientific system
p.(None): the quality of planning, performing, recording, monitoring and reporting on clinical trial at
p.(None): people, which enables the credibility of the information obtained during the examination and protection of rights
p.(None): and the safety of the respondent in accordance with the Declaration of Helsinki on the Protection of Patients' Rights (u
p.(None): (hereinafter referred to as the Declaration of Helsinki).
p.(None): 1.25. Independent Data Monitoring Committee
p.(None): An independent data monitoring committee may establish a sponsor in order to conduct a periodic assessment of the clinical course
p.(None): tests, safety data and key performance conclusions, and which he recommends
p.(None): sponsor continuation, modification, or termination of clinical trial.
...
p.(None): respondents should include the following explanations:
p.(None): a) the clinical trial is of a research nature;
p.(None): b) the objective of the examination;
p.(None): c) the therapy being tested and the possibility of accidental inclusion in one of the treatment groups;
p.(None): d) the procedures provided for in the test, including invasive procedures;
p.(None): e) Respondents' duties;
p.(None): f) experimental aspects of testing;
p.(None): g) the foreseeable risks and inconveniences for the respondent, ie embryo, fetus or infant;
p.(None): h) benefits that can be expected. When no clinical benefit is expected for the respondent,
p.(None): he must be warned;
p.(None): i) alternative therapeutic procedures and / or treatment options available to the respondent at
p.(None): the availability and their potential risks and benefits;
p.(None): j) compensation and / or treatment provided to the respondent in case of injury caused by the examination;
p.(None): k) the estimated schedule of payment of installments of any compensation to the respondents for participation in the examination;
p.(None): l) any other costs foreseen for the respondent to participate in the examination;
p.(None): m) that the respondent's participation in the examination is voluntary and that the respondent may leave at any time
p.(None): that is, to interrupt the examination without suffering any consequences of its decision;
p.(None): n) that the monitor, the auditor, the Ethics Committee and the competent authorities will have direct access to the original healthcare
p.(None): the data of the subjects for the purpose of verifying the procedures, ie obtained data in the clinical trial, with full protection
p.(None): secrecy of the respondent's identity within the limits of the applicable laws and regulations, as well as that of the respondent or his
p.(None): the legal representative permits such access to the data by signing informed consent;
p.(None): o) that the personal data of the respondents will be confidential and that, within the limits of the applicable laws and / or
p.(None): regulations, will not be available to the public. If the test results are published, the identities of the respondents will remain
p.(None): in secret;
p.(None): p) that the respondent or his legal representative will be informed in a timely manner of new ones
p.(None): insights that could influence the respondent's decision to continue participating in the examination;
p.(None): r) contact person information for questioning information and interviewee rights as well as o
p.(None): contacting the person for possible injury arising from participation in the examination;
p.(None): s) the foreseeable circumstances and / or reasons why the respondent participates in the examination
p.(None): can end;
p.(None): t) the expected duration of the respondent's participation in the examination;
p.(None): u) the indicative number of respondents envisaged for the examination.
p.(None): 4.8.11. The respondent or his / her legal representative should receive a copy before entering the examination
p.(None): signed and dated written consent form as well as other written notice intended
p.(None): to the respondents. While participating in the examination, the respondent or his legal representative should
p.(None): receive signed and dated copies of the updated consent form as well as copies of changes and
p.(None): supplement to information intended for respondents.
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 57
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p.(None): making these updates. The sponsor should have written procedures to ensure that the changes or
p.(None): test list corrections made by the named sponsor agent be
p.(None): documented, initialed and supported by the researcher. The researcher should keep a record of all changes and
p.(None): correction.
p.(None): 4.9.4. The investigator / institution should keep the examination documentation as specified in the Basic Documents section
p.(None): for conducting a clinical trial (see 8.), as well as with applicable legal regulations.
p.(None): The researcher / institution should take measures to prevent the accidental or early destruction of these
p.(None): of documents.
p.(None): 4.9.5. The basic documents should be kept for at least two years after the last approval was obtained
p.(None): of the marketing request in the "ICH" countries of the region as well as as long as there are unresolved or considered
p.(None): license applications in the "ICH" countries of the region, or at least two years after the official
p.(None): cessation of clinical development of the investigational product. These documents should be kept for a longer period of time
p.(None): period, if required by applicable law, or an agreement with the sponsor. He is a sponsor
p.(None): obliged to inform the researcher / institution when it is no longer necessary to keep this documentation (see 5.5.12).
p.(None): 4.9.6. The financial aspects of the test should be documented by a contract between the sponsor and the researcher / institution.
p.(None): 4.9.7. At the request of the monitor, the auditor, the Ethics Committee or the competent authorities, the investigator / institution is obliged to make it possible
p.(None): direct access to all documents related to the examination.
p.(None): 4.10. Test progress reports
p.(None): 4.10.1. The researcher should submit a written summary of the examination status to the Ethics Committee once a year or
p.(None): more often, at the request of the Ethics Committee.
p.(None): 4.10.2. The researcher should promptly submit a written report to the sponsor, the Ethics Committee (see 3.3.8) and, where
p.(None): to the healthcare institution, on changes that significantly affect the conduct of the examination and / or
p.(None): increase the risk for respondents.
p.(None): 4.11. Security reporting
p.(None): 4.11.1. All serious adverse events in the clinical trial should be reported to the sponsor immediately,
p.(None): except those which are not stated in the Protocol or other document (eg the Researcher's Brochure)
p.(None): should be reported immediately. A detailed event report should be written immediately after the application. That report
p.(None): instead of the respondent's name, unique identification number and / or address, the respondent should be identified
p.(None): predominantly by the original code number assigned to the respondent. The researcher should also adhere to the applicable ones
p.(None): legal regulations concerning reporting to the competent authorities and the Ethics Committee on unexpected serious
p.(None): adverse reactions to the drug.
p.(None): 4.11.2. Adverse events and / or unusual laboratory findings identified by the Protocol as critical to
...
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p.(None): Monday, March 12, 2012
p.(None): 4.12.2. If the sponsor interrupts or postpones the examination (see 5.21), the investigator should be informed immediately
p.(None): institution and the researcher / institution should immediately inform the Ethics Committee and provide them in writing
p.(None): explanation of interruption or delay.
p.(None): 4.12.3. If the Ethics Committee withdraws its approval / positive opinion on the examination
p.(None): (see 3.1.2 and 3.3.9), the researcher is obliged to inform the institution and the researcher / institution should
p.(None): immediately notify the sponsor and provide them with a detailed written explanation of the interruption or delay.
p.(None): 4.13. Final report from the researcher
p.(None): Upon completion of the examination, the investigator should inform the institution that the examination has been completed;
p.(None): the researcher / institution should submit to the Ethics Committee a summary of the test results and all to the competent authorities
p.(None): required reports.
p.(None): 5. SPONSOR
p.(None): 5.1. Quality assurance and control
p.(None): 5.1.1. The sponsor is responsible for the implementation and quality assurance and quality control systems through
p.(None): standard operating procedures, to ensure that conducting a clinical trial, obtaining
p.(None): data, documentation and reporting are in accordance with the Protocol, Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 5.1.2. The sponsor is responsible for contracting with all parties involved to ensure direct access
p.(None): (see 1.21.) all test centers, original data / documents and
p.(None): reports, for the purpose of monitoring and referral by the sponsor and domestic or foreign inspection.
p.(None): 5.1.3. Quality control should be carried out at all levels of data handling in order to ensure their quality
p.(None): reliability and proper processing.
p.(None): 5.1.4. Contracts concluded between sponsors and researchers / institution and other parties
p.(None): those involved in the clinical trial should be in writing as an integral part of the Protocol or as
p.(None): special contract.
p.(None): 5.2. Contracting research organization
p.(None): 5.2.1. The sponsor may delegate all of its obligations or functions or part thereof to a contract research agent
p.(None): organization, but the ultimate responsibility for the quality and integrity of the test results is always borne by the sponsor. Contractual
p.(None): the research organization should meet the requirements of quality assurance and control.
p.(None): 5.2.2. Any obligation and function in connection with the examination, which is delegated and accepted by the contracting authority
p.(None): research organizations, should be stated in writing.
p.(None): 5.2.3. Any examination obligation and function not specifically delegated and accepted by
p.(None): contract research organization, retains sponsor.
p.(None): 5.2.4. Anything in these guidelines that applies to the sponsor applies to the contracting research organization in that sponsor
p.(None): the extent to which the contracting research organization has assumed obligations and functions from the sponsor in relation to
p.(None): by conducting a clinical trial.
p.(None): 5.3. Professional doctoral opinion
...
p.(None): testing.
p.(None): 5.4.2. Explanations regarding the Protocol and amendments to the Protocol are provided in Chapter 6, "ICH"
p.(None): Guidelines for the structure and content of clinical trial reports and other "ICH" guidelines
p.(None): related to test planning, protocol development and testing.
p.(None): 5.5. Test management, data handling and record keeping
p.(None): 5.5.1. The sponsor should appoint appropriately qualified staff to oversee the whole
p.(None): conducting tests, for handling data, for validating data, for conducting statistical analysis
p.(None): and preparing test reports.
p.(None): 5.5.2. The sponsor may set up independent monitoring committees to periodically evaluate progress
p.(None): clinical trial, including safety data and critical conclusions on drug efficacy, and for recommendation
p.(None): to the sponsor whether to continue, modify, or terminate the examination. An independent commission should have written documents
p.(None): standard operating procedures and to keep written records of all its meetings.
p.(None): 5.5.3. When the test uses electronic data management, that is, a remote electronic system, the sponsor
p.(None): should:
p.(None): a) ensure and document the compliance of the electronic data processing system with the requirements
p.(None): sponsors for completeness, accuracy, reliability and consistency of processing, ie. validation;
p.(None): b) maintain standard operating procedures for the use of these systems;
p.(None): c) Provide a system that enables the data to be modified in such a way that each change is recorded and
p.(None): that there is no possibility of deleting the entered data (ie maintaining the transparency of the test data);
p.(None): d) provide a security system that prevents unauthorized access to data;
p.(None): e) maintain a list of persons authorized to change the information (see 4.1.5 and 4.9.3);
p.(None): f) maintain adequate data protection;
p.(None): g) Preserve masking, if any (eg when entering and processing data).
p.(None): 5.5.4. If data is transformed during its processing, it should always be left behind
p.(None): ability to compare original data with transformed data.
p.(None): 5.5.5. Sponsor should use unambiguous code to identify respondents (see 1.58.)
p.(None): which allows identification of all reported data for each respondent.
p.(None): 5.5.6. The sponsor or other data owners should keep all their basic documents concerning the sponsor in the
p.(None): related to the trial (see 8. Basic documents for conducting the clinical trial).
p.(None): 5.5.7. These documents should be kept by the sponsor in accordance with the applicable laws of the countries in which they are located
p.(None): a product approved for placing on the market and / or in the countries where it intends to apply for it
p.(None): approval.
p.(None): 5.5.8. If the sponsor interrupts the clinical development of the product under study (ie for some or all indications, the route of administration
p.(None): or dosage form) should retain all of its basic documents for at least two years from its formal termination
p.(None): tests or in accordance with applicable legal regulations.
p.(None): 5.5.9. If the sponsor interrupts the clinical development of the product under investigation, everyone should be informed
p.(None): researchers / institutions and all competent authorities.
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p.(None): 5.5.10. Any transfer of ownership of the data should be reported to the appropriate authorities, in accordance with the applicable ones
p.(None): legal regulations.
...
p.(None): Observe during testing, handling and storage of the product under test and related documentation. These
p.(None): instructions should include proper and secure admission, handling, storage and dispensing of the subject
p.(None): product, downloading unused test product from respondent and returning it to the sponsor (ie
p.(None): another way to remove unused product if approved by the sponsor, in accordance with applicable law
p.(None): regulations).
p.(None): 5.14.4. The sponsor should:
p.(None): a) ensure timely delivery of the test product to the researcher;
p.(None): b) keep records of the transport, receipt, disposal, return and destruction of the product under test (see
p.(None): 8. Basic documents for conducting the clinical trial);
p.(None): c) provide for a system of return for the product under examination and for recording such a download (e.g.
p.(None): for recall of defective products, returns upon completion of tests, refunds after expiration
p.(None): duration);
p.(None): d) maintains a system for withdrawing unused test product and recording it
p.(None): withdrawals.
p.(None): 5.14.5. The sponsor should:
p.(None): a) take the necessary measures to ensure the stability of the product under test during the period of use;
p.(None): b) have sufficient quantities of the product under test for subsequent confirmation
p.(None): its specifications, if necessary, and keeps the documentation of the analysis and
p.(None): characteristics of the production batch sample. To the extent permitted by the stability of the drug, samples should be kept at or up to
p.(None): completing the analysis of the test results or by the deadline prescribed by applicable law, if required
p.(None): and a longer storage period.
p.(None): 5.15. Access to documentation
p.(None): 5.15.1. The sponsor should ensure that the Protocol or other written agreement states that
p.(None): the researcher / institution must allow direct access to the original data / documents
p.(None): for monitoring, audit, review by the Ethics Committee and inspection by the competent authorities.
p.(None): 5.15.2. The sponsor should determine that each respondent has given his / her written consent for direct access to his / her own
p.(None): original health data for monitoring, audit, review by the Ethics Committee and inspection by
p.(None): by the competent authorities.
p.(None): 5.16. Security information
p.(None): 5.16.1. The sponsor is responsible for the ongoing assessment of the safety of the product being tested.
p.(None): 5.16.2. The sponsor should promptly inform all researchers / institutions and competent authorities of
p.(None): knowledge that may adversely affect the safety of the respondent, the conduct of the examination, or the modification
p.(None): approval / positive opinion of the Ethics Committee.
p.(None): 5.17. Reporting adverse drug reactions
p.(None): 5.17.1. The sponsor should promptly inform all researchers / institutions, Ethics Committees (where applicable)
p.(None): necessary) and the competent authorities of any serious and unexpected adverse reactions to the drug.
p.(None): 5.17.2. These emergency reports should comply with applicable laws and "ICH"
p.(None): Clinical Safety Information Management Guidelines: Definitions and Standards for Urgent Reporting.
p.(None): 5.17.3. The sponsor should submit to the competent authorities all updated and periodic safety reports,
p.(None): in accordance with applicable law.
p.(None): 5.18. Monitoring
p.(None): 5.18.1. Purpose
p.(None): The purpose of monitoring the test is to confirm:
...
p.(None): When conducting an audit, which is part of quality assurance, the sponsor should consider the following:
p.(None): 5.19.1. Purpose gone
p.(None): The purpose of the sponsor's departure, which is independent and separate from routine monitoring and quality control,
p.(None): should be an assessment of the conduct of testing and adherence to the Protocol, standard operating
p.(None): procedures, Good Clinical Practices and applicable law.
p.(None): 5.19.2. Choice and qualifications of the auditor
p.(None): a) The sponsor should appoint persons who are independent of the clinical trial, respectively, to conduct the audit
p.(None): system.
p.(None): b) The sponsor should ensure that the auditors are qualified by practice and experience for
p.(None): conducting odits properly. Auditor qualifications should be documented.
p.(None): 5.19.3. Departure procedures
p.(None): a) The sponsor should ensure that the clinical trial data and procedures are followed in accordance with
p.(None): the sponsor's written procedures on what and how it should be monitored, how often and in what form and content
p.(None): there should be surveillance reports.
p.(None): b) The sponsor's plan and test procedures should be based on the importance of the test planned for
p.(None): submission to the competent authorities, number of respondents, type and complexity of examination, level of risk for
p.(None): respondents and any other perceived problems.
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p.(None): c) Observer observations and findings should be documented.
p.(None): d) In order to safeguard the independence and importance of the odit function, competent authorities need not routinely seek it
p.(None): odita reports. Competent authorities may request access to the individual audit report
p.(None): cases where there is evidence of a serious deviation from Good Clinical Practice, that is, during the trial
p.(None): procedure.
p.(None): e) When provided by applicable law or regulations, the sponsor is required to submit a certificate of completion
p.(None): oditu.
p.(None): 5.20. Mismatch
p.(None): 5.20.1. In case of non-adherence to the Protocol, standard operating procedures, good clinical practice
p.(None): and / or applicable legislation by the researcher / institution or member of the sponsor's team, the sponsor should
p.(None): to take urgent measures to ensure compliance.
p.(None): 5.20.2. If the monitoring and / or departure process establishes a serious and / or permanent deviation from
p.(None): plan by the researcher / institution, the sponsor should terminate his participation in the
p.(None): examination. When the participation of the researcher / institution is terminated due to discrepancies, the sponsor shall do so
p.(None): it must immediately inform the competent authorities.
p.(None): 5.21. Premature completion or delay of clinical trial
p.(None): If the examination is interrupted or delayed, the sponsor should immediately inform the researcher / institution
p.(None): and the competent authorities and give reasons for termination or delay. Also, sponsor or researcher / institution, depending on
p.(None): current legislation, you should immediately notify the Ethics Committee and provide reasons for termination or adjournment.
p.(None): 5.22. Clinical trial reports
p.(None): Whether the examination is completed or terminated, the sponsor should ensure that a report is prepared and submitted
p.(None): clinical trial to competent authorities in accordance with applicable legal requirements. The sponsor should also provide
...
p.(None): 6.6.3. Procedures for monitoring compliance with the test plan by the respondent.
p.(None): 6.7. Evaluation of efficiency
p.(None): 6.7.1. Determination of efficiency parameters.
p.(None): 6.7.2. Methods and timeframe for estimating, recording and analyzing efficiency parameters.
p.(None): 6.8. Security assessment
p.(None): 6.8.1. Determining security parameters.
p.(None): 6.8.2. Methods and time period for estimating, recording and analyzing security parameters.
p.(None): 6.8.3. Procedures for recording and reporting adverse events and associated diseases.
p.(None): 6.8.4. The manner and length of the follow-up period of the respondent after an adverse event.
p.(None): 6.9. Statistical data
p.(None): 6.9.1. A description of the statistical methods that will be applied, including the time for any planned
p.(None): interanalysis.
p.(None): 6.9.2. Number of planned respondents. In multicenter trials, the planned number should be indicated
p.(None): respondents for each testing center. Reason for choosing a specific sample size (number
p.(None): subjects), including the impact on the significance of the trial and its clinical justification.
p.(None): 6.9.3. The degree of significance that will be used.
p.(None): 6.9.4. Criteria for completing the test.
p.(None): 6.9.5. Procedures for explaining gaps, unused or false information.
p.(None): 6.9.6. Procedures for reporting deviations from the original statistical plan (any
p.(None): deviation from the original statistical plan should be described and explained in the Protocol and / or final
p.(None): report).
p.(None): 6.9.7. Selection of respondents to be included in the analyzes (eg all randomized, received subjects
p.(None): drug tested, eligible subjects, evaluable subjects).
p.(None): 6.10. Direct access to original data / documents The sponsor should ensure that it is in the Protocol or another
p.(None): indicate in the written document that the researcher / institution will allow monitoring and departure, considered by the Ethical
p.(None): board and inspection by the competent authorities, by allowing access to the original
p.(None): data / documents.
p.(None): 6.11. Quality assurance and quality control
p.(None): 6.12. Ethical aspects of testing
p.(None): Description of ethical considerations related to clinical trial.
p.(None): 6.13. Handling data and keeping records
p.(None): 6.14. Financing and insurance
p.(None): The method of financing and insurance should be indicated only if they are not specified in a separate contract.
p.(None): 6.15. Publication policy
p.(None): The agreement to publish the test results should be stated only if they are not specified in a separate contract.
p.(None): 6.16. Extras
p.(None): (Note: Given that the Protocol and clinical trial / study report are very close,
p.(None): additional information can be found in the "ICH" Guidelines for the structure and content of clinical trial reports.)
p.(None): 7. RESEARCH BROCHURE
p.(None): 7.1. Introduction
p.(None): The Researcher's Brochure is a collection of clinical and preclinical data on the product under study that is important
p.(None): for testing it on humans. Its purpose is to provide researchers and other persons involved in
p.(None): examination of information that facilitates understanding and facilitates adherence to the Clinical Protocol
p.(None): tests, clarify many protocol items such as dosage, dosage regimen, route of administration, and control procedures
p.(None): test security. The Researcher's Brochure also provides insights into the clinical processing of subjects throughout
p.(None): clinical trial. Avoiding product promotion, information should be presented in a concise, simple,
p.(None): an objective and balanced manner that enables the clinician or researcher to understand fully and independently
p.(None): making an objective assessment of the propriety of the proposed examination based on the assessment of the relationship
...
p.(None): - test sheets
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Ads to include respondents (if planned
p.(None): of the said documents in the examination
p.(None): TESTING
p.(None): - letters / letters
p.(None): - meeting notes
p.(None): - telephone conversation notes
p.(None): 3/8/12 SIGNED
p.(None): the provisions of the Protocol,
p.(None): conducting tests, reporting adverse events
p.(None): Document that X
p.(None): advertising)
p.(None): 8.3.3. DATED AND DOCUMENTED APPROVAL / POSITIVE OPINION OF ETHICAL
p.(None): Document X changes and / or additions
p.(None): reviewed and discussed by the Ethics Committee
p.(None): INFORMED CONSTITUENTS respondent gave his
p.(None): X consent in accordance with
p.(None): Good clinical practice and the Protocol before his
p.(None): COMMITTEES ON THE FOLLOWING: Adopted positively
p.(None): opinion. Identify the number, version and date of each document
p.(None): - Protocol modifications and additions
p.(None): - changes:
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Respondent engagement ads (if scheduled)
p.(None): - other approved documents
p.(None): - test monitoring reports (where applicable)
p.(None): 8.3.4. LICENSE / APPLICATION Document
p.(None): X (if X
p.(None): 3/8/13 ORIGINAL DOCUMENTS
p.(None): 3/8/14 COMPLETED, SIGNED AND DATED TEST SHEETS
p.(None): engaging in testing. In addition document the permission for direct access to the data (see 8.2.3.)
p.(None): Document the existence of the interviewee and prove the integrity of the collected test data, including the original
p.(None): documents related to examination, treatment and medical history
p.(None): Document that the researcher or an authorized member of the research team has verified the information in the test list
p.(None): X
p.(None): X (copy)
p.(None): X
p.(None): (original)
p.(None): THE COMPETENT AUTHORITY, WHERE REQUIRED, TO:
p.(None): - amendments to the protocols and other documents
p.(None): compliance with applicable legislation
p.(None): needed)
p.(None): 3/8/15 DOCUMENTATION Document everything
p.(None): ON THE TEST LIST AMENDMENTS, respectively
p.(None): corrections to the test list after entering the initial data, as well as being signed and dated
p.(None): X (copy) X (original)
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p.(None): Monday, March 12, 2012
p.(None): 3/8/16 NOTICE OF SERIOUS ADVERSE EVENTS AND
p.(None): Document X
p.(None): notification of the researcher to the sponsor of serious
p.(None): X 8.4. After completion or termination of testing
p.(None): Upon completion or termination of the test, all documentation referred to in sections 8.2. and 8.3. should be guarded,
p.(None): as well as
p.(None): ASSOCIATED REPORTS TO ADVERSE EVENTS i
p.(None): WHICH THE RESEARCH SUPPLIES TO THE SPONSOR
p.(None): 3/8/17 NOTICE
p.(None): related reports in accordance with 4.11.
p.(None): Document
p.(None): X (if X
p.(None): the following documents:
p.(None): Document Title Purpose Researcher / Institution
p.(None): Sponsor
p.(None): SPONSOR / RESEARCH notification
p.(None): needed)
p.(None): 8.4.1. RECORD
p.(None): Document that X X
p.(None): ABOUT THE unexpected unexpected unwanted
p.(None): sponsors / researchers to the competent authorities,
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p.(None): and the local and systemic bioavailability of the test product and its metabolites as well as their own
p.(None): correlation with pharmacological and toxicological findings from animal species experiments.
p.(None): (3) Toxicology
p.(None): The summary should describe the toxic effects from significant studies carried out on different animal species, namely
p.(None): that it contains the following:
p.(None): - single dose;
p.(None): - repeated dose;
p.(None): - carcinogenicity;
p.(None): - special tests (eg irritation and sensitization);
p.(None): - reproductive toxicology;
p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
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p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
p.(None): metabolism, if necessary), as well as information on the dose dependence of the effect obtained from earlier studies
p.(None): tests in humans (healthy volunteers and / or patients). The significance of this data should be considered. Where it is
p.(None): completed multiple clinical trials, review summaries of safety findings and
p.(None): efficacy by indication or subgroup can give a clear view of the data. Together
p.(None): a tabular summary of adverse reactions to the product under study (for all indications tested) can be very significant.
p.(None): Significant differences in adverse reactions to the indications and subgroups of subjects should be considered.
p.(None): The booklet for the researcher should describe the possible risks and side effects of the drug on the basis
p.(None): previous experience with the product tested and related drugs. Warnings and specials should also be mentioned
p.(None): measures as an integral part of the application of the test product.
p.(None): (3) Experiences after placing the test product on the market The Brochure should indicate the countries where it is
p.(None): interrogated
p.(None): the product has been granted marketing authorization. A summary of all relevant information obtained from
...
Social / Elderly
Searching for indicator elderly:
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p.(None): testing.
p.(None): 1.56. Podistraživač
p.(None): Each individual member of the clinical trial team is appointed and supervised by
p.(None): investigator at the test center to perform key activities in the clinical trial and / or for
p.(None): clinical trial decision making (eg associates, specialists, research associates).
p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
...
Social / Ethnicity
Searching for indicator ethnic:
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p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): an impartial witness present. After the respondent or his legal representative is read
p.(None): a written consent form and other written notice intended for the respondents, and after the respondent
p.(None): or his legal representative orally consent to the respondent's participation in the examination, the respondent personally
p.(None): sign and date a written consent form, if capable, and also an impartial witness.
p.(None): By signing the written consent form, the witness confirms that the information on the form and other information is correct
p.(None): explained to the respondent or his legal representative that they were clear and that according to his
p.(None): assessment, the respondent or his legal representative understood and voluntarily gave his or her consent.
p.(None): 4.8.10. Consent interview, consent form and other written notices intended
p.(None): respondents should include the following explanations:
p.(None): a) the clinical trial is of a research nature;
p.(None): b) the objective of the examination;
p.(None): c) the therapy being tested and the possibility of accidental inclusion in one of the treatment groups;
p.(None): d) the procedures provided for in the test, including invasive procedures;
p.(None): e) Respondents' duties;
p.(None): f) experimental aspects of testing;
p.(None): g) the foreseeable risks and inconveniences for the respondent, ie embryo, fetus or infant;
p.(None): h) benefits that can be expected. When no clinical benefit is expected for the respondent,
p.(None): he must be warned;
p.(None): i) alternative therapeutic procedures and / or treatment options available to the respondent at
p.(None): the availability and their potential risks and benefits;
p.(None): j) compensation and / or treatment provided to the respondent in case of injury caused by the examination;
p.(None): k) the estimated schedule of payment of installments of any compensation to the respondents for participation in the examination;
p.(None): l) any other costs foreseen for the respondent to participate in the examination;
p.(None): m) that the respondent's participation in the examination is voluntary and that the respondent may leave at any time
p.(None): that is, to interrupt the examination without suffering any consequences of its decision;
p.(None): n) that the monitor, the auditor, the Ethics Committee and the competent authorities will have direct access to the original healthcare
p.(None): the data of the subjects for the purpose of verifying the procedures, ie obtained data in the clinical trial, with full protection
p.(None): secrecy of the respondent's identity within the limits of the applicable laws and regulations, as well as that of the respondent or his
p.(None): the legal representative permits such access to the data by signing informed consent;
p.(None): o) that the personal data of the respondents will be confidential and that, within the limits of the applicable laws and / or
...
Social / Homeless Persons
Searching for indicator homeless:
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p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
p.(None): experience to perform their tasks.
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): - requires or extends existing hospitalization,
p.(None): - permanent or significant disability or disability,
p.(None): - congenital anomalies, that is, a birth defect.
p.(None): 1.51. Original data
p.(None): Original medical records from original documents and certified copies of original clinical and laboratory records
p.(None): findings or other results of activities performed during the clinical trial that are required for
p.(None): evaluation of test results.
p.(None): The original information is contained in the original documentation (as originals or certified copies).
p.(None): 1.52. Original documentation
p.(None): Source documents, data and records (e.g., medical history, clinical and administrative records,
p.(None): laboratory findings, memos, subjects' diaries or test lists, drug dispensing records, recorded
p.(None): automated device data, copies and transcripts verified after authentication, negatives,
p.(None): microfilms and magnetic recordings, x-rays, pharmacy records, laboratories and
p.(None): medical-technical services involved in the clinical trial).
p.(None): 1.53. Sponsor
p.(None): Individual or legal entity responsible for initiating, conducting and / or financing a clinical
p.(None): testing.
p.(None): 1.54. Sponsor - Researcher
p.(None): An individual who initiates and conducts a clinical trial, alone or with others, and under whose immediate supervision
p.(None): the test product is prescribed, dispensed, or applied by the respondent. This one
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 53
p.(None): the term is restricted to natural persons (ie does not include legal persons such as corporations or agencies).
p.(None): The duties of sponsor - researcher are combined the duties of sponsor and researcher
p.(None): 1.55. Standard Operating Procedures ("SOPs")
p.(None): Detailed written instructions for achieving uniformity in performing all clinical procedures
p.(None): testing.
p.(None): 1.56. Podistraživač
p.(None): Each individual member of the clinical trial team is appointed and supervised by
p.(None): investigator at the test center to perform key activities in the clinical trial and / or for
p.(None): clinical trial decision making (eg associates, specialists, research associates).
p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
...
Social / Infant
Searching for indicator infant:
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p.(None): a written consent form and other written notice intended for the respondents, and after the respondent
p.(None): or his legal representative orally consent to the respondent's participation in the examination, the respondent personally
p.(None): sign and date a written consent form, if capable, and also an impartial witness.
p.(None): By signing the written consent form, the witness confirms that the information on the form and other information is correct
p.(None): explained to the respondent or his legal representative that they were clear and that according to his
p.(None): assessment, the respondent or his legal representative understood and voluntarily gave his or her consent.
p.(None): 4.8.10. Consent interview, consent form and other written notices intended
p.(None): respondents should include the following explanations:
p.(None): a) the clinical trial is of a research nature;
p.(None): b) the objective of the examination;
p.(None): c) the therapy being tested and the possibility of accidental inclusion in one of the treatment groups;
p.(None): d) the procedures provided for in the test, including invasive procedures;
p.(None): e) Respondents' duties;
p.(None): f) experimental aspects of testing;
p.(None): g) the foreseeable risks and inconveniences for the respondent, ie embryo, fetus or infant;
p.(None): h) benefits that can be expected. When no clinical benefit is expected for the respondent,
p.(None): he must be warned;
p.(None): i) alternative therapeutic procedures and / or treatment options available to the respondent at
p.(None): the availability and their potential risks and benefits;
p.(None): j) compensation and / or treatment provided to the respondent in case of injury caused by the examination;
p.(None): k) the estimated schedule of payment of installments of any compensation to the respondents for participation in the examination;
p.(None): l) any other costs foreseen for the respondent to participate in the examination;
p.(None): m) that the respondent's participation in the examination is voluntary and that the respondent may leave at any time
p.(None): that is, to interrupt the examination without suffering any consequences of its decision;
p.(None): n) that the monitor, the auditor, the Ethics Committee and the competent authorities will have direct access to the original healthcare
p.(None): the data of the subjects for the purpose of verifying the procedures, ie obtained data in the clinical trial, with full protection
p.(None): secrecy of the respondent's identity within the limits of the applicable laws and regulations, as well as that of the respondent or his
p.(None): the legal representative permits such access to the data by signing informed consent;
p.(None): o) that the personal data of the respondents will be confidential and that, within the limits of the applicable laws and / or
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): examinations, the researcher should have the written approval / positive opinion of the Ethics Committee on the written form
p.(None): consent to other written notices intended for the respondents.
p.(None): 4.8.2. The written consent form of the respondents and all other written information intended for the respondents should be provided
p.(None): amendments after each new information that might affect the consent of the respondents. Before application,
p.(None): Amended respondent consent form and other written notice intended
p.(None): respondents should be approved / approved by the Ethics Committee. Respondent respectively his / her legal
p.(None): the deputy should be informed in good time of any new information that may influence the decision
p.(None): respondents to continue participation in the examination. Information on this shall be kept in writing.
p.(None): 4.8.3. Neither the researcher nor the staff participating in the test shall coerce or inappropriately influence
p.(None): respondents to participate in, or continue to participate in, the examination.
p.(None): 4.8.4. None of the oral and written examination-related information, including consent form
p.(None): respondents should not be written in a language that would deprive the respondent or his legal representative
p.(None): any legal right, or by which the researcher, institution, sponsor or his representative would be exonerated
p.(None): liability for negligence.
p.(None): 4.8.5. The researcher or the person designated by the researcher should inform the respondent, that is, his / her legal
p.(None): if the respondent is not competent to give consent, on all aspects of the examination, including written notices
p.(None): for which approval / positive opinion of the Ethics Committee has been obtained.
p.(None): 4.8.6. Language used in oral and written examination notices, including
p.(None): the respondent's consent form should not contain expert terminology but should be understandable to the respondent
p.(None): that is, his legal representative and impartial witness.
p.(None): 4.8.7. Before obtaining consent, the researcher or the person appointed by the researcher should provide
p.(None): respondent or his / her legal representative sufficient time and opportunity to find out details about
p.(None): examination to decide whether or not to participate in it. All questions related to the examination should
p.(None): to answer until the respondent or his legal representative is satisfied with them.
p.(None): 4.8.8. The written consent form must be signed and dated before the interviewee is included in the examination
p.(None): by the respondent or his legal representative, also signed by the person who
p.(None): interviewed the respondent / legal representative.
p.(None): 4.8.9. If the respondent or his legal representative cannot read, there must be throughout the interview
p.(None): an impartial witness present. After the respondent or his legal representative is read
p.(None): a written consent form and other written notice intended for the respondents, and after the respondent
p.(None): or his legal representative orally consent to the respondent's participation in the examination, the respondent personally
p.(None): sign and date a written consent form, if capable, and also an impartial witness.
...
Social / Marital Status
Searching for indicator single:
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p.(None): No. 19 - Page 50 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 8.4.2. DOCUMENTATION ON THE DESTRUCTION OF THE TESTED PRODUCT
p.(None): 8.4.3. LISTA SA
p.(None): respondents, how much was returned to the sponsor Document destruction
p.(None): unused tested products at the testing center or sponsored
p.(None): Enable
p.(None): X (if X
p.(None): destroyed at the site of the test)
p.(None): X
p.(None): tests performed on humans. Complying with these standards gives the public confidence that they are
p.(None): the rights, safety and well-being of the respondents are protected and in accordance with the principles arising from the Declaration of Helsinki, and
p.(None): that the information obtained from the clinical trial is credible.
p.(None): The aim of these Good Clinical Practice Guidelines is to provide a single standard for the European Union
p.(None): (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by
p.(None): by the competent authorities of those
p.(None): IDENTIFICATION IDENTIFICATION
p.(None): countries.
p.(None): CODE OF RESPONDENTS
p.(None): of all respondents who participated in the examination for the purpose of monitoring them. The list should be kept confidential at
p.(None): the agreed time period
p.(None): The guidelines have been developed taking into account the applicable principles of good clinical practice in the European Union, Japan and
p.(None): The United States, but also Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
p.(None): These guidelines should be followed when analyzing clinical trial data at the time of submission
p.(None): requests to the competent authorities.
p.(None): The principles set out in these Guidelines may also apply
p.(None): 8.4.4. WITNESS CERTIFICATE Document that X
p.(None): (where available)
p.(None): 8.4.5. FINAL
p.(None): is odit performed Document yes
p.(None): in other clinical trials that may affect safety
p.(None): X and respondent welfare.
p.(None): MONITOR REPORT are all activities in
p.(None): 1. DEFINITIONS
p.(None): ABOUT TESTING COMPLETION
p.(None): 8.4.6. THERAPY GROUPS AND DECISION DOCUMENTATION
p.(None): 8.4.7. FINAL REPORT OF THE RESEARCHER TO THE ETHICAL COMMITTEE AND / OR THE COMPETENT AUTHORITIES
p.(None): 8.4.8. CLINICAL TESTING FINAL REPORT
p.(None): 9. PUBLISHING
p.(None): examination completed, and copies of basic documents kept in appropriate records
p.(None): Returns to the sponsor to document any decryption procedures
p.(None): Document completion of testing
...
p.(None): (Official Gazette of BiH, No. 58/08), Expert Council of the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.(None): Herzegovina, at the 13th session held on 17.11.2011. at the proposal of the Director of the Agency for Medicinal Products and
p.(None): medical devices of Bosnia and Herzegovina, brings
p.(None): GUIDELINES
p.(None): GOOD CLINICAL PRACTICES IN CLINICAL TESTING
p.(None): INTRODUCTION
p.(None): Good clinical practice (GCP) represents international ethical and scientific
p.(None): quality standards for planning, implementing, monitoring and reporting on
p.(None): Positive decision of the Ethics Committee on clinical trial that it can be conducted at the trial center in accordance with
p.(None): provisions of this committee, institution, Good Clinical Practice and applicable law.
p.(None): 1.6. Odit
p.(None): Systematic and independent review of clinical trial activities and documents to determine if
p.(None): examination conducted, data entered and analyzed and reported in accordance with the Protocol,
p.(None): sponsor standard operating procedures (SOPs), Good Clinical Practice and applicable legal requirements.
p.(None): 1.7. Certificate of Completion
p.(None): A statement confirming that the odit was performed.
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 51
p.(None): 1.8. Departure report
p.(None): Auditor's written report on the results of the audit.
p.(None): 1.9. The documentation is gone
p.(None): Documentation allowing monitoring of the course of the clinical trial.
p.(None): 1.10. Clinical trial blindness / masking
p.(None): A process to ensure that one or more parties participating in a clinical trial do not have insight into
p.(None): the respondents' belonging to the treatment groups. A single blind examination means that the respondent,
p.(None): that is, respondents have no insight into belonging to treatment groups, and double-blind to insight into belonging
p.(None): The treatment groups do not have a respondent, ie respondents, a researcher, a monitor, and in some cases, an analyst
p.(None): data.
p.(None): 1.11. Test list
p.(None): Printed, optical or electronic document intended to record all data required by the Protocol
p.(None): a clinical trial reporting the sponsor to each subject.
p.(None): 1.12. Clinical trial
p.(None): Any human test intended to detect or confirm clinical, pharmacological and / or
p.(None): pharmacodynamic effects of the test product and / or adverse reaction identification and / or testing
p.(None): resorption, distribution, metabolism and excretion, with the aim of determining safety and / or efficacy
p.(None): of the tested product.
p.(None): 1.13. Clinical trial report
p.(None): Document a complete clinical trial of any therapeutic, prophylactic or diagnostic efficacy
p.(None): of the drug, which summarizes clinically and statistically significant data, findings and analyzes obtained
p.(None): test results. (see "ICH" Guidelines for the Structure and Content of the Clinical Report
p.(None): examination).
p.(None): 1.14. Comparative product
p.(None): Tested or marketed product (i.e. active control) or placebo to compare drug / medical
p.(None): the product being clinically tested.
p.(None): 1.15. Compliance with the adopted clinical trial plan
p.(None): Compliance with all clinical trial requirements, Good Clinical Practice and applicable legal requirements.
p.(None): 1.16. Confidentiality
...
p.(None): In the sections below, the most important results of the preclinical trials, including those observed, should be considered
p.(None): effects at administered doses, relevance to human administration, and other aspects to be studied
p.(None): people. If possible, the results of administering effective and non-toxic doses for the same species should be compared
p.(None): animals (e.g. consider therapeutic index). The importance of all data in the planning of dosing should be considered
p.(None): in humans. Whenever possible, the dosage should be based on blood / tissue levels, not mg / kg.
p.(None): (1) Preclinical pharmacology
p.(None): A summary of the pharmacological aspects of the product under study and significant metabolic studies should be provided
p.(None): to animals, where it exists. Such summary should include tests where possible
p.(None): therapeutic effect of the drug (eg mode of action, receptor binding and specificity) and its
p.(None): safety (eg special studies of pharmacological effects other than therapeutic).
p.(None): (2) Pharmacokinetics and metabolism of the test product in animals
p.(None): The pharmacokinetics, biotransformation and distribution of the test product in all animals should be summarized
p.(None): who have undergone preclinical research. Resorption should be considered when considering the results
p.(None): and the local and systemic bioavailability of the test product and its metabolites as well as their own
p.(None): correlation with pharmacological and toxicological findings from animal species experiments.
p.(None): (3) Toxicology
p.(None): The summary should describe the toxic effects from significant studies carried out on different animal species, namely
p.(None): that it contains the following:
p.(None): - single dose;
p.(None): - repeated dose;
p.(None): - carcinogenicity;
p.(None): - special tests (eg irritation and sensitization);
p.(None): - reproductive toxicology;
p.(None): - genotoxicity (mutagenicity).
p.(None): 7.3.6. Acting in humans
p.(None): The known effects of the test product in humans, including data, should be specified
p.(None): about his
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 65
p.(None): pharmacokinetics, metabolism, pharmacodynamics, dose / effect ratio, safety, efficacy and other
p.(None): pharmacological actions. Wherever possible, a summary of all completed clinical trials should be provided.
p.(None): Also, information regarding the use of the test product outside the clinical should be provided
p.(None): tests, such as post-marketing experience.
p.(None): (1) Pharmacokinetics and metabolism of the test product in humans
p.(None): If available, they should be included in the summary of the pharmacokinetics of the test product
p.(None): the following:
p.(None): pharmacokinetics (including metabolism and resorption, binding to plasma proteins, distribution
p.(None): and elimination);
p.(None): - bioavailability of the test product (absolute and relative, if possible) for different doses
p.(None): forms;
p.(None): - Population subgroups (eg by sex, age and impaired organ function);
p.(None): - interactions (eg drug interactions and the impact of food);
p.(None): - other pharmacokinetic data (eg clinical trial results
p.(None): for different population groups).
p.(None): (2) Safety and efficiency
p.(None): A summary of the data on safety, pharmacodynamics, efficacy (i
...
Social / Police Officer
Searching for indicator police:
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p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
...
Social / Presence of Coercion
Searching for indicator coerce:
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p.(None): Issue 19 - Page 56 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 4.8.1. In the process of obtaining and recording the consent of the respondents, the researcher should adhere to the valid ones
p.(None): legislation, good clinical practice and ethical principles stemming from the Declaration of Helsinki. Before you begin
p.(None): examinations, the researcher should have the written approval / positive opinion of the Ethics Committee on the written form
p.(None): consent to other written notices intended for the respondents.
p.(None): 4.8.2. The written consent form of the respondents and all other written information intended for the respondents should be provided
p.(None): amendments after each new information that might affect the consent of the respondents. Before application,
p.(None): Amended respondent consent form and other written notice intended
p.(None): respondents should be approved / approved by the Ethics Committee. Respondent respectively his / her legal
p.(None): the deputy should be informed in good time of any new information that may influence the decision
p.(None): respondents to continue participation in the examination. Information on this shall be kept in writing.
p.(None): 4.8.3. Neither the researcher nor the staff participating in the test shall coerce or inappropriately influence
p.(None): respondents to participate in, or continue to participate in, the examination.
p.(None): 4.8.4. None of the oral and written examination-related information, including consent form
p.(None): respondents should not be written in a language that would deprive the respondent or his legal representative
p.(None): any legal right, or by which the researcher, institution, sponsor or his representative would be exonerated
p.(None): liability for negligence.
p.(None): 4.8.5. The researcher or the person designated by the researcher should inform the respondent, that is, his / her legal
p.(None): if the respondent is not competent to give consent, on all aspects of the examination, including written notices
p.(None): for which approval / positive opinion of the Ethics Committee has been obtained.
p.(None): 4.8.6. Language used in oral and written examination notices, including
p.(None): the respondent's consent form should not contain expert terminology but should be understandable to the respondent
p.(None): that is, his legal representative and impartial witness.
p.(None): 4.8.7. Before obtaining consent, the researcher or the person appointed by the researcher should provide
p.(None): respondent or his / her legal representative sufficient time and opportunity to find out details about
...
Social / Soldier
Searching for indicator military:
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p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.(None): 1.43. Original health information
p.(None): See Original data.
p.(None): 1.44. Clinical trial protocol
p.(None): Document describing the objectives, plan, test methodology, method of statistical data processing and
p.(None): organization of testing. The protocol usually contains either an introduction and a rational basis for testing or this may
p.(None): be described by a protocol amendment.
p.(None): 1.45. Changes and additions to the Clinical Trial Protocol
p.(None): Description of the modification of the Clinical Trial Protocol in writing, or its official explanation.
p.(None): 1.46. Quality assurance
p.(None): All planned and systematic activities aimed at ensuring consistency of implementation
p.(None): clinical trial, documenting results and reporting with Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 1.47. Quality control
p.(None): Operational techniques and quality assurance activities aimed at verifying that they are
p.(None): all the quality requirements related to the test are met.
p.(None): 1.48. Randomization
p.(None): The process of randomly selecting (classifying) subjects into a therapeutic or control group, thereby reducing it
p.(None): researcher bias.
p.(None): 1.49. Competent authorities
p.(None): Bodies competent for the adoption of legislation. For the purposes of these guidelines, the term competent authorities includes bodies which
p.(None): have the regulatory power to legislate including review a submitted clinical
p.(None): documentation and inspection (see 1.29).
p.(None): 1.50. Serious adverse event or serious adverse reaction
p.(None): Any undesirable medical phenomenon related to the health of the subjects causing at any dose:
p.(None): - death,
p.(None): - Immediate threat to life,
p.(None): - requires or extends existing hospitalization,
p.(None): - permanent or significant disability or disability,
p.(None): - congenital anomalies, that is, a birth defect.
p.(None): 1.51. Original data
p.(None): Original medical records from original documents and certified copies of original clinical and laboratory records
p.(None): findings or other results of activities performed during the clinical trial that are required for
p.(None): evaluation of test results.
p.(None): The original information is contained in the original documentation (as originals or certified copies).
p.(None): 1.52. Original documentation
p.(None): Source documents, data and records (e.g., medical history, clinical and administrative records,
p.(None): laboratory findings, memos, subjects' diaries or test lists, drug dispensing records, recorded
p.(None): automated device data, copies and transcripts verified after authentication, negatives,
p.(None): microfilms and magnetic recordings, x-rays, pharmacy records, laboratories and
p.(None): medical-technical services involved in the clinical trial).
p.(None): 1.53. Sponsor
p.(None): Individual or legal entity responsible for initiating, conducting and / or financing a clinical
p.(None): testing.
p.(None): 1.54. Sponsor - Researcher
p.(None): An individual who initiates and conducts a clinical trial, alone or with others, and under whose immediate supervision
p.(None): the test product is prescribed, dispensed, or applied by the respondent. This one
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 53
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): No. 19 - Page 50 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 8.4.2. DOCUMENTATION ON THE DESTRUCTION OF THE TESTED PRODUCT
p.(None): 8.4.3. LISTA SA
p.(None): respondents, how much was returned to the sponsor Document destruction
p.(None): unused tested products at the testing center or sponsored
p.(None): Enable
p.(None): X (if X
p.(None): destroyed at the site of the test)
p.(None): X
p.(None): tests performed on humans. Complying with these standards gives the public confidence that they are
p.(None): the rights, safety and well-being of the respondents are protected and in accordance with the principles arising from the Declaration of Helsinki, and
p.(None): that the information obtained from the clinical trial is credible.
p.(None): The aim of these Good Clinical Practice Guidelines is to provide a single standard for the European Union
p.(None): (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by
p.(None): by the competent authorities of those
p.(None): IDENTIFICATION IDENTIFICATION
p.(None): countries.
p.(None): CODE OF RESPONDENTS
p.(None): of all respondents who participated in the examination for the purpose of monitoring them. The list should be kept confidential at
p.(None): the agreed time period
p.(None): The guidelines have been developed taking into account the applicable principles of good clinical practice in the European Union, Japan and
p.(None): The United States, but also Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
p.(None): These guidelines should be followed when analyzing clinical trial data at the time of submission
p.(None): requests to the competent authorities.
p.(None): The principles set out in these Guidelines may also apply
p.(None): 8.4.4. WITNESS CERTIFICATE Document that X
p.(None): (where available)
p.(None): 8.4.5. FINAL
p.(None): is odit performed Document yes
p.(None): in other clinical trials that may affect safety
p.(None): X and respondent welfare.
p.(None): MONITOR REPORT are all activities in
p.(None): 1. DEFINITIONS
p.(None): ABOUT TESTING COMPLETION
p.(None): 8.4.6. THERAPY GROUPS AND DECISION DOCUMENTATION
p.(None): 8.4.7. FINAL REPORT OF THE RESEARCHER TO THE ETHICAL COMMITTEE AND / OR THE COMPETENT AUTHORITIES
p.(None): 8.4.8. CLINICAL TESTING FINAL REPORT
p.(None): 9. PUBLISHING
p.(None): examination completed, and copies of basic documents kept in appropriate records
p.(None): Returns to the sponsor to document any decryption procedures
p.(None): Document completion of testing
p.(None): Document test results and interpretation
p.(None): X
p.(None): X
p.(None): X X
p.(None): (if necessary)
p.(None): 1.1. Adverse drug reaction
p.(None): Any adverse and unintentionally induced drug reaction that may occur at a therapeutic dose, or
p.(None): administration of the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological
p.(None): function (see "ICH" Clinical Safety Information Management Guidelines: Definitions and Standards for Emergency
p.(None): reporting).
...
Social / Unemployment
Searching for indicator unemployed:
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p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): a quorum, in accordance with written operating procedures.
p.(None): 3.2.4. Only members of the Ethics Committee shall have the right to vote or to express opinions and / or recommendations
p.(None): committees involved in the deliberation and discussion.
p.(None): 3.2.5. Researchers may be required to provide the Ethics Committee with information on any aspect of the examination,
p.(None): but he may not participate in the deliberations or decisions of the Ethics Committee.
p.(None): 3.2.6. The Ethics Committee may seek the assistance of experts in specific areas other than its members.
p.(None): 3.3. Procedures
p.(None): The Ethics Committee should define, document and follow its procedures in writing, which should include:
p.(None): 3.3.1. Determining the composition of the Ethics Committee (names and qualifications of members) and the legislative form by which
p.(None): Ethics committee established.
p.(None): 3.3.2. Plan meetings, lead them, and notify members.
p.(None): 3.3.3. Conducting initial and continuous review of tests.
p.(None): 3.3.4. Determining the frequency of audits as needed.
p.(None): 3.3.5. In accordance with the applicable legal regulations, the definition of carrying out expedited review and
p.(None): granting approval / positive opinion on minor changes to ongoing testing already received previously
p.(None): approval / positive opinion from the Ethics Committee.
p.(None): 3.3.6. Note that no interviewee may be included in the examination before it is taken
p.(None): approved by the Ethics Committee.
p.(None): 3.3.7. Note that no deviation from the Test Protocol or its amendment without
p.(None): the prior written approval / positive opinion of the Ethics Committee, except when promptly removed
p.(None): imminent danger to the respondent, that is, when the amendments relate exclusively to logistical or
p.(None): administrative aspects of testing (eg change of monitor telephone number) (see 4.5.2).
p.(None): 3.3.8. Note that the researcher is obliged to immediately inform the Ethics Committee of:
p.(None): a) deviations or amendments to the Test Protocol in order to remove the immediate one
p.(None): hazards per respondent (see 3.3.7., 4.5.2., 4.5.4.);
p.(None): b) amendments that increase the risk to the respondent and / or significantly affect the implementation
p.(None): tests (see 4.10.2.);
p.(None): c) any serious and unexpected adverse reactions;
p.(None): d) new knowledge that may adversely affect the safety of the interviewee or the conduct of the examination.
p.(None): 3.3.9. Ensures that the Ethics Committee promptly, in writing, notifies the researcher / institution of:
p.(None): a) their decisions / opinions regarding the examination;
...
Social / education
Searching for indicator education:
(return to top)
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
p.(None): experience to perform their tasks.
p.(None): 2.9. Prior to enrolling in a clinical trial, each subject should voluntarily consent to participate in a clinical trial
p.(None): examination.
p.(None): 2.10. All clinical trial information should be documented and documented and stored on file
p.(None): a way that enables accurate reporting, interpretation and verification.
p.(None): 2.11. Information that can reveal the identity of respondents should be protected in accordance with the principles of privacy and
p.(None): confidentiality in accordance with applicable law.
p.(None): 2.12. The production, handling and storage / storage of tested products must be in accordance with the applicable regulations
p.(None): Good manufacturing practice. They should be used in accordance with the approved Protocol.
p.(None): 2.13. Procedures should be established to ensure the quality of all aspects of the clinical trial.
p.(None): 3. ETHICAL COMMITTEE
p.(None): 3.1. Responsibilities
p.(None): 3.1.1. The Ethics Committee protects the rights, safety and well-being of all respondents, especially sensitive patients.
p.(None): 3.1.2. The ethics committee should have the following documents: Clinical trial protocol and amendments thereto
p.(None): and Appendices, Forms for Informed Consent of the Respondents, and their Amendments that the Researcher intends to use
p.(None): in the examination, the procedure for engaging respondents (e.g., advertisements), written information intended
p.(None): respondents, Researcher Brochure, security information available, payment information and reimbursements
...
p.(None): a) deviations or amendments to the Test Protocol in order to remove the immediate one
p.(None): hazards per respondent (see 3.3.7., 4.5.2., 4.5.4.);
p.(None): b) amendments that increase the risk to the respondent and / or significantly affect the implementation
p.(None): tests (see 4.10.2.);
p.(None): c) any serious and unexpected adverse reactions;
p.(None): d) new knowledge that may adversely affect the safety of the interviewee or the conduct of the examination.
p.(None): 3.3.9. Ensures that the Ethics Committee promptly, in writing, notifies the researcher / institution of:
p.(None): a) their decisions / opinions regarding the examination;
p.(None): b) the reasons for such a decision / opinion;
p.(None): c) the procedures for appealing the decision / opinion.
p.(None): 3.4. Documentation
p.(None): The Ethics Committee should keep all relevant documentation (eg written procedures, a list of members with their members)
p.(None): occupations, documents received, meeting minutes and correspondence) from
p.(None): at least three years after completion of the tests and to make them available at the request of the competent authorities.
p.(None): Researchers, sponsors or authorities may request the Ethics Committee to submit their procedures and list
p.(None): members.
p.(None): 4. RESEARCHER
p.(None): 4.1. Researcher qualifications
p.(None): 4.1.1. In order to take on the duties of conducting the examination properly, the researcher should be qualified
p.(None): in terms of education, training and experience, the qualifications should meet current legal requirements
p.(None): regulations and should provide evidence of their qualifications through an updated CV and / or other relevant
p.(None): the documentation requested by the sponsor, the Ethics Committee and / or the competent authorities.
p.(None): 4.1.2. The researcher must be familiar with the proper application of the product under test as described in
p.(None): Protocol, Brochure
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 55
p.(None): for the researcher, product information, and other sources of information provided by the sponsor.
p.(None): 4.1.3. The researcher must be familiar with and adhere to Good Clinical Practice and applicable law.
p.(None): 4.1.4. The researcher / institution should allow the sponsor to monitor and leave, as well as inspection by the competent
p.(None): bodies.
p.(None): 4.1.5. The researcher should draw up a list of appropriately qualified persons to whom he or she has been assigned
p.(None): significant testing obligations.
p.(None): 4.2. Appropriate options
p.(None): 4.2.1. The researcher should document (eg retrospective data) the potential for recruitment
p.(None): the required number of appropriate respondents in the agreed period.
p.(None): 4.2.2. The researcher should have sufficient time to properly conduct and complete the examination within the agreed time
p.(None): deadline.
p.(None): 4.2.3. For the test to be conducted properly and safely, the researcher should have a sufficient number
p.(None): qualified personnel and appropriate facilities and equipment requirements.
p.(None): 4.2.4. The researcher must ensure that the personnel involved in the examination are properly informed of
p.(None): The protocol, the product being tested and its obligations and functions related to the testing.
...
Social / embryo
Searching for indicator embryo:
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p.(None): an impartial witness present. After the respondent or his legal representative is read
p.(None): a written consent form and other written notice intended for the respondents, and after the respondent
p.(None): or his legal representative orally consent to the respondent's participation in the examination, the respondent personally
p.(None): sign and date a written consent form, if capable, and also an impartial witness.
p.(None): By signing the written consent form, the witness confirms that the information on the form and other information is correct
p.(None): explained to the respondent or his legal representative that they were clear and that according to his
p.(None): assessment, the respondent or his legal representative understood and voluntarily gave his or her consent.
p.(None): 4.8.10. Consent interview, consent form and other written notices intended
p.(None): respondents should include the following explanations:
p.(None): a) the clinical trial is of a research nature;
p.(None): b) the objective of the examination;
p.(None): c) the therapy being tested and the possibility of accidental inclusion in one of the treatment groups;
p.(None): d) the procedures provided for in the test, including invasive procedures;
p.(None): e) Respondents' duties;
p.(None): f) experimental aspects of testing;
p.(None): g) the foreseeable risks and inconveniences for the respondent, ie embryo, fetus or infant;
p.(None): h) benefits that can be expected. When no clinical benefit is expected for the respondent,
p.(None): he must be warned;
p.(None): i) alternative therapeutic procedures and / or treatment options available to the respondent at
p.(None): the availability and their potential risks and benefits;
p.(None): j) compensation and / or treatment provided to the respondent in case of injury caused by the examination;
p.(None): k) the estimated schedule of payment of installments of any compensation to the respondents for participation in the examination;
p.(None): l) any other costs foreseen for the respondent to participate in the examination;
p.(None): m) that the respondent's participation in the examination is voluntary and that the respondent may leave at any time
p.(None): that is, to interrupt the examination without suffering any consequences of its decision;
p.(None): n) that the monitor, the auditor, the Ethics Committee and the competent authorities will have direct access to the original healthcare
p.(None): the data of the subjects for the purpose of verifying the procedures, ie obtained data in the clinical trial, with full protection
p.(None): secrecy of the respondent's identity within the limits of the applicable laws and regulations, as well as that of the respondent or his
p.(None): the legal representative permits such access to the data by signing informed consent;
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): clinical trial decision making (eg associates, specialists, research associates).
p.(None): 1.57. Respondent
p.(None): The person participating in the clinical trial, whether receiving the test product or
p.(None): participates to control drug administration.
p.(None): 1.58. Respondent's identification code
p.(None): The unique identification code assigned by the researcher to each respondent to protect the respondent's identity,
p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): 1.34. Explorer
p.(None): The person responsible for conducting the clinical trial at the place where it is conducted. If testing on someone
p.(None): The site is run by a research team, the researcher responsible for conducting the clinical trial is
p.(None): principal investigator.
p.(None): 1.35. Researcher / Institution
p.(None): The term "researcher and / or institution" is used if required by applicable regulations.
p.(None): 1.36. Brochure for the researcher
p.(None): A set of clinical and preclinical data on a test product relevant to its testing in humans
p.(None): (see
p.(None): 7. Researcher Brochure).
p.(None): 1.37. Legal representative
p.(None): An individual or a legal or other body empowered by applicable law to give consent on behalf of respondents
p.(None): participation in a clinical trial.
p.(None): 1.38. Monitoring
p.(None): The process of monitoring the clinical trial process and confirming that implementation, documentation, and
p.(None): reporting in accordance with the Clinical Trial Protocol, standard operating procedures, Good
p.(None): clinical practice and applicable law.
p.(None): 1.39. Monitoring report
p.(None): A written report that the monitor submits to the sponsor after each visit to the examination center, as well as a report on
p.(None): any new knowledge regarding testing in accordance with the sponsor's standard operating procedures.
p.(None): 1.40. Multicenter clinical trial
p.(None): A clinical trial conducted in accordance with the unique clinical trial protocol in
p.(None): multiple centers and is conducted by multiple researchers, whether the test centers are in the same or
p.(None): different countries.
p.(None): 1.41. Preclinical research
p.(None): Non-human biomedical research.
p.(None): 1.42. Opinion of the Independent Ethics Committee
p.(None): Advice and / or recommendation of the Independent Ethics Committee.
p.(None): 1.43. Original health information
p.(None): See Original data.
p.(None): 1.44. Clinical trial protocol
p.(None): Document describing the objectives, plan, test methodology, method of statistical data processing and
p.(None): organization of testing. The protocol usually contains either an introduction and a rational basis for testing or this may
p.(None): be described by a protocol amendment.
p.(None): 1.45. Changes and additions to the Clinical Trial Protocol
p.(None): Description of the modification of the Clinical Trial Protocol in writing, or its official explanation.
p.(None): 1.46. Quality assurance
p.(None): All planned and systematic activities aimed at ensuring consistency of implementation
p.(None): clinical trial, documenting results and reporting with Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 1.47. Quality control
p.(None): Operational techniques and quality assurance activities aimed at verifying that they are
p.(None): all the quality requirements related to the test are met.
p.(None): 1.48. Randomization
p.(None): The process of randomly selecting (classifying) subjects into a therapeutic or control group, thereby reducing it
p.(None): researcher bias.
p.(None): 1.49. Competent authorities
p.(None): Bodies competent for the adoption of legislation. For the purposes of these guidelines, the term competent authorities includes bodies which
p.(None): have the regulatory power to legislate including review a submitted clinical
p.(None): documentation and inspection (see 1.29).
p.(None): 1.50. Serious adverse event or serious adverse reaction
...
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
p.(None): 2.8. All persons participating in the examination must have the appropriate education, expertise and skills
p.(None): experience to perform their tasks.
p.(None): 2.9. Prior to enrolling in a clinical trial, each subject should voluntarily consent to participate in a clinical trial
p.(None): examination.
p.(None): 2.10. All clinical trial information should be documented and documented and stored on file
p.(None): a way that enables accurate reporting, interpretation and verification.
p.(None): 2.11. Information that can reveal the identity of respondents should be protected in accordance with the principles of privacy and
p.(None): confidentiality in accordance with applicable law.
p.(None): 2.12. The production, handling and storage / storage of tested products must be in accordance with the applicable regulations
p.(None): Good manufacturing practice. They should be used in accordance with the approved Protocol.
p.(None): 2.13. Procedures should be established to ensure the quality of all aspects of the clinical trial.
p.(None): 3. ETHICAL COMMITTEE
p.(None): 3.1. Responsibilities
p.(None): 3.1.1. The Ethics Committee protects the rights, safety and well-being of all respondents, especially sensitive patients.
p.(None): 3.1.2. The ethics committee should have the following documents: Clinical trial protocol and amendments thereto
p.(None): and Appendices, Forms for Informed Consent of the Respondents, and their Amendments that the Researcher intends to use
p.(None): in the examination, the procedure for engaging respondents (e.g., advertisements), written information intended
p.(None): respondents, Researcher Brochure, security information available, payment information and reimbursements
p.(None): for respondents, the researcher's current biography and / or other documents attesting to his or her own
p.(None): qualifications and other documentation at the request of the Ethics Committee. The Ethics Committee should consider and evaluate
p.(None): reviewed clinical trial within a reasonable timeframe and to provide its opinion in writing clearly
p.(None): identifying the clinical trial as well as the documents and dates considered for the following:
p.(None): - approval / positive opinion;
p.(None): - necessary modifications to the test prior to approval / positive opinion;
p.(None): - rejection / negative opinion;
p.(None): - Permanent or temporary revocation of any earlier opinion.
p.(None): 3.1.3. The Ethics Committee should consider the qualifications of the researcher for the proposed examination at
p.(None): on the basis of the biography or other relevant documentation requested by the Ethics Committee.
p.(None): 3.1.4. The Ethics Committee should conduct continuous monitoring of each ongoing examination, in periods
p.(None): which are appropriate for the risk assessment of the respondents and at least once a year.
p.(None): 3.1.5. The Ethics Committee has the right to request that the respondent be provided with more information than the one indicated in
p.(None): of items 4.8.10. when, in the opinion of the Ethics Committee, such supplementary information
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p.(None): Monday, March 12, 2012
p.(None): can significantly contribute to the protection of the rights, safety and / or well-being of respondents.
p.(None): 3.1.6. When should a non-therapeutic clinical trial be conducted for which legal consent is required
p.(None): (see 4.8.12, 4.8.14), the Ethics Committee should determine whether they are in the proposed Testing Protocol
p.(None): and / or other documentation sufficiently considered ethical issues and whether they meet current legal requirements
p.(None): regulations for such tests.
p.(None): 3.1.7. When the Examination Protocol indicates that it is not possible to obtain the consent of the subjects in a timely manner or
p.(None): of his legal representative (ie in an emergency, see 4.8.15), the Ethics Committee should determine whether
p.(None): the proposed Testing Protocol and / or other documentation sufficiently considered ethical issues and whether
p.(None): meet the applicable legal requirements for such tests.
p.(None): 3.1.8. The Ethics Committee considers the amount and method of payment of reimbursement to respondents to remove
p.(None): the potential for forcible or inappropriate influence on the respondents. Payment of compensation is required
p.(None): distribute in installments, not the full amount upon completion of respondent's participation in
p.(None): examination.
p.(None): 3.1.9. The Ethics Committee should provide payment information to the respondents, including manner, amount and schedule
p.(None): payments, to be defined in the respondent's written consent form, as well as in any other written notice
p.(None): for the respondents. The method of payment in proportionate installments should be indicated.
p.(None): 3.2. Composition, functions and procedures
p.(None): 3.2.1. The ethics committee should be composed of persons who have the appropriate qualifications and experience required for
p.(None): consideration and evaluation of the scientific, medical and ethical aspects of the proposed test. It is recommended that Ethical
p.(None): committee:
p.(None): a) has at least five members;
p.(None): b) at least one member whose sphere of interest is unscientific;
p.(None): c) at least one member independent of the institution or the place where the examination is conducted.
p.(None): To prevent conflicts of interest, only those Ethics Committee members who are not researchers and are independent of
p.(None): sponsors can vote, or give their opinion on clinical trial issues. Member list
p.(None): The Ethics Committee and their qualifications should be separately kept and regularly updated.
p.(None): 3.2.2. The Ethics Committee should perform its function in accordance with written standard operating procedures,
p.(None): document their work and make minutes of their meetings, and the Good Clinical should be adhered to
p.(None): practices and applicable laws.
p.(None): 3.2.3. The Ethics Committee should make its decisions at the pre-announced meetings, at least attended
p.(None): a quorum, in accordance with written operating procedures.
p.(None): 3.2.4. Only members of the Ethics Committee shall have the right to vote or to express opinions and / or recommendations
p.(None): committees involved in the deliberation and discussion.
p.(None): 3.2.5. Researchers may be required to provide the Ethics Committee with information on any aspect of the examination,
p.(None): but he may not participate in the deliberations or decisions of the Ethics Committee.
p.(None): 3.2.6. The Ethics Committee may seek the assistance of experts in specific areas other than its members.
p.(None): 3.3. Procedures
p.(None): The Ethics Committee should define, document and follow its procedures in writing, which should include:
p.(None): 3.3.1. Determining the composition of the Ethics Committee (names and qualifications of members) and the legislative form by which
p.(None): Ethics committee established.
p.(None): 3.3.2. Plan meetings, lead them, and notify members.
p.(None): 3.3.3. Conducting initial and continuous review of tests.
p.(None): 3.3.4. Determining the frequency of audits as needed.
p.(None): 3.3.5. In accordance with the applicable legal regulations, the definition of carrying out expedited review and
p.(None): granting approval / positive opinion on minor changes to ongoing testing already received previously
p.(None): approval / positive opinion from the Ethics Committee.
p.(None): 3.3.6. Note that no interviewee may be included in the examination before it is taken
p.(None): approved by the Ethics Committee.
p.(None): 3.3.7. Note that no deviation from the Test Protocol or its amendment without
p.(None): the prior written approval / positive opinion of the Ethics Committee, except when promptly removed
p.(None): imminent danger to the respondent, that is, when the amendments relate exclusively to logistical or
p.(None): administrative aspects of testing (eg change of monitor telephone number) (see 4.5.2).
p.(None): 3.3.8. Note that the researcher is obliged to immediately inform the Ethics Committee of:
p.(None): a) deviations or amendments to the Test Protocol in order to remove the immediate one
p.(None): hazards per respondent (see 3.3.7., 4.5.2., 4.5.4.);
p.(None): b) amendments that increase the risk to the respondent and / or significantly affect the implementation
p.(None): tests (see 4.10.2.);
p.(None): c) any serious and unexpected adverse reactions;
p.(None): d) new knowledge that may adversely affect the safety of the interviewee or the conduct of the examination.
p.(None): 3.3.9. Ensures that the Ethics Committee promptly, in writing, notifies the researcher / institution of:
p.(None): a) their decisions / opinions regarding the examination;
p.(None): b) the reasons for such a decision / opinion;
p.(None): c) the procedures for appealing the decision / opinion.
p.(None): 3.4. Documentation
p.(None): The Ethics Committee should keep all relevant documentation (eg written procedures, a list of members with their members)
p.(None): occupations, documents received, meeting minutes and correspondence) from
p.(None): at least three years after completion of the tests and to make them available at the request of the competent authorities.
p.(None): Researchers, sponsors or authorities may request the Ethics Committee to submit their procedures and list
p.(None): members.
p.(None): 4. RESEARCHER
p.(None): 4.1. Researcher qualifications
p.(None): 4.1.1. In order to take on the duties of conducting the examination properly, the researcher should be qualified
p.(None): in terms of education, training and experience, the qualifications should meet current legal requirements
p.(None): regulations and should provide evidence of their qualifications through an updated CV and / or other relevant
p.(None): the documentation requested by the sponsor, the Ethics Committee and / or the competent authorities.
p.(None): 4.1.2. The researcher must be familiar with the proper application of the product under test as described in
p.(None): Protocol, Brochure
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p.(None): for the researcher, product information, and other sources of information provided by the sponsor.
p.(None): 4.1.3. The researcher must be familiar with and adhere to Good Clinical Practice and applicable law.
p.(None): 4.1.4. The researcher / institution should allow the sponsor to monitor and leave, as well as inspection by the competent
p.(None): bodies.
...
p.(None): 4.2.4. The researcher must ensure that the personnel involved in the examination are properly informed of
p.(None): The protocol, the product being tested and its obligations and functions related to the testing.
p.(None): 4.3. Medical care of respondents
p.(None): 4.3.1. Qualified Doctor of Medicine, or if necessary Doctor of Dentistry, who
p.(None): the researcher or investigator in the clinical trial should be responsible for bringing all medical
p.(None): testing decisions.
p.(None): 4.3.2. During and after the participation of the respondents in the examination, the researcher / institution should ensure that it is appropriate
p.(None): medical care to respondents in the event of any adverse event related to the trial,
p.(None): including clinically relevant laboratory findings. Does the researcher / institution find that
p.(None): the respondent, meanwhile, was ill with some illness, should be informed of the need for his treatment.
p.(None): 4.3.3. It is recommended that the researcher inform the respondent's family doctor of his
p.(None): participation in the examination, if the respondent has it and agrees.
p.(None): 4.3.4. Although the respondent is not required to explain the reasons for his or her early withdrawal from the examination, the investigator does
p.(None): reasonable efforts should be made to determine the reasons, with full respect for the rights of the respondents.
p.(None): 4.4. Communication with the Ethics Committee
p.(None): 4.4.1. Prior to the start of the test, the researcher / institution should have written and dated approval / positive
p.(None): opinion of the Ethics Committee on the Testing Protocol, the written consent form and its amendments, the procedure for
p.(None): the recruitment of respondents (eg through advertisements) and any other written information intended for the respondents.
p.(None): 4.4.2. An integral part of the written request submitted by the researcher / institution to Ethics
p.(None): the board is also the current version of the Researcher Brochure. If there is an amendment to the Brochure for
p.(None): researchers during the examination, the researcher / institution is obliged to submit to the Ethics Committee
p.(None): updated Brochures.
p.(None): 4.4.3. During the examination, the researcher / institution shall submit to the Ethics Committee all documents that are
p.(None): subject to change.
p.(None): 4.5. Protocol Compliance
p.(None): 4.5.1. The investigator / institution should carry out the test in accordance with the Test Protocol
p.(None): approved by sponsors, competent authorities and the Ethics Committee. For confirmation
p.(None): Under the agreement, the researcher / institution and sponsor sign a Protocol or other agreement.
p.(None): 4.5.2. The researcher does not need to deviate from the Protocol, that is, to amend it without agreeing with the sponsor,
p.(None): as well as without the prior written approval / positive opinion of the Ethics Committee, except when necessary to prevent
p.(None): imminent danger to the respondents, or when the changes relate exclusively to logistical or
p.(None): administrative aspects of testing (eg changing the phone number of the monitor).
p.(None): 4.5.3. The researcher or the person designated by the researcher should document and explain any deviation from
p.(None): of the approved Protocol.
p.(None): 4.5.4. The researcher may deviate from the Protocol or change it without prior approval / positive
p.(None): opinions of the Ethics Committee solely to eliminate imminent danger to respondents. Deviations from
p.(None): The Protocol, that is, its amendments, the reasons for their introduction and the proposed amendments
p.(None): The protocol should be delivered as soon as possible:
p.(None): a) Ethics Committee for evaluation and approval / positive opinion,
p.(None): b) the sponsor for consent,
p.(None): c) the competent authorities.
p.(None): 4.6. Tested product
p.(None): 4.6.1. The researcher / institution is responsible for recording the inputs and outputs of the test product at the center
p.(None): testing.
p.(None): 4.6.2. When permitted, or necessary, the researcher / institution needs all or part of it
p.(None): the obligation to record the inputs and outputs of the test product at the test center is transferred to
p.(None): pharmacist or other appropriate person under the supervision of the researcher / institution.
p.(None): 4.6.3. Researcher / institution and / or pharmacist or other appropriate person appointed by
p.(None): the researcher / institution should properly record the delivery of the product and its condition at the test center, list
p.(None): use for each respondent, and returning it to the sponsor or otherwise removing the unused product.
p.(None): Records should include dates, quantities, serial numbers, shelf life (where appropriate) and
p.(None): a unique identification code linking the product being tested and the respondent. The researcher needs to be neat
p.(None): record whether the subjects received the doses indicated in the Test Protocol and agree on all the quantities tested
p.(None): product obtained from the sponsor.
p.(None): 4.6.4. The test product should be stored in accordance with the sponsor's instructions (see 5.13.2. I
p.(None): 5.14.3.) And applicable legal regulations.
p.(None): 4.6.5. The researcher should ensure that the test product is used only in accordance with the approved one
p.(None): Test protocol.
p.(None): 4.6.6. The researcher / person appointed by the researcher / institution should explain the correct one
p.(None): the application of the test product to each respondent and that from time to time, in periods appropriate to the individual
p.(None): clinical trial, checks that each subject adheres to the instructions given.
p.(None): 4.7. Randomization and decryption procedures
p.(None): The researcher should adhere to the random selection procedures (if provided for testing) and should
p.(None): ensure that decryption takes place solely in accordance with the Protocol. If the test is blind,
p.(None): the researcher should promptly provide the sponsor with documentation and reasons for any early disclosure of the code that
p.(None): connects the respondent and the product under investigation (eg accidentally or due to a serious adverse event).
p.(None): 4.8. Consent of respondents
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p.(None): Monday, March 12, 2012
p.(None): 4.8.1. In the process of obtaining and recording the consent of the respondents, the researcher should adhere to the valid ones
p.(None): legislation, good clinical practice and ethical principles stemming from the Declaration of Helsinki. Before you begin
p.(None): examinations, the researcher should have the written approval / positive opinion of the Ethics Committee on the written form
p.(None): consent to other written notices intended for the respondents.
p.(None): 4.8.2. The written consent form of the respondents and all other written information intended for the respondents should be provided
p.(None): amendments after each new information that might affect the consent of the respondents. Before application,
p.(None): Amended respondent consent form and other written notice intended
p.(None): respondents should be approved / approved by the Ethics Committee. Respondent respectively his / her legal
p.(None): the deputy should be informed in good time of any new information that may influence the decision
p.(None): respondents to continue participation in the examination. Information on this shall be kept in writing.
p.(None): 4.8.3. Neither the researcher nor the staff participating in the test shall coerce or inappropriately influence
p.(None): respondents to participate in, or continue to participate in, the examination.
p.(None): 4.8.4. None of the oral and written examination-related information, including consent form
p.(None): respondents should not be written in a language that would deprive the respondent or his legal representative
p.(None): any legal right, or by which the researcher, institution, sponsor or his representative would be exonerated
p.(None): liability for negligence.
p.(None): 4.8.5. The researcher or the person designated by the researcher should inform the respondent, that is, his / her legal
p.(None): if the respondent is not competent to give consent, on all aspects of the examination, including written notices
p.(None): for which approval / positive opinion of the Ethics Committee has been obtained.
p.(None): 4.8.6. Language used in oral and written examination notices, including
p.(None): the respondent's consent form should not contain expert terminology but should be understandable to the respondent
p.(None): that is, his legal representative and impartial witness.
p.(None): 4.8.7. Before obtaining consent, the researcher or the person appointed by the researcher should provide
p.(None): respondent or his / her legal representative sufficient time and opportunity to find out details about
p.(None): examination to decide whether or not to participate in it. All questions related to the examination should
p.(None): to answer until the respondent or his legal representative is satisfied with them.
p.(None): 4.8.8. The written consent form must be signed and dated before the interviewee is included in the examination
p.(None): by the respondent or his legal representative, also signed by the person who
p.(None): interviewed the respondent / legal representative.
p.(None): 4.8.9. If the respondent or his legal representative cannot read, there must be throughout the interview
p.(None): an impartial witness present. After the respondent or his legal representative is read
p.(None): a written consent form and other written notice intended for the respondents, and after the respondent
p.(None): or his legal representative orally consent to the respondent's participation in the examination, the respondent personally
...
p.(None): receive signed and dated copies of the updated consent form as well as copies of changes and
p.(None): supplement to information intended for respondents.
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p.(None): 4.8.12. When a clinical trial (whether therapeutic action is expected or not) involves subjects for
p.(None): whose participation requires the consent of a legal representative (eg minors or patients with severe
p.(None): dementia), such respondents should be introduced to the examination in accordance with their ability to understand and from those
p.(None): who are able to obtain a signed and dated written consent form.
p.(None): 4.8.13. In addition to the one described under 4.8.14, non-therapeutic testing (ie a non-
p.(None): expects a direct clinical benefit for the respondent) should be conducted on subjects who give their personal consent and
p.(None): who sign and date the consent form.
p.(None): 4.8.14. Non-therapeutic testing may also be conducted on subjects with assured consent
p.(None): their legal representatives, if the following conditions are met:
p.(None): a) the examination cannot be conducted on subjects who can give their personal consent;
p.(None): b) the foreseeable risks for the respondents are small;
p.(None): c) the negative impact on the well-being of the respondents is minimal and low;
p.(None): d) the examination is not prohibited by law;
p.(None): e) The approval / positive opinion of the Ethics Committee on inclusion has been explicitly sought and obtained
p.(None): of these respondents.
p.(None): With justifiable exceptions, these tests should be performed in patients whose disease or
p.(None): condition is the test product intended. Respondents should be closely monitored and excluded from testing,
p.(None): unless there is doubt about the discomfort caused by the examination.
p.(None): 4.8.15. In urgent cases where it is not possible to obtain the prior consent of the respondents, it should
p.(None): ask the respondent's legal representative. When it is not possible to obtain the prior consent of the respondents, a
p.(None): his legal representative is not available, the inclusion of respondents requires the measures described in the Protocol, in addition
p.(None): the approval of the Ethics Committee, in order to protect the rights, safety and welfare of the respondents and with respect
p.(None): applicable legislation. The respondent or his legal representative needs as soon as possible
p.(None): to notify the examination and request their consent to continue the examination or others
p.(None): appropriate consent (see 4.8.10.)
p.(None): 4.9 Record keeping and reporting
p.(None): 4.9.1. The researcher should ensure that the data reported is accurate, complete, legible and up-to-date
p.(None): to the sponsor in the test lists and other required reports.
...
p.(None): the period specified by the sponsor in the Protocol.
p.(None): 4.11.3. When reporting a death, the investigator should provide everything to the sponsor and the Ethics Committee
p.(None): additional information requested (eg autopsy findings and final medical report).
p.(None): 4.12. Premature completion or delay of clinical trial
p.(None): If for any reason the test is terminated or postponed early, the investigator / institution shall do so
p.(None): inform the respondents immediately, ensure their proper treatment and follow-up, and inform the competent
p.(None): bodies in accordance with applicable legal regulations. Besides:
p.(None): 4.12.1. If the researcher interrupts or postpones the examination without the prior consent of the sponsor, he shall be obliged to do so
p.(None): inform the institution and the investigator / institution should immediately inform the sponsor and the Ethics Committee and
p.(None): provide them with a detailed written explanation of the interruption or adjournment.
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p.(None): Monday, March 12, 2012
p.(None): 4.12.2. If the sponsor interrupts or postpones the examination (see 5.21), the investigator should be informed immediately
p.(None): institution and the researcher / institution should immediately inform the Ethics Committee and provide them in writing
p.(None): explanation of interruption or delay.
p.(None): 4.12.3. If the Ethics Committee withdraws its approval / positive opinion on the examination
p.(None): (see 3.1.2 and 3.3.9), the researcher is obliged to inform the institution and the researcher / institution should
p.(None): immediately notify the sponsor and provide them with a detailed written explanation of the interruption or delay.
p.(None): 4.13. Final report from the researcher
p.(None): Upon completion of the examination, the investigator should inform the institution that the examination has been completed;
p.(None): the researcher / institution should submit to the Ethics Committee a summary of the test results and all to the competent authorities
p.(None): required reports.
p.(None): 5. SPONSOR
p.(None): 5.1. Quality assurance and control
p.(None): 5.1.1. The sponsor is responsible for the implementation and quality assurance and quality control systems through
p.(None): standard operating procedures, to ensure that conducting a clinical trial, obtaining
p.(None): data, documentation and reporting are in accordance with the Protocol, Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 5.1.2. The sponsor is responsible for contracting with all parties involved to ensure direct access
p.(None): (see 1.21.) all test centers, original data / documents and
p.(None): reports, for the purpose of monitoring and referral by the sponsor and domestic or foreign inspection.
p.(None): 5.1.3. Quality control should be carried out at all levels of data handling in order to ensure their quality
p.(None): reliability and proper processing.
p.(None): 5.1.4. Contracts concluded between sponsors and researchers / institution and other parties
p.(None): those involved in the clinical trial should be in writing as an integral part of the Protocol or as
p.(None): special contract.
p.(None): 5.2. Contracting research organization
p.(None): 5.2.1. The sponsor may delegate all of its obligations or functions or part thereof to a contract research agent
p.(None): organization, but the ultimate responsibility for the quality and integrity of the test results is always borne by the sponsor. Contractual
p.(None): the research organization should meet the requirements of quality assurance and control.
p.(None): 5.2.2. Any obligation and function in connection with the examination, which is delegated and accepted by the contracting authority
p.(None): research organizations, should be stated in writing.
p.(None): 5.2.3. Any examination obligation and function not specifically delegated and accepted by
p.(None): contract research organization, retains sponsor.
p.(None): 5.2.4. Anything in these guidelines that applies to the sponsor applies to the contracting research organization in that sponsor
p.(None): the extent to which the contracting research organization has assumed obligations and functions from the sponsor in relation to
p.(None): by conducting a clinical trial.
p.(None): 5.3. Professional doctoral opinion
p.(None): Medical professionals with appropriate qualifications should be identified, which will always be easy
p.(None): available, to clarify medical issues and resolve test issues. If necessary,
p.(None): the sponsor may also appoint external consultants for this purpose.
p.(None): 5.4. Test plan
p.(None): 5.4.1. The sponsor should, as appropriate, hire qualified persons (eg biostatistical, clinical)
p.(None): pharmacologists and doctors) at all stages of testing, from the development of the Protocol and the test
p.(None): list, through analysis planning, to analyzing and preparing interim and final clinical reports
p.(None): testing.
p.(None): 5.4.2. Explanations regarding the Protocol and amendments to the Protocol are provided in Chapter 6, "ICH"
p.(None): Guidelines for the structure and content of clinical trial reports and other "ICH" guidelines
p.(None): related to test planning, protocol development and testing.
p.(None): 5.5. Test management, data handling and record keeping
p.(None): 5.5.1. The sponsor should appoint appropriately qualified staff to oversee the whole
p.(None): conducting tests, for handling data, for validating data, for conducting statistical analysis
p.(None): and preparing test reports.
p.(None): 5.5.2. The sponsor may set up independent monitoring committees to periodically evaluate progress
p.(None): clinical trial, including safety data and critical conclusions on drug efficacy, and for recommendation
p.(None): to the sponsor whether to continue, modify, or terminate the examination. An independent commission should have written documents
p.(None): standard operating procedures and to keep written records of all its meetings.
p.(None): 5.5.3. When the test uses electronic data management, that is, a remote electronic system, the sponsor
p.(None): should:
...
p.(None): examinations, ie to provide redress, except in the case of a malpractice lawsuit and / or negligence.
p.(None): 5.8.2. The sponsor, in its provisions and procedures, should determine the amount of treatment costs of the subjects in
p.(None): in the case of injuries arising from his participation in the examination in accordance with the applicable legal provisions.
p.(None): 5.8.3. The procedure and manner of providing compensation to the respondent should be in accordance with the applicable legal regulations.
p.(None): 5.9. Financing
p.(None): The financial aspects of the test should be documented by a contract between the sponsor and the researcher / institution.
p.(None): 5.10. Notification / submission of requests to competent authorities
p.(None): Prior to the commencement of the clinical trial, the sponsor (or sponsor and investigator, if applicable)
p.(None): regulations) should submit to the appropriate authorities the necessary requirements to begin testing on
p.(None): assessment, acceptance and / or approval (in accordance with applicable legal regulations). Every application / request should
p.(None): be dated and contain sufficient information to identify the Protocol.
p.(None): 5.11. Ethics Committee Decision
p.(None): 5.11.1. The sponsor from the researcher / institution should receive:
p.(None): a) the name and address of the Ethics Committee of the institution;
p.(None): b) a statement by the Ethics Committee that its composition and operation are in accordance with Good Clinical Practice and applicable laws; and
p.(None): regulations;
p.(None): c) a documented approval / positive opinion of the Ethics Committee and, if requested by the sponsor, a copy
p.(None): current Protocol, respondent's written consent form, and any other written notice
p.(None): intended for the respondents, their recruitment process, as well as documentation relating to compensation
p.(None): respondents and other documents requested by the Ethics Committee.
p.(None): 5.11.2. If the Ethics Committee requires its approval / positive opinion to modify any aspect of the examination
p.(None): such as amendments to the Protocol, respondent's written consent form, other written notices and / or
p.(None): other procedures intended for respondents, the sponsor must receive a copy from the researcher / institution
p.(None): amendments documents and date of approval / positive opinion of the Ethics Committee.
p.(None): 5.11.3. The sponsor should receive documentation and re-approval dates from the researcher / institution, respectively
p.(None): reassessments with a positive decision of the Ethics Committee as well as withdrawal or delay of approval / positive
p.(None): opinions.
p.(None): 5.12. Tested product data
p.(None): 5.12.1. When planning the test, the sponsor should provide sufficient safety information and
p.(None): drug efficacy from preclinical and / or clinical trials that justify human exposure
p.(None): the route of administration, the dosage, the length of the test and the appropriate population planned for the test.
p.(None): 5.12.2. When significant new information is available, the sponsor should update the Researcher Brochure (see
p.(None): 7.)
p.(None): 5.13. Production, packaging and labeling and coding of the product under test
p.(None): 5.13.1. The sponsor should ensure that the product under study (including, if necessary, a comparative drug)
p.(None): and placebo) characterized according to the stage of its development, to have been produced in accordance with the Good
p.(None): manufacturer's practice, and that it is encrypted and marked in a way that protects the blind process, if any. Besides,
p.(None): labeling should be in accordance with applicable legal regulations.
p.(None): 5.13.2. The sponsor should indicate appropriate storage conditions for the drug such as temperature, protection against influences
p.(None): light, storage time, drug reconstitution procedures and infusion agents as appropriate
p.(None): planned. The sponsor should inform all parties involved (i.e. monitors, researchers,
p.(None): pharmacists, warehouse managers).
p.(None): 5.13.3. The packaging of the test product should be such as to prevent its contamination and
p.(None): unacceptable degree of damage during transport and storage.
p.(None): 5.13.4. In blind tests, the encryption system of the product under test should also contain
p.(None): a mechanism that allows rapid identification of the drug in an emergency but which prevents it from becoming blind
p.(None): interrupts unnoticed.
p.(None): No. 19 - Page 60 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 5.13.5. If significant changes are made to the formulation of the test or comparative product during
p.(None): clinical development, results of any additional formulated drug study (e.g., stability, degree of availability,
p.(None): bioavailability) should be available before using the new formulation in a clinical trial to evaluate that
p.(None): whether such changes would significantly alter the pharmacokinetic profile of the product.
p.(None): 5.14. Delivering and handling the tested product
p.(None): 5.14.1. The sponsor is responsible for delivering the test product to the researcher / institution.
p.(None): 5.14.2. The sponsor does not need to provide the investigator / institution with the product under test until he has all the necessary information
p.(None): documentation (eg approval / positive opinion of the Ethics Committee and competent authorities).
p.(None): 5.14.3. The sponsor should ensure that the written procedures contain the instructions that the investigator / institution needs
p.(None): Observe during testing, handling and storage of the product under test and related documentation. These
p.(None): instructions should include proper and secure admission, handling, storage and dispensing of the subject
p.(None): product, downloading unused test product from respondent and returning it to the sponsor (ie
p.(None): another way to remove unused product if approved by the sponsor, in accordance with applicable law
p.(None): regulations).
p.(None): 5.14.4. The sponsor should:
p.(None): a) ensure timely delivery of the test product to the researcher;
p.(None): b) keep records of the transport, receipt, disposal, return and destruction of the product under test (see
p.(None): 8. Basic documents for conducting the clinical trial);
p.(None): c) provide for a system of return for the product under examination and for recording such a download (e.g.
p.(None): for recall of defective products, returns upon completion of tests, refunds after expiration
p.(None): duration);
p.(None): d) maintains a system for withdrawing unused test product and recording it
p.(None): withdrawals.
p.(None): 5.14.5. The sponsor should:
p.(None): a) take the necessary measures to ensure the stability of the product under test during the period of use;
p.(None): b) have sufficient quantities of the product under test for subsequent confirmation
p.(None): its specifications, if necessary, and keeps the documentation of the analysis and
p.(None): characteristics of the production batch sample. To the extent permitted by the stability of the drug, samples should be kept at or up to
p.(None): completing the analysis of the test results or by the deadline prescribed by applicable law, if required
p.(None): and a longer storage period.
p.(None): 5.15. Access to documentation
p.(None): 5.15.1. The sponsor should ensure that the Protocol or other written agreement states that
p.(None): the researcher / institution must allow direct access to the original data / documents
p.(None): for monitoring, audit, review by the Ethics Committee and inspection by the competent authorities.
p.(None): 5.15.2. The sponsor should determine that each respondent has given his / her written consent for direct access to his / her own
p.(None): original health data for monitoring, audit, review by the Ethics Committee and inspection by
p.(None): by the competent authorities.
p.(None): 5.16. Security information
p.(None): 5.16.1. The sponsor is responsible for the ongoing assessment of the safety of the product being tested.
p.(None): 5.16.2. The sponsor should promptly inform all researchers / institutions and competent authorities of
p.(None): knowledge that may adversely affect the safety of the respondent, the conduct of the examination, or the modification
p.(None): approval / positive opinion of the Ethics Committee.
p.(None): 5.17. Reporting adverse drug reactions
p.(None): 5.17.1. The sponsor should promptly inform all researchers / institutions, Ethics Committees (where applicable)
p.(None): necessary) and the competent authorities of any serious and unexpected adverse reactions to the drug.
p.(None): 5.17.2. These emergency reports should comply with applicable laws and "ICH"
p.(None): Clinical Safety Information Management Guidelines: Definitions and Standards for Urgent Reporting.
p.(None): 5.17.3. The sponsor should submit to the competent authorities all updated and periodic safety reports,
p.(None): in accordance with applicable law.
p.(None): 5.18. Monitoring
p.(None): 5.18.1. Purpose
p.(None): The purpose of monitoring the test is to confirm:
p.(None): a) that the protection of the rights and welfare of the respondents is ensured;
p.(None): b) the accuracy and completeness of the test data and compliance with the original documents;
p.(None): c) the examination is carried out in accordance with the valid approved Protocol and its amendments
p.(None): and amendments, with Good Clinical Practice and applicable legislation.
p.(None): 5.18.2. Monitor selection and qualifications
p.(None): a) The sponsor should provide a monitor,
p.(None): b) The monitor should have the appropriate qualifications and scientific and / or clinical knowledge to perform
p.(None): appropriate monitoring of testing. Monitor qualifications should be documented,
...
p.(None): plan by the researcher / institution, the sponsor should terminate his participation in the
p.(None): examination. When the participation of the researcher / institution is terminated due to discrepancies, the sponsor shall do so
p.(None): it must immediately inform the competent authorities.
p.(None): 5.21. Premature completion or delay of clinical trial
p.(None): If the examination is interrupted or delayed, the sponsor should immediately inform the researcher / institution
p.(None): and the competent authorities and give reasons for termination or delay. Also, sponsor or researcher / institution, depending on
p.(None): current legislation, you should immediately notify the Ethics Committee and provide reasons for termination or adjournment.
p.(None): 5.22. Clinical trial reports
p.(None): Whether the examination is completed or terminated, the sponsor should ensure that a report is prepared and submitted
p.(None): clinical trial to competent authorities in accordance with applicable legal requirements. The sponsor should also provide
p.(None): that clinical trial reports form an integral part of the application for marketing authorization
p.(None): marketed drug, formed according to the "ICH" Guidelines for the Structure and Content of Clinical Trial Reports.
p.(None): (NOTE: The "ICH" guidelines for the structure and content of clinical trial reports allow for abbreviated
p.(None): reports in some cases).
p.(None): 5.23. Multicenter trials
p.(None): For multicenter trials, the sponsor should ensure that:
p.(None): 5.23.1. That all researchers conduct the examination strictly in accordance with the Protocol agreed with
p.(None): sponsored and approved by the competent authorities and, if requested, for which approval / positive opinion exists
p.(None): Ethics Committee.
p.(None): 5.23.2. That the test list form allows you to view all the required information in each center
p.(None): multicenter testing. Those researchers who collect additional data should submit a supplementary test
p.(None): lists whose form also allows additional information to be recorded.
p.(None): 5.23.3. That the duties of the research coordinator and other researchers have been documented before the start of the examination.
p.(None): 5.23.4. That all researchers were given instructions on adhering to the Protocol, adherence to unique standards for
p.(None): evaluation of clinical and laboratory results and completion of test lists.
p.(None): 5.23.5. Simplified communication between researchers.
p.(None): 6. CLINICAL TESTING PROTOCOL AND ITS AMENDMENTS AND APPENDICES
p.(None): The clinical trial protocol should include the sections listed in this chapter. However, data related to
p.(None): the test center may be indicated on the separate pages of the Protocol or laid down in a separate contract,
p.(None): and some of the information below may be part of other documentation, such as the Explorer Booklet.
p.(None): 6.1. General information
p.(None): 6.1.1. The name, number and date of the Protocol. Amendments and additions to the Protocol should also be dated and dated.
p.(None): 6.1.2. Name and address of sponsor and monitor (if monitor address differs from sponsor).
p.(None): 6.1.3. Name and address of the person authorized to sign the Protocol and its amendments and additions on behalf of the sponsor.
p.(None): 6.1.4. Name, title, address and telephone number of sponsor medical expert (medical doctor)
p.(None): or dentist) for examination.
p.(None): 6.1.5. Name and title of researcher responsible for conducting the test and address and telephone number of the test centers.
...
p.(None): Pharmacokinetics and metabolism of the test product in animals
p.(None): Toxicology Action in humans
p.(None): Pharmacokinetics and metabolism of test product in
p.(None): people
p.(None): Safety and efficiency
p.(None): Experiences after placing the test product on the market Summary data and guide for the researcher
p.(None): References: 1) Publications
p.(None): 2) reports
p.(None): References, if any, should be agreed at the end of each chapter.
p.(None): Attachments (if any).
p.(None): 8. BASIC DOCUMENTS FOR CONDUCTING A CLINICAL TEST
p.(None): 8.1. Introduction
p.(None): Basic documents are those documents which, individually or together, enable the assessment of the conduct of the examination
p.(None): and the quality of clinical trial data. These documents serve as proof that
p.(None): researcher, sponsor and monitor adhere to the standards of good clinical practice and all applicable legal regulations.
p.(None): In addition, basic documents play an important role. Completion of basic documents in a timely manner
p.(None): with the researcher / institution and the sponsor can significantly contribute to the successful conduct of the test from
p.(None): by researchers, sponsors, and monitors.
p.(None): In addition, these documents are the most frequent subject of audits by independent evaluators and the inspection of appropriate ones
p.(None): of the competent authorities as part of the procedure to confirm the validity of the tests and the quality of the collected
p.(None): data.
p.(None): No. 19 - Page 66 S L U Ž B E N I G L A S N I K B and H
p.(None): Monday, March 12, 2012
p.(None): Below are lists of basic documents. They are divided into three groups according to the test phase in which
p.(None): are created:
p.(None): 1) before the test begins,
p.(None): 8.2.7. DATED AND DOCUMENTED APPROVAL / POSITIVE OPINION OF ETHICAL
p.(None): Document that X X examination considered
p.(None): Ethics Committee and gave its approval / positive
p.(None): 2) during testing,
p.(None): 3) after completion or termination of testing.
p.(None): The purpose of each document and the place where it should be stored is indicated; with researchers / institutions, sponsors or code
p.(None): both sides. At the beginning of the test, a master test archive should be established with both the researcher / institution and the code
p.(None): sponsors.
p.(None): Closing the research site or completing the clinical trial is only possible when the monitor
p.(None): review all documentation with both the researcher / institution and the sponsor and confirm that all necessary
p.(None): keeps the documentation in appropriate places.
p.(None): All documents referred to in this Regulation shall be subject to inspection by the sponsor or the inspection of appropriate ones
p.(None): competent authorities.
p.(None): 8.2. Before starting a clinical trial
p.(None): COMMITTEES ON THE FOLLOWING: Opinion. Identify
p.(None): version, number and date of each document
p.(None): - protocol and amendments
p.(None): - test sheets
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Respondent engagement ad (if scheduled)
p.(None): - Respondent's fees (if any):
p.(None): - other approved documents
p.(None): At this stage of test planning, the following documents must be prepared, which must be formed beforehand
p.(None): the official start of the examination.
p.(None): 8.2.8. COMPOSITION OF THE ETHICAL COMMITTEE
p.(None): Document that board composition is in accordance with Good Clinical Practice
p.(None): X X (if necessary)
p.(None): The name of the document
p.(None): Purpose
p.(None): Researcher / Institution
p.(None): Sponsor
p.(None): 8.2.9. LICENSE / APPLICATION Document that the COMPETENT AUTHORITY (where the permit / application was obtained
p.(None): X
p.(None): (if
p.(None): X
p.(None): (if
p.(None): 8.2.1. BROCHURE FOR RESEARCHERS
p.(None): Document that X have been submitted to the researcher
p.(None): relevant scientific information on the product tested
p.(None): X is required)
p.(None): 8.2.10. BIOGRAPHIES AND / OR
p.(None): from the competent authority prior to the commencement of the examination, and in accordance with applicable legal regulations
p.(None): needed)
p.(None): X
p.(None): needed)
p.(None): X
p.(None): 8.2.2. SIGNED
p.(None): Document that X
p.(None): X OTHER DOCUMENTS WHICH qualifications and suitability
p.(None): TEST PROTOCOL WITH AMENDMENTS AND TEST LIST EXAMPLE
p.(None): 8.2.3. INFORMATION TO THE RESPONDENTS
p.(None): - INFORMED
p.(None): CONNECTION (including all relevant translations)
p.(None): - OTHER WRITTEN NOTES
...
p.(None): - other validations (where necessary)
p.(None): 8.3.8. DOCUMENTATION ON (See 8.2.15) X X TRANSPORT
p.(None): 8.3. During the examination
p.(None): In addition to the documents listed above, the following table shows the documents that should be created during the course
p.(None): clinical trial as evidence that all new data are documented and presented.
p.(None): TEST PRODUCT AND TEST MATERIAL
p.(None): 8.3.9. NEW SERIES ANALYSIS CERTIFICATES
p.(None): (see 8.2.16.) X
p.(None): The name of the document
p.(None): 8.3.1. AMENDMENTS TO THE RESEARCH BROCHURE
p.(None): Purpose
p.(None): Document that the researcher is informed in a timely manner of the latest data as soon as it is available
p.(None): Researcher / Institution X
p.(None): Sponsor
p.(None): X
p.(None): TESTED
p.(None): PRODUCTS
p.(None): 8.3.10. MONITOR VISIT REPORTS
p.(None): 8.3.11. OTHER COMMUNICATIONS SA
p.(None): Document visits and X findings of the monitor at the center
p.(None): conducting tests
p.(None): Document contracts and X X important discussions related to
p.(None): 8.3.2. ALL CHANGES I
p.(None): Document changes X
p.(None): X CENTER OF ADMINISTRATION administration, violation
p.(None): ADDITIONS:
p.(None): - Protocols and amendments
p.(None): - test sheets
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Ads to include respondents (if planned
p.(None): of the said documents in the examination
p.(None): TESTING
p.(None): - letters / letters
p.(None): - meeting notes
p.(None): - telephone conversation notes
p.(None): 3/8/12 SIGNED
p.(None): the provisions of the Protocol,
p.(None): conducting tests, reporting adverse events
p.(None): Document that X
p.(None): advertising)
p.(None): 8.3.3. DATED AND DOCUMENTED APPROVAL / POSITIVE OPINION OF ETHICAL
p.(None): Document X changes and / or additions
p.(None): reviewed and discussed by the Ethics Committee
p.(None): INFORMED CONSTITUENTS respondent gave his
p.(None): X consent in accordance with
p.(None): Good clinical practice and the Protocol before his
p.(None): COMMITTEES ON THE FOLLOWING: Adopted positively
p.(None): opinion. Identify the number, version and date of each document
p.(None): - Protocol modifications and additions
p.(None): - changes:
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Respondent engagement ads (if scheduled)
p.(None): - other approved documents
p.(None): - test monitoring reports (where applicable)
p.(None): 8.3.4. LICENSE / APPLICATION Document
p.(None): X (if X
p.(None): 3/8/13 ORIGINAL DOCUMENTS
p.(None): 3/8/14 COMPLETED, SIGNED AND DATED TEST SHEETS
p.(None): engaging in testing. In addition document the permission for direct access to the data (see 8.2.3.)
p.(None): Document the existence of the interviewee and prove the integrity of the collected test data, including the original
p.(None): documents related to examination, treatment and medical history
p.(None): Document that the researcher or an authorized member of the research team has verified the information in the test list
p.(None): X
p.(None): X (copy)
p.(None): X
p.(None): (original)
p.(None): THE COMPETENT AUTHORITY, WHERE REQUIRED, TO:
p.(None): - amendments to the protocols and other documents
p.(None): compliance with applicable legislation
p.(None): needed)
p.(None): 3/8/15 DOCUMENTATION Document everything
p.(None): ON THE TEST LIST AMENDMENTS, respectively
p.(None): corrections to the test list after entering the initial data, as well as being signed and dated
p.(None): X (copy) X (original)
p.(None): Issue 19 - Page 68 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 3/8/16 NOTICE OF SERIOUS ADVERSE EVENTS AND
p.(None): Document X
p.(None): notification of the researcher to the sponsor of serious
p.(None): X 8.4. After completion or termination of testing
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.(None): which is used instead of the name of the respondent when the researcher reports adverse reactions and / or others
p.(None): clinical trial data.
p.(None): 1.59. Testing Center
p.(None): The place or institution where the activities related to the clinical trial are conducted.
p.(None): 1.60. An unexpected side effect
p.(None): Reaction to a medicine whose nature, severity or outcome are not known or are not described in the Product Brochure
p.(None): researcher or in the summary of product characteristics, which cannot be expected based on known pharmacological properties
p.(None): drug.
p.(None): 1.61. Vulnerable subjects
p.(None): Individuals whose willingness to participate in a clinical trial may be unjustifiably influenced by expectations,
p.(None): justified or not, that participation will bring them certain benefits, that is, otherwise they will be
p.(None): threaten the elderly or superiors in the event that they refuse to participate. Examples are members
p.(None): hierarchical groups such as medical, pharmacy or dental students, hospital and laboratory
p.(None): personnel, employees of the pharmaceutical industry, members of the military and police forces and prisoners.
p.(None): Among these respondents are patients with incurable diseases, residents of homes for
p.(None): powerless, unemployed and poor people, patients in urgent conditions, ethnic minorities, homeless people,
p.(None): nomads, refugees, minors and persons incapable of giving their consent.
p.(None): 1.62. Respondent safety
p.(None): Physical and mental integrity of the participant in the clinical trial.
p.(None): 2. PRINCIPLES OF GOOD CLINICAL PRACTICE IN CLINICAL TESTING
p.(None): 2.1. Clinical trials should be conducted in accordance with the ethical principles of Helsinki
p.(None): declarations, Good Clinical Practices and applicable legislation.
p.(None): 2.2. Before starting the clinical trial, the risks and disruptions to
p.(None): expected benefits for respondents and society. Clinical trials should only be initiated and conducted if
p.(None): the expected benefit justifies the risk.
p.(None): 2.3. The rights, safety and well-being of the respondents must be above the interests of science and society.
p.(None): 2.4. The intended clinical trial should be supported by appropriate available preclinical and clinical data on
p.(None): test product.
p.(None): 2.5. The clinical trial should be scientifically based, and clearly and thoroughly presented in the Protocol.
p.(None): 2.6. Clinical trials should be conducted in accordance with the Ethics-approved Protocol / Positive Opinion
p.(None): board.
p.(None): 2.7. Nursing care and treatment decisions should always be a responsibility
p.(None): researchers.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): The United States, but also Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
p.(None): These guidelines should be followed when analyzing clinical trial data at the time of submission
p.(None): requests to the competent authorities.
p.(None): The principles set out in these Guidelines may also apply
p.(None): 8.4.4. WITNESS CERTIFICATE Document that X
p.(None): (where available)
p.(None): 8.4.5. FINAL
p.(None): is odit performed Document yes
p.(None): in other clinical trials that may affect safety
p.(None): X and respondent welfare.
p.(None): MONITOR REPORT are all activities in
p.(None): 1. DEFINITIONS
p.(None): ABOUT TESTING COMPLETION
p.(None): 8.4.6. THERAPY GROUPS AND DECISION DOCUMENTATION
p.(None): 8.4.7. FINAL REPORT OF THE RESEARCHER TO THE ETHICAL COMMITTEE AND / OR THE COMPETENT AUTHORITIES
p.(None): 8.4.8. CLINICAL TESTING FINAL REPORT
p.(None): 9. PUBLISHING
p.(None): examination completed, and copies of basic documents kept in appropriate records
p.(None): Returns to the sponsor to document any decryption procedures
p.(None): Document completion of testing
p.(None): Document test results and interpretation
p.(None): X
p.(None): X
p.(None): X X
p.(None): (if necessary)
p.(None): 1.1. Adverse drug reaction
p.(None): Any adverse and unintentionally induced drug reaction that may occur at a therapeutic dose, or
p.(None): administration of the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological
p.(None): function (see "ICH" Clinical Safety Information Management Guidelines: Definitions and Standards for Emergency
p.(None): reporting).
p.(None): The term & quot; drug reaction & quot; means that there is a cause and effect relationship between the drug and the undesired
p.(None): to act at least as a possibility, ie. that it cannot be ruled out.
p.(None): 1.2. Adverse event
p.(None): Any adverse medical event in a clinical trial in a patient or subject
p.(None): who has received a pharmaceutical product and for which there is no need for a cause and effect relationship with the administration of the product
p.(None): to be proved. An adverse event represents any adverse and adverse event (including
p.(None): deviation in laboratory findings), symptom or disease associated with the use of (investigated)
p.(None): product, whether or not it is the cause (see "ICH" Clinical Data Management Guidelines
p.(None): security:
p.(None): These Guidelines shall enter into force on the day of their adoption and shall be published in the Official Gazette of BiH.
p.(None): Chairman of the Expert Council
p.(None): Definitions and standards for emergency reporting).
p.(None): 1.3. Amendments to the Protocol
p.(None): Amendments to the Protocol or formal explanation of the Protocol.
p.(None): No. 10-07.2-1174-1 / 12
p.(None): February 27, 2012
p.(None): Cf. mr ph.
p.(None): Ivan Prlic, s. r.
p.(None): 1.4. Legislation in force (s)
p.(None): Law (s) and regulation (s) relating to the conduct of clinical trials of medicinal products / medical devices.
p.(None): 1.5. Approval (Refers to Ethics Committee)
p.(None): Pursuant to Article 47, paragraph (3) of the Law on Medicines and Medical Devices of Bosnia and Herzegovina
p.(None): (Official Gazette of BiH, No. 58/08), Expert Council of the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.(None): Herzegovina, at the 13th session held on 17.11.2011. at the proposal of the Director of the Agency for Medicinal Products and
p.(None): medical devices of Bosnia and Herzegovina, brings
p.(None): GUIDELINES
p.(None): GOOD CLINICAL PRACTICES IN CLINICAL TESTING
p.(None): INTRODUCTION
p.(None): Good clinical practice (GCP) represents international ethical and scientific
p.(None): quality standards for planning, implementing, monitoring and reporting on
p.(None): Positive decision of the Ethics Committee on clinical trial that it can be conducted at the trial center in accordance with
p.(None): provisions of this committee, institution, Good Clinical Practice and applicable law.
p.(None): 1.6. Odit
p.(None): Systematic and independent review of clinical trial activities and documents to determine if
p.(None): examination conducted, data entered and analyzed and reported in accordance with the Protocol,
p.(None): sponsor standard operating procedures (SOPs), Good Clinical Practice and applicable legal requirements.
p.(None): 1.7. Certificate of Completion
...
p.(None): 3.1.4. The Ethics Committee should conduct continuous monitoring of each ongoing examination, in periods
p.(None): which are appropriate for the risk assessment of the respondents and at least once a year.
p.(None): 3.1.5. The Ethics Committee has the right to request that the respondent be provided with more information than the one indicated in
p.(None): of items 4.8.10. when, in the opinion of the Ethics Committee, such supplementary information
p.(None): No. 19 - Page 54 S L U Ž B E N I G L A S N I K B and H
p.(None): Monday, March 12, 2012
p.(None): can significantly contribute to the protection of the rights, safety and / or well-being of respondents.
p.(None): 3.1.6. When should a non-therapeutic clinical trial be conducted for which legal consent is required
p.(None): (see 4.8.12, 4.8.14), the Ethics Committee should determine whether they are in the proposed Testing Protocol
p.(None): and / or other documentation sufficiently considered ethical issues and whether they meet current legal requirements
p.(None): regulations for such tests.
p.(None): 3.1.7. When the Examination Protocol indicates that it is not possible to obtain the consent of the subjects in a timely manner or
p.(None): of his legal representative (ie in an emergency, see 4.8.15), the Ethics Committee should determine whether
p.(None): the proposed Testing Protocol and / or other documentation sufficiently considered ethical issues and whether
p.(None): meet the applicable legal requirements for such tests.
p.(None): 3.1.8. The Ethics Committee considers the amount and method of payment of reimbursement to respondents to remove
p.(None): the potential for forcible or inappropriate influence on the respondents. Payment of compensation is required
p.(None): distribute in installments, not the full amount upon completion of respondent's participation in
p.(None): examination.
p.(None): 3.1.9. The Ethics Committee should provide payment information to the respondents, including manner, amount and schedule
p.(None): payments, to be defined in the respondent's written consent form, as well as in any other written notice
p.(None): for the respondents. The method of payment in proportionate installments should be indicated.
p.(None): 3.2. Composition, functions and procedures
p.(None): 3.2.1. The ethics committee should be composed of persons who have the appropriate qualifications and experience required for
p.(None): consideration and evaluation of the scientific, medical and ethical aspects of the proposed test. It is recommended that Ethical
p.(None): committee:
p.(None): a) has at least five members;
p.(None): b) at least one member whose sphere of interest is unscientific;
p.(None): c) at least one member independent of the institution or the place where the examination is conducted.
...
p.(None): the route of administration, the dosage, the length of the test and the appropriate population planned for the test.
p.(None): 5.12.2. When significant new information is available, the sponsor should update the Researcher Brochure (see
p.(None): 7.)
p.(None): 5.13. Production, packaging and labeling and coding of the product under test
p.(None): 5.13.1. The sponsor should ensure that the product under study (including, if necessary, a comparative drug)
p.(None): and placebo) characterized according to the stage of its development, to have been produced in accordance with the Good
p.(None): manufacturer's practice, and that it is encrypted and marked in a way that protects the blind process, if any. Besides,
p.(None): labeling should be in accordance with applicable legal regulations.
p.(None): 5.13.2. The sponsor should indicate appropriate storage conditions for the drug such as temperature, protection against influences
p.(None): light, storage time, drug reconstitution procedures and infusion agents as appropriate
p.(None): planned. The sponsor should inform all parties involved (i.e. monitors, researchers,
p.(None): pharmacists, warehouse managers).
p.(None): 5.13.3. The packaging of the test product should be such as to prevent its contamination and
p.(None): unacceptable degree of damage during transport and storage.
p.(None): 5.13.4. In blind tests, the encryption system of the product under test should also contain
p.(None): a mechanism that allows rapid identification of the drug in an emergency but which prevents it from becoming blind
p.(None): interrupts unnoticed.
p.(None): No. 19 - Page 60 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 5.13.5. If significant changes are made to the formulation of the test or comparative product during
p.(None): clinical development, results of any additional formulated drug study (e.g., stability, degree of availability,
p.(None): bioavailability) should be available before using the new formulation in a clinical trial to evaluate that
p.(None): whether such changes would significantly alter the pharmacokinetic profile of the product.
p.(None): 5.14. Delivering and handling the tested product
p.(None): 5.14.1. The sponsor is responsible for delivering the test product to the researcher / institution.
p.(None): 5.14.2. The sponsor does not need to provide the investigator / institution with the product under test until he has all the necessary information
p.(None): documentation (eg approval / positive opinion of the Ethics Committee and competent authorities).
p.(None): 5.14.3. The sponsor should ensure that the written procedures contain the instructions that the investigator / institution needs
p.(None): Observe during testing, handling and storage of the product under test and related documentation. These
p.(None): instructions should include proper and secure admission, handling, storage and dispensing of the subject
p.(None): product, downloading unused test product from respondent and returning it to the sponsor (ie
p.(None): another way to remove unused product if approved by the sponsor, in accordance with applicable law
p.(None): regulations).
p.(None): 5.14.4. The sponsor should:
p.(None): a) ensure timely delivery of the test product to the researcher;
...
p.(None): the researcher / institution must allow direct access to the original data / documents
p.(None): for monitoring, audit, review by the Ethics Committee and inspection by the competent authorities.
p.(None): 5.15.2. The sponsor should determine that each respondent has given his / her written consent for direct access to his / her own
p.(None): original health data for monitoring, audit, review by the Ethics Committee and inspection by
p.(None): by the competent authorities.
p.(None): 5.16. Security information
p.(None): 5.16.1. The sponsor is responsible for the ongoing assessment of the safety of the product being tested.
p.(None): 5.16.2. The sponsor should promptly inform all researchers / institutions and competent authorities of
p.(None): knowledge that may adversely affect the safety of the respondent, the conduct of the examination, or the modification
p.(None): approval / positive opinion of the Ethics Committee.
p.(None): 5.17. Reporting adverse drug reactions
p.(None): 5.17.1. The sponsor should promptly inform all researchers / institutions, Ethics Committees (where applicable)
p.(None): necessary) and the competent authorities of any serious and unexpected adverse reactions to the drug.
p.(None): 5.17.2. These emergency reports should comply with applicable laws and "ICH"
p.(None): Clinical Safety Information Management Guidelines: Definitions and Standards for Urgent Reporting.
p.(None): 5.17.3. The sponsor should submit to the competent authorities all updated and periodic safety reports,
p.(None): in accordance with applicable law.
p.(None): 5.18. Monitoring
p.(None): 5.18.1. Purpose
p.(None): The purpose of monitoring the test is to confirm:
p.(None): a) that the protection of the rights and welfare of the respondents is ensured;
p.(None): b) the accuracy and completeness of the test data and compliance with the original documents;
p.(None): c) the examination is carried out in accordance with the valid approved Protocol and its amendments
p.(None): and amendments, with Good Clinical Practice and applicable legislation.
p.(None): 5.18.2. Monitor selection and qualifications
p.(None): a) The sponsor should provide a monitor,
p.(None): b) The monitor should have the appropriate qualifications and scientific and / or clinical knowledge to perform
p.(None): appropriate monitoring of testing. Monitor qualifications should be documented,
p.(None): c) The monitor should be fully familiar with the product being tested, the Protocol, the written form
p.(None): consent and other written notices intended for respondents, with standard
p.(None): operational procedures and applicable legal regulations.
p.(None): 5.18.3. Scope and nature of monitoring
p.(None): The sponsor should ensure proper monitoring of the trials as well as determine the appropriate one
p.(None): the extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on facts such as
...
p.(None): and monitoring period (if provided).
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): No. 19 - Page 63
p.(None): 6.4.6. Description of criteria for termination or termination of examination for individual respondents, parts of the examination
p.(None): or the entire examination.
p.(None): 6.4.7. Procedures for keeping records of the tested product, including placebo and comparator.
p.(None): 6.4.8. Description of storing randomization codes and procedures for decrypting them.
p.(None): 6.4.9. A description of all data to be entered directly into the test list of respondents (ie without prior written or
p.(None): electronic record) and data considered original.
p.(None): 6.5. Selection and exclusion of respondents
p.(None): 6.5.1. Criteria for inclusion of respondents.
p.(None): 6.5.2. Criteria for excluding respondents.
p.(None): 6.5.3. Criteria for withdrawal of subjects, that is, termination of test product therapy and procedures
p.(None): specifying the following:
p.(None): a) when and how the respondent withdraws from the test / therapy of the test product;
p.(None): b) the type of data required and the time limit for their collection;
p.(None): c) whether these respondents change and how;
p.(None): d) monitoring of subjects who withdraw from testing / therapy with the product under test.
p.(None): 6.6. Respondent therapy
p.(None): 6.6.1. Planned therapy, including names of all products, doses and dosage regimens, route of administration and
p.(None): therapeutic period, including the follow-up period of the subjects for each product and treatment group tested.
p.(None): 6.6.2. Permitted medication, that is, therapy (including emergency therapy) and one that is not
p.(None): allowed before or during the examination.
p.(None): 6.6.3. Procedures for monitoring compliance with the test plan by the respondent.
p.(None): 6.7. Evaluation of efficiency
p.(None): 6.7.1. Determination of efficiency parameters.
p.(None): 6.7.2. Methods and timeframe for estimating, recording and analyzing efficiency parameters.
p.(None): 6.8. Security assessment
p.(None): 6.8.1. Determining security parameters.
p.(None): 6.8.2. Methods and time period for estimating, recording and analyzing security parameters.
p.(None): 6.8.3. Procedures for recording and reporting adverse events and associated diseases.
p.(None): 6.8.4. The manner and length of the follow-up period of the respondent after an adverse event.
p.(None): 6.9. Statistical data
p.(None): 6.9.1. A description of the statistical methods that will be applied, including the time for any planned
p.(None): interanalysis.
p.(None): 6.9.2. Number of planned respondents. In multicenter trials, the planned number should be indicated
p.(None): respondents for each testing center. Reason for choosing a specific sample size (number
p.(None): subjects), including the impact on the significance of the trial and its clinical justification.
p.(None): 6.9.3. The degree of significance that will be used.
p.(None): 6.9.4. Criteria for completing the test.
p.(None): 6.9.5. Procedures for explaining gaps, unused or false information.
p.(None): 6.9.6. Procedures for reporting deviations from the original statistical plan (any
p.(None): deviation from the original statistical plan should be described and explained in the Protocol and / or final
p.(None): report).
p.(None): 6.9.7. Selection of respondents to be included in the analyzes (eg all randomized, received subjects
p.(None): drug tested, eligible subjects, evaluable subjects).
...
p.(None): X X
p.(None): X (if X is required)
p.(None): X
p.(None): X X
p.(None): RIJEKA / TECHNICAL PROCEDURES / TESTS
p.(None): - certificates or
p.(None): - accreditation or
p.(None): - established quality control and / or external control
p.(None): - other forms of validation (where appropriate)
p.(None): 8.2.13. SAMPLE OF THE LABEL TO BE TESTED ON THE TESTED PRODUCT
p.(None): 8.2.14. INSTRUCTIONS FOR MANAGING TEST PRODUCTS AND TEST MATERIALS (if not included in the Protocol or
p.(None): Researcher brochure)
p.(None): 8.2.15. RECORDS OF TRANSPORT OF THE TESTED PRODUCT AND TEST MATERIALS
p.(None): departments / laboratories to perform the predicted tests and confirm the reliability of the findings
p.(None): Document compliance with applicable labeling regulations and the appropriateness of respondent instructions
p.(None): Document the instruction required to properly store, package, distribute, pull and remove the subject
p.(None): products and test materials
p.(None): Document the date of shipment, batch number and method of transport of the test product and test material. Lets
p.(None): monitoring the product series, checking transport conditions and recording inputs and outputs
p.(None): needed)
p.(None): X
p.(None): X X
p.(None): X X
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 67
p.(None): 8.2.16. CERTIFICATE OF ANALYSIS OF THE TESTED PRODUCT
p.(None): 2/8/17 DECCRIPTION PROCEDURES
p.(None): Document the identity, purity and strength of the product under investigation Document the identification method
p.(None): X
p.(None): X X (po
p.(None): need and
p.(None): 8.3.5. BIOGRAPHIES OF NEW RESEARCHERS / SUB-RESEARCHERS
p.(None): 8.3.6. NORMAL SUPPLEMENTS
p.(None): (see 8.2.10.) X X
p.(None): Document that X X normal values and
p.(None): BLIND TESTING of the tested product in
p.(None): emergency, without
p.(None): on the other hand-
p.(None): VALUES / VALUES FOR
p.(None): their ranges are revised during testing
p.(None): 8.2.18. MAIN RANDOMIZATION LIST
p.(None): blindness detection for other subjects Document the randomization method
p.(None): stu)
p.(None): X (if necessary,
p.(None): MEDICAL / LABORATO (see 8.2.11.) RIJEKA / TECHNICAL PROCEDURES / TESTS
p.(None): PROVIDED FOR BY THE PROTOCOL
p.(None): 2/8/19 MONITOR REPORT BEFORE STARTING TEST
p.(None): 8.2.20. REPORT
p.(None): Document that the test site is appropriate (may be combined with 8.2.20.) Document that they are
p.(None): place)
p.(None): X
p.(None): X X
p.(None): 8.3.7. MEDICAL / LABORATES OF ORIGINAL / TECHNICAL PROCEDURES / TESTS
p.(None): - certificates or
p.(None): - accreditation or
p.(None): Document the suitability of tests for the duration of the test (see 8.2.12.)
p.(None): X (if X is required)
p.(None): MONITORS AT THE BEGINNING of the test procedure
p.(None): - established quality control
p.(None): TESTING
p.(None): discussed with the researcher and his associates (may be consolidated with 8.2.19.)
p.(None): and / or external control or
p.(None): - other validations (where necessary)
p.(None): 8.3.8. DOCUMENTATION ON (See 8.2.15) X X TRANSPORT
p.(None): 8.3. During the examination
p.(None): In addition to the documents listed above, the following table shows the documents that should be created during the course
p.(None): clinical trial as evidence that all new data are documented and presented.
p.(None): TEST PRODUCT AND TEST MATERIAL
p.(None): 8.3.9. NEW SERIES ANALYSIS CERTIFICATES
p.(None): (see 8.2.16.) X
p.(None): The name of the document
p.(None): 8.3.1. AMENDMENTS TO THE RESEARCH BROCHURE
p.(None): Purpose
p.(None): Document that the researcher is informed in a timely manner of the latest data as soon as it is available
p.(None): Researcher / Institution X
p.(None): Sponsor
p.(None): X
p.(None): TESTED
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): required reports.
p.(None): 5. SPONSOR
p.(None): 5.1. Quality assurance and control
p.(None): 5.1.1. The sponsor is responsible for the implementation and quality assurance and quality control systems through
p.(None): standard operating procedures, to ensure that conducting a clinical trial, obtaining
p.(None): data, documentation and reporting are in accordance with the Protocol, Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 5.1.2. The sponsor is responsible for contracting with all parties involved to ensure direct access
p.(None): (see 1.21.) all test centers, original data / documents and
p.(None): reports, for the purpose of monitoring and referral by the sponsor and domestic or foreign inspection.
p.(None): 5.1.3. Quality control should be carried out at all levels of data handling in order to ensure their quality
p.(None): reliability and proper processing.
p.(None): 5.1.4. Contracts concluded between sponsors and researchers / institution and other parties
p.(None): those involved in the clinical trial should be in writing as an integral part of the Protocol or as
p.(None): special contract.
p.(None): 5.2. Contracting research organization
p.(None): 5.2.1. The sponsor may delegate all of its obligations or functions or part thereof to a contract research agent
p.(None): organization, but the ultimate responsibility for the quality and integrity of the test results is always borne by the sponsor. Contractual
p.(None): the research organization should meet the requirements of quality assurance and control.
p.(None): 5.2.2. Any obligation and function in connection with the examination, which is delegated and accepted by the contracting authority
p.(None): research organizations, should be stated in writing.
p.(None): 5.2.3. Any examination obligation and function not specifically delegated and accepted by
p.(None): contract research organization, retains sponsor.
p.(None): 5.2.4. Anything in these guidelines that applies to the sponsor applies to the contracting research organization in that sponsor
p.(None): the extent to which the contracting research organization has assumed obligations and functions from the sponsor in relation to
p.(None): by conducting a clinical trial.
p.(None): 5.3. Professional doctoral opinion
p.(None): Medical professionals with appropriate qualifications should be identified, which will always be easy
p.(None): available, to clarify medical issues and resolve test issues. If necessary,
p.(None): the sponsor may also appoint external consultants for this purpose.
p.(None): 5.4. Test plan
p.(None): 5.4.1. The sponsor should, as appropriate, hire qualified persons (eg biostatistical, clinical)
p.(None): pharmacologists and doctors) at all stages of testing, from the development of the Protocol and the test
p.(None): list, through analysis planning, to analyzing and preparing interim and final clinical reports
p.(None): testing.
p.(None): 5.4.2. Explanations regarding the Protocol and amendments to the Protocol are provided in Chapter 6, "ICH"
p.(None): Guidelines for the structure and content of clinical trial reports and other "ICH" guidelines
p.(None): related to test planning, protocol development and testing.
p.(None): 5.5. Test management, data handling and record keeping
p.(None): 5.5.1. The sponsor should appoint appropriately qualified staff to oversee the whole
p.(None): conducting tests, for handling data, for validating data, for conducting statistical analysis
p.(None): and preparing test reports.
...
p.(None): have not been transferred to unauthorized persons;
p.(None): i) confirms that the researcher in the examination includes only those respondents who meet the criteria for
p.(None): participation;
p.(None): j) report on the degree of recruitment of respondents;
p.(None): k) certify that the original documents and other test documentation are correct, complete,
p.(None): and up to date;
p.(None): l) Confirm that the researcher submits all necessary reports, notices and requests;
p.(None): the accuracy, completeness, timeliness, legibility and date of this documentation, as well as their identification
p.(None): testing;
p.(None): m) checks the accuracy and completeness of completing the test sheets, original documentation and other records
p.(None): regarding the examination. The monitor must confirm in particular that:
p.(None): - the data in the test lists required by the Protocol are accurately recorded and in accordance with the data from
p.(None): original documents;
p.(None): - any dose / therapy change is properly documented for each subject;
p.(None): - register adverse events, concomitant therapy and newly emerged illnesses in test lists in
p.(None): in accordance with the Protocol;
p.(None): - Absences of visits of the respondents, non-completed searches and examinations clearly state in the test lists;
p.(None): - All exclusions and drop-outs of respondents are reported and explained in the test lists;
p.(None): n) inform the researcher of any errors, omissions or illegibility of the data in the
p.(None): test lists. The monitor should ensure that appropriate updates are made,
p.(None): amend, delete, and delineate data (if necessary) and initiate researcher or
p.(None): member of the research team authorized to make changes to the test list on behalf of the researcher. This authority should be
p.(None): documented;
p.(None): o) Determines whether adverse events are properly reported and within the timeframe required by Good Clinical
p.(None): practice, Protocol, Ethics Committee, sponsor and applicable law;
p.(None): p) determine the manner in which the basic documentation is kept by the researcher (see 8
p.(None): conducting a clinical trial);
p.(None): r) indicates to the researcher deviations from the Protocol, standard operating procedures, Good
p.(None): clinical practice and applicable law and take appropriate measures to prevent the recurrence of those observed
p.(None): deviations.
p.(None): 5.18.5. Monitoring procedures
p.(None): The monitor should follow the sponsor's written standard operating procedures as well as those
p.(None): procedures specifically established by the sponsor for monitoring the test.
p.(None): 5.18.6. Monitoring report
p.(None): a) The monitor should submit a written report to the sponsor after each visit to the implementation center
p.(None): testing or after any other form of communication related to testing,
p.(None): b) The report should include the date, location, name of the monitor, and the name of the researcher or other person s
p.(None): by which the monitor communicated,
p.(None): c) The report should include a summary of what the monitor viewed and a statement
p.(None): monitors important findings / findings, discrepancies or shortcomings, conclusions, and measures that
p.(None): have been, or should be, taken and / or the measures recommended for the purpose of insurance
p.(None): compliance,
p.(None): d) Review and monitoring of test monitoring reports should be documented by an authorized representative
p.(None): sponsors.
p.(None): 5.19. Odit
p.(None): When conducting an audit, which is part of quality assurance, the sponsor should consider the following:
p.(None): 5.19.1. Purpose gone
...
p.(None): 3) after completion or termination of testing.
p.(None): The purpose of each document and the place where it should be stored is indicated; with researchers / institutions, sponsors or code
p.(None): both sides. At the beginning of the test, a master test archive should be established with both the researcher / institution and the code
p.(None): sponsors.
p.(None): Closing the research site or completing the clinical trial is only possible when the monitor
p.(None): review all documentation with both the researcher / institution and the sponsor and confirm that all necessary
p.(None): keeps the documentation in appropriate places.
p.(None): All documents referred to in this Regulation shall be subject to inspection by the sponsor or the inspection of appropriate ones
p.(None): competent authorities.
p.(None): 8.2. Before starting a clinical trial
p.(None): COMMITTEES ON THE FOLLOWING: Opinion. Identify
p.(None): version, number and date of each document
p.(None): - protocol and amendments
p.(None): - test sheets
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Respondent engagement ad (if scheduled)
p.(None): - Respondent's fees (if any):
p.(None): - other approved documents
p.(None): At this stage of test planning, the following documents must be prepared, which must be formed beforehand
p.(None): the official start of the examination.
p.(None): 8.2.8. COMPOSITION OF THE ETHICAL COMMITTEE
p.(None): Document that board composition is in accordance with Good Clinical Practice
p.(None): X X (if necessary)
p.(None): The name of the document
p.(None): Purpose
p.(None): Researcher / Institution
p.(None): Sponsor
p.(None): 8.2.9. LICENSE / APPLICATION Document that the COMPETENT AUTHORITY (where the permit / application was obtained
p.(None): X
p.(None): (if
p.(None): X
p.(None): (if
p.(None): 8.2.1. BROCHURE FOR RESEARCHERS
p.(None): Document that X have been submitted to the researcher
p.(None): relevant scientific information on the product tested
p.(None): X is required)
p.(None): 8.2.10. BIOGRAPHIES AND / OR
p.(None): from the competent authority prior to the commencement of the examination, and in accordance with applicable legal regulations
p.(None): needed)
p.(None): X
p.(None): needed)
p.(None): X
p.(None): 8.2.2. SIGNED
p.(None): Document that X
p.(None): X OTHER DOCUMENTS WHICH qualifications and suitability
p.(None): TEST PROTOCOL WITH AMENDMENTS AND TEST LIST EXAMPLE
p.(None): 8.2.3. INFORMATION TO THE RESPONDENTS
p.(None): - INFORMED
p.(None): CONNECTION (including all relevant translations)
p.(None): - OTHER WRITTEN NOTES
p.(None): researcher and sponsor agreed on protocols / amendments and test list
p.(None): Document X
p.(None): informed consent
p.(None): Document that X respondent will receive
p.(None): appropriate written
p.(None): TESTIMONY OF RESEARCH / SUB-RESEARCH QUALIFICATIONS
p.(None): 8.2.11. NORMAL VALUES / RANGE
p.(None): X VALUES FOR MEDICAL / LABORATO RIJEKA / TECHNICAL
p.(None): X PROTOCOL PROCEDURES / TESTS
p.(None): 8.2.12.
p.(None): researcher to conduct the test
p.(None): Document normal X X values / ranges
p.(None): test values
p.(None): Document X X
p.(None): notifications based on
p.(None): MEDICAL / LABORATO suitability
p.(None): (if
p.(None): - ADVERTISEMENT TO INCLUDE
p.(None): RESPONDENT (if advertising is planned)
p.(None): 8.2.4. FINANCIAL ASPECTS OF TESTING
p.(None): 8.2.5. INSURANCE STATEMENT (where applicable)
p.(None): 8.2.6. SIGNED CONTRACTS BETWEEN TEST PARTNERS, eg:
p.(None): - researcher / institution and sponsor
p.(None): - the researcher / institution and the contracting research organization
p.(None): - sponsors and contract research organizations
p.(None): - Researchers / Institution and Competent Authorities (where applicable)
p.(None): which can be independently decided to participate in the examination
p.(None): Document that respondent involvement is appropriate and without coercion
...
p.(None): Document that X
p.(None): advertising)
p.(None): 8.3.3. DATED AND DOCUMENTED APPROVAL / POSITIVE OPINION OF ETHICAL
p.(None): Document X changes and / or additions
p.(None): reviewed and discussed by the Ethics Committee
p.(None): INFORMED CONSTITUENTS respondent gave his
p.(None): X consent in accordance with
p.(None): Good clinical practice and the Protocol before his
p.(None): COMMITTEES ON THE FOLLOWING: Adopted positively
p.(None): opinion. Identify the number, version and date of each document
p.(None): - Protocol modifications and additions
p.(None): - changes:
p.(None): - informed consent
p.(None): - other written notices intended for the respondents
p.(None): - Respondent engagement ads (if scheduled)
p.(None): - other approved documents
p.(None): - test monitoring reports (where applicable)
p.(None): 8.3.4. LICENSE / APPLICATION Document
p.(None): X (if X
p.(None): 3/8/13 ORIGINAL DOCUMENTS
p.(None): 3/8/14 COMPLETED, SIGNED AND DATED TEST SHEETS
p.(None): engaging in testing. In addition document the permission for direct access to the data (see 8.2.3.)
p.(None): Document the existence of the interviewee and prove the integrity of the collected test data, including the original
p.(None): documents related to examination, treatment and medical history
p.(None): Document that the researcher or an authorized member of the research team has verified the information in the test list
p.(None): X
p.(None): X (copy)
p.(None): X
p.(None): (original)
p.(None): THE COMPETENT AUTHORITY, WHERE REQUIRED, TO:
p.(None): - amendments to the protocols and other documents
p.(None): compliance with applicable legislation
p.(None): needed)
p.(None): 3/8/15 DOCUMENTATION Document everything
p.(None): ON THE TEST LIST AMENDMENTS, respectively
p.(None): corrections to the test list after entering the initial data, as well as being signed and dated
p.(None): X (copy) X (original)
p.(None): Issue 19 - Page 68 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): 3/8/16 NOTICE OF SERIOUS ADVERSE EVENTS AND
p.(None): Document X
p.(None): notification of the researcher to the sponsor of serious
p.(None): X 8.4. After completion or termination of testing
p.(None): Upon completion or termination of the test, all documentation referred to in sections 8.2. and 8.3. should be guarded,
p.(None): as well as
p.(None): ASSOCIATED REPORTS TO ADVERSE EVENTS i
p.(None): WHICH THE RESEARCH SUPPLIES TO THE SPONSOR
p.(None): 3/8/17 NOTICE
p.(None): related reports in accordance with 4.11.
p.(None): Document
p.(None): X (if X
p.(None): the following documents:
p.(None): Document Title Purpose Researcher / Institution
p.(None): Sponsor
p.(None): SPONSOR / RESEARCH notification
p.(None): needed)
p.(None): 8.4.1. RECORD
p.(None): Document that X X
p.(None): ABOUT THE unexpected unexpected unwanted
p.(None): sponsors / researchers to the competent authorities,
p.(None): INPUTS AND OUTPUTS OF TESTED
p.(None): used the test product in accordance with
p.(None): REACTIONS AND OTHERS
p.(None): that is, the Ethics Committee
p.(None): PRODUCTS IN THE CENTER By protocol and final
p.(None): INFORMATION ON THE SAFETY OF THE MEDICINE SUBMITTED TO AUTHORITIES
p.(None): 3/8/18 NOTICE
p.(None): of unexpected serious adverse reactions and other safety data in accordance with 5.17. and 4.11.1. i
...
General/Other / participants in a control group
Searching for indicator control group:
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p.(None): 1.40. Multicenter clinical trial
p.(None): A clinical trial conducted in accordance with the unique clinical trial protocol in
p.(None): multiple centers and is conducted by multiple researchers, whether the test centers are in the same or
p.(None): different countries.
p.(None): 1.41. Preclinical research
p.(None): Non-human biomedical research.
p.(None): 1.42. Opinion of the Independent Ethics Committee
p.(None): Advice and / or recommendation of the Independent Ethics Committee.
p.(None): 1.43. Original health information
p.(None): See Original data.
p.(None): 1.44. Clinical trial protocol
p.(None): Document describing the objectives, plan, test methodology, method of statistical data processing and
p.(None): organization of testing. The protocol usually contains either an introduction and a rational basis for testing or this may
p.(None): be described by a protocol amendment.
p.(None): 1.45. Changes and additions to the Clinical Trial Protocol
p.(None): Description of the modification of the Clinical Trial Protocol in writing, or its official explanation.
p.(None): 1.46. Quality assurance
p.(None): All planned and systematic activities aimed at ensuring consistency of implementation
p.(None): clinical trial, documenting results and reporting with Good Clinical Practice and applicable law
p.(None): regulations.
p.(None): 1.47. Quality control
p.(None): Operational techniques and quality assurance activities aimed at verifying that they are
p.(None): all the quality requirements related to the test are met.
p.(None): 1.48. Randomization
p.(None): The process of randomly selecting (classifying) subjects into a therapeutic or control group, thereby reducing it
p.(None): researcher bias.
p.(None): 1.49. Competent authorities
p.(None): Bodies competent for the adoption of legislation. For the purposes of these guidelines, the term competent authorities includes bodies which
p.(None): have the regulatory power to legislate including review a submitted clinical
p.(None): documentation and inspection (see 1.29).
p.(None): 1.50. Serious adverse event or serious adverse reaction
p.(None): Any undesirable medical phenomenon related to the health of the subjects causing at any dose:
p.(None): - death,
p.(None): - Immediate threat to life,
p.(None): - requires or extends existing hospitalization,
p.(None): - permanent or significant disability or disability,
p.(None): - congenital anomalies, that is, a birth defect.
p.(None): 1.51. Original data
p.(None): Original medical records from original documents and certified copies of original clinical and laboratory records
p.(None): findings or other results of activities performed during the clinical trial that are required for
p.(None): evaluation of test results.
p.(None): The original information is contained in the original documentation (as originals or certified copies).
p.(None): 1.52. Original documentation
p.(None): Source documents, data and records (e.g., medical history, clinical and administrative records,
p.(None): laboratory findings, memos, subjects' diaries or test lists, drug dispensing records, recorded
p.(None): automated device data, copies and transcripts verified after authentication, negatives,
p.(None): microfilms and magnetic recordings, x-rays, pharmacy records, laboratories and
p.(None): medical-technical services involved in the clinical trial).
...
Searching for indicator placebo:
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p.(None): 1.9. The documentation is gone
p.(None): Documentation allowing monitoring of the course of the clinical trial.
p.(None): 1.10. Clinical trial blindness / masking
p.(None): A process to ensure that one or more parties participating in a clinical trial do not have insight into
p.(None): the respondents' belonging to the treatment groups. A single blind examination means that the respondent,
p.(None): that is, respondents have no insight into belonging to treatment groups, and double-blind to insight into belonging
p.(None): The treatment groups do not have a respondent, ie respondents, a researcher, a monitor, and in some cases, an analyst
p.(None): data.
p.(None): 1.11. Test list
p.(None): Printed, optical or electronic document intended to record all data required by the Protocol
p.(None): a clinical trial reporting the sponsor to each subject.
p.(None): 1.12. Clinical trial
p.(None): Any human test intended to detect or confirm clinical, pharmacological and / or
p.(None): pharmacodynamic effects of the test product and / or adverse reaction identification and / or testing
p.(None): resorption, distribution, metabolism and excretion, with the aim of determining safety and / or efficacy
p.(None): of the tested product.
p.(None): 1.13. Clinical trial report
p.(None): Document a complete clinical trial of any therapeutic, prophylactic or diagnostic efficacy
p.(None): of the drug, which summarizes clinically and statistically significant data, findings and analyzes obtained
p.(None): test results. (see "ICH" Guidelines for the Structure and Content of the Clinical Report
p.(None): examination).
p.(None): 1.14. Comparative product
p.(None): Tested or marketed product (i.e. active control) or placebo to compare drug / medical
p.(None): the product being clinically tested.
p.(None): 1.15. Compliance with the adopted clinical trial plan
p.(None): Compliance with all clinical trial requirements, Good Clinical Practice and applicable legal requirements.
p.(None): 1.16. Confidentiality
p.(None): Preventing the disclosure of proprietary information owned by the sponsor or disclosing the identity of the respondents,
p.(None): except for authorized ones.
p.(None): 1.17. The contract
p.(None): A written, dated and signed contract between two or more parties involved in determining the assignments,
p.(None): delegation and allocation of tasks and responsibilities, and financial matters if necessary. The contract may be based on
p.(None): Protocol.
p.(None): 1.18. Coordination committee
p.(None): A sponsor-based committee to conduct a multicenter clinical trial in concert.
p.(None): 1.19. Researcher Coordinator
p.(None): Researcher responsible for coordinating researchers at different participating multicenter centers
p.(None): examination.
p.(None): 1.20. Contract Research Organization (CRO)
p.(None): A legal or natural person who contracts with a sponsor of a clinical trial based on which of the sponsors
p.(None): assumes all or part of the authorization in the clinical trial.
p.(None): 1.21. Direct access to data
p.(None): Permission to view, analyze, verify and transmit all data and reports relevant to clinical evaluation
p.(None): testing.
p.(None): Any party having direct access to the documentation (eg domestic or foreign authorities, monitors and
p.(None): auditors) is obliged to take all reasonable precautions within the applicable legal provisions in order to preserve
...
p.(None): signed and dated patient informed consent form.
p.(None): 1.29. Inspection
p.(None): Procedure by the competent authorities to carry out an official review of documents, institutions, files and all
p.(None): other information that authorities believe is related to the clinical trial and can be found at the site of the study
p.(None): clinical trial, with sponsors and / or contracting research organizations, or others
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p.(None): Monday, March 12, 2012
p.(None): institutions that the competent authorities deem appropriate for assessment.
p.(None): 1.30. Institution (medical)
p.(None): One or more healthcare facilities where the clinical trial is being conducted.
p.(None): 1.31. Institutional Ethics Committee
p.(None): An independent body made up of medical, scientific or non-scientific members whose responsibility is insurance
p.(None): protection of the rights, safety and well-being of the subjects involved in the clinical trial, among others
p.(None): controlling, approving and ensuring ongoing review of the Clinical Trial Protocol and its annexes,
p.(None): as well as the method for obtaining and documenting the consent of the respondents.
p.(None): 1.32. Clinical trial progress report
p.(None): Report on the results of the clinical trial and their evaluation based on the analysis conducted for
p.(None): a specific period of time during the clinical trial.
p.(None): 1.33. Tested product
p.(None): The pharmaceutical form of the active substance being tested or the placebo with which the test substance is compared,
p.(None): including a product that has a marketing authorization if its use or method (form
p.(None): or packaging) different from the approved one, or, if applicable for an indication that is not approved,
p.(None): or used to obtain new information on an approved application.
p.(None): 1.34. Explorer
p.(None): The person responsible for conducting the clinical trial at the place where it is conducted. If testing on someone
p.(None): The site is run by a research team, the researcher responsible for conducting the clinical trial is
p.(None): principal investigator.
p.(None): 1.35. Researcher / Institution
p.(None): The term "researcher and / or institution" is used if required by applicable regulations.
p.(None): 1.36. Brochure for the researcher
p.(None): A set of clinical and preclinical data on a test product relevant to its testing in humans
p.(None): (see
p.(None): 7. Researcher Brochure).
p.(None): 1.37. Legal representative
p.(None): An individual or a legal or other body empowered by applicable law to give consent on behalf of respondents
p.(None): participation in a clinical trial.
p.(None): 1.38. Monitoring
p.(None): The process of monitoring the clinical trial process and confirming that implementation, documentation, and
p.(None): reporting in accordance with the Clinical Trial Protocol, standard operating procedures, Good
p.(None): clinical practice and applicable law.
p.(None): 1.39. Monitoring report
p.(None): A written report that the monitor submits to the sponsor after each visit to the examination center, as well as a report on
p.(None): any new knowledge regarding testing in accordance with the sponsor's standard operating procedures.
p.(None): 1.40. Multicenter clinical trial
...
p.(None): 5.11.2. If the Ethics Committee requires its approval / positive opinion to modify any aspect of the examination
p.(None): such as amendments to the Protocol, respondent's written consent form, other written notices and / or
p.(None): other procedures intended for respondents, the sponsor must receive a copy from the researcher / institution
p.(None): amendments documents and date of approval / positive opinion of the Ethics Committee.
p.(None): 5.11.3. The sponsor should receive documentation and re-approval dates from the researcher / institution, respectively
p.(None): reassessments with a positive decision of the Ethics Committee as well as withdrawal or delay of approval / positive
p.(None): opinions.
p.(None): 5.12. Tested product data
p.(None): 5.12.1. When planning the test, the sponsor should provide sufficient safety information and
p.(None): drug efficacy from preclinical and / or clinical trials that justify human exposure
p.(None): the route of administration, the dosage, the length of the test and the appropriate population planned for the test.
p.(None): 5.12.2. When significant new information is available, the sponsor should update the Researcher Brochure (see
p.(None): 7.)
p.(None): 5.13. Production, packaging and labeling and coding of the product under test
p.(None): 5.13.1. The sponsor should ensure that the product under study (including, if necessary, a comparative drug)
p.(None): and placebo) characterized according to the stage of its development, to have been produced in accordance with the Good
p.(None): manufacturer's practice, and that it is encrypted and marked in a way that protects the blind process, if any. Besides,
p.(None): labeling should be in accordance with applicable legal regulations.
p.(None): 5.13.2. The sponsor should indicate appropriate storage conditions for the drug such as temperature, protection against influences
p.(None): light, storage time, drug reconstitution procedures and infusion agents as appropriate
p.(None): planned. The sponsor should inform all parties involved (i.e. monitors, researchers,
p.(None): pharmacists, warehouse managers).
p.(None): 5.13.3. The packaging of the test product should be such as to prevent its contamination and
p.(None): unacceptable degree of damage during transport and storage.
p.(None): 5.13.4. In blind tests, the encryption system of the product under test should also contain
p.(None): a mechanism that allows rapid identification of the drug in an emergency but which prevents it from becoming blind
p.(None): interrupts unnoticed.
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p.(None): 5.13.5. If significant changes are made to the formulation of the test or comparative product during
p.(None): clinical development, results of any additional formulated drug study (e.g., stability, degree of availability,
p.(None): bioavailability) should be available before using the new formulation in a clinical trial to evaluate that
...
p.(None): or dentist) for examination.
p.(None): 6.1.5. Name and title of researcher responsible for conducting the test and address and telephone number of the test centers.
p.(None): 6.1.6. Name, title, address and telephone number of the qualified medical doctor (or dentist) responsible for
p.(None): all health decisions related to testing (unless it is a researcher).
p.(None): 6.1.7. Name and address of clinical laboratories and other medical / technical departments and / or
p.(None): institutions involved in the examination.
p.(None): 6.2. Basic information
p.(None): 6.2.1. Name and description of the product tested.
p.(None): 6.2.2. Summary of clinically relevant findings from preclinical studies and relevant clinical findings
p.(None): testing.
p.(None): 6.2.3. Summary of known potential risks and benefits to respondents.
p.(None): 6.2.4. Description and explanation of the route of administration, dosage, dosage regimen and length of therapy.
p.(None): 6.2.5. A statement that the trial will be conducted in accordance with the Clinical Trial Protocol, Good Clinical
p.(None): practice and applicable law.
p.(None): 6.2.6. Description of the respondent population.
p.(None): 6.2.7. References from the literature and data relevant to the test that confirm the rational basis for the test.
p.(None): 6.3. Aims and purpose of the test
p.(None): A detailed description of the objectives and purpose of the test.
p.(None): 6.4. Test protocol
p.(None): The scientific integrity of the test and the credibility of the information obtained in the test depend significantly
p.(None): of the Protocol. The description of the test plan should include:
p.(None): 6.4.1. Detailed description of primary and secondary test objectives.
p.(None): 6.4.2. Description of test type / design (eg double-blind, comparative, placebo-controlled) i
p.(None): schematic diagram of test plan, procedures and phases.
p.(None): 6.4.3. Description of measures taken to avoid bias, including:
p.(None): a) randomization,
p.(None): b) blindness.
p.(None): 6.4.4. Description of therapy, dose and dosage regimen of the test product. This includes a description of the dosage forms,
p.(None): packaging and labeling of the product under test.
p.(None): 6.4.5. Expected duration of participation of respondents in the examination and description and duration of all examination periods, including
p.(None): and monitoring period (if provided).
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p.(None): 6.4.6. Description of criteria for termination or termination of examination for individual respondents, parts of the examination
p.(None): or the entire examination.
p.(None): 6.4.7. Procedures for keeping records of the tested product, including placebo and comparator.
p.(None): 6.4.8. Description of storing randomization codes and procedures for decrypting them.
p.(None): 6.4.9. A description of all data to be entered directly into the test list of respondents (ie without prior written or
p.(None): electronic record) and data considered original.
p.(None): 6.5. Selection and exclusion of respondents
p.(None): 6.5.1. Criteria for inclusion of respondents.
p.(None): 6.5.2. Criteria for excluding respondents.
p.(None): 6.5.3. Criteria for withdrawal of subjects, that is, termination of test product therapy and procedures
p.(None): specifying the following:
p.(None): a) when and how the respondent withdraws from the test / therapy of the test product;
p.(None): b) the type of data required and the time limit for their collection;
p.(None): c) whether these respondents change and how;
p.(None): d) monitoring of subjects who withdraw from testing / therapy with the product under test.
p.(None): 6.6. Respondent therapy
p.(None): 6.6.1. Planned therapy, including names of all products, doses and dosage regimens, route of administration and
p.(None): therapeutic period, including the follow-up period of the subjects for each product and treatment group tested.
p.(None): 6.6.2. Permitted medication, that is, therapy (including emergency therapy) and one that is not
p.(None): allowed before or during the examination.
p.(None): 6.6.3. Procedures for monitoring compliance with the test plan by the respondent.
p.(None): 6.7. Evaluation of efficiency
p.(None): 6.7.1. Determination of efficiency parameters.
p.(None): 6.7.2. Methods and timeframe for estimating, recording and analyzing efficiency parameters.
p.(None): 6.8. Security assessment
p.(None): 6.8.1. Determining security parameters.
p.(None): 6.8.2. Methods and time period for estimating, recording and analyzing security parameters.
...
Orphaned Trigger Words
p.(None): 1.22. Clinical trial documentation
p.(None): All data in any format (including written, electronic, magnetic and optical records and
p.(None): recordings, x-rays, electrocardiograms, etc.) describing or recording methods, and conducting and / or
p.(None): the results of the clinical trial, the factors affecting it, and the measures taken.
p.(None): 1.23. Basic documentation
p.(None): Documents that, individually or together, provide an assessment of the conduct of the clinical trial and the quality
p.(None): the data obtained (see 8. Basic documents for conducting the clinical trial).
p.(None): 1.24. Good clinical practice
p.(None): Good Clinical Practice (GCP) is an international ethical and scientific system
p.(None): the quality of planning, performing, recording, monitoring and reporting on clinical trial at
p.(None): people, which enables the credibility of the information obtained during the examination and protection of rights
p.(None): and the safety of the respondent in accordance with the Declaration of Helsinki on the Protection of Patients' Rights (u
p.(None): (hereinafter referred to as the Declaration of Helsinki).
p.(None): 1.25. Independent Data Monitoring Committee
p.(None): An independent data monitoring committee may establish a sponsor in order to conduct a periodic assessment of the clinical course
p.(None): tests, safety data and key performance conclusions, and which he recommends
p.(None): sponsor continuation, modification, or termination of clinical trial.
p.(None): 1.26. An impartial witness
p.(None): A person independent of the clinical trial who cannot be influenced by the people involved in the clinical trial,
p.(None): which is present in the process of giving informed consent if the respondent or his legal representative does not
p.(None): can read, and who reads to the respondent any written notice for the respondent.
p.(None): 1.27. Ethics Committee
p.(None): An independent advisory body responsible for evaluating the validity of a clinical trial,
p.(None): as well as the ability to conduct a clinical trial according to the principles of Good Clinical Practice, and all
p.(None): this to ensure and protect the rights, safety and well-being of the subjects involved in the clinical
p.(None): examination.
p.(None): The legal status, composition, activities and regulations of the Ethics Committees may vary from country to country,
p.(None): but they must certainly allow the Ethics Committee to act in accordance with the Good Clinical Practice described in these
p.(None): guidelines.
p.(None): 1.28. Informed consent
p.(None): The process by which the respondent voluntarily confirms his / her willingness to participate in a particular clinical
p.(None): examination, having previously been informed of all aspects of the clinical trial that may be affected
p.(None): to the decision to participate. The informed consent of the informed respondent shall be documented by written,
p.(None): signed and dated patient informed consent form.
p.(None): 1.29. Inspection
p.(None): Procedure by the competent authorities to carry out an official review of documents, institutions, files and all
p.(None): other information that authorities believe is related to the clinical trial and can be found at the site of the study
p.(None): clinical trial, with sponsors and / or contracting research organizations, or others
p.(None): Issue 19 - Page 52 S L U Ž B E N I G L A S N I K B i H
p.(None): Monday, March 12, 2012
p.(None): institutions that the competent authorities deem appropriate for assessment.
p.(None): 1.30. Institution (medical)
p.(None): One or more healthcare facilities where the clinical trial is being conducted.
p.(None): 1.31. Institutional Ethics Committee
p.(None): An independent body made up of medical, scientific or non-scientific members whose responsibility is insurance
p.(None): protection of the rights, safety and well-being of the subjects involved in the clinical trial, among others
p.(None): controlling, approving and ensuring ongoing review of the Clinical Trial Protocol and its annexes,
p.(None): as well as the method for obtaining and documenting the consent of the respondents.
p.(None): 1.32. Clinical trial progress report
...
p.(None): Good clinical practice. Statistically controlled sampling may be an acceptable method of data selection
p.(None): to check.
p.(None): 5.18.4. Duties of the monitor
p.(None): In accordance with the requirements of the sponsor, the monitor should ensure that the test is properly conducted and documented in
p.(None): the testing center, carrying out the following test-related activities or the testing center:
p.(None): a) acts as the main line of communication between sponsors and researchers;
p.(None): Monday, March 12, 2012 S L U Ž B E N I G L A S N I K B i H
p.(None): Issue 19 - Page 61
p.(None): b) confirm that the researcher has the appropriate qualifications and capabilities (see 4.1, 4.2;
p.(None): 5.6.), Which remain appropriate during the test and are appropriate for the premises, laboratories, equipment and personnel
p.(None): requirements for the safe and proper conduct of the test during the test period;
p.(None): c) certify for the product under test:
p.(None): - that storage times and conditions are acceptable and that there is sufficient quantity to carry out
p.(None): testing;
p.(None): - the test product is given exclusively to test subjects and doses are administered
p.(None): as defined in the Protocol;
p.(None): - that the respondents were given appropriate instructions for proper administration, handling, storage and return
p.(None): test product;
p.(None): - that the download, use and return of the test product at the test site is controlled and
p.(None): appropriately document;
p.(None): - that the disposal of the unused test product at the test center is in accordance with
p.(None): applicable laws and regulations of the sponsor;
p.(None): d) Confirm that the researcher has complied with the approved Protocol and any approved amendments;
p.(None): e) confirm that the written consent of the respondent was obtained before the respondent was included in the examination;
p.(None): f) confirm that the researcher has received a valid Brochure for the researcher, all documentation as well as
p.(None): other necessary for the proper conduct of the examination, in accordance with the applicable legal regulations;
p.(None): g) ensure that the investigator and the research team are well informed of the examination;
p.(None): h) confirm that the investigator and the research team carry out the specified testing functions in accordance with the Protocol
p.(None): and other written agreement between the sponsor and the researcher / institution and that these functions
p.(None): have not been transferred to unauthorized persons;
p.(None): i) confirms that the researcher in the examination includes only those respondents who meet the criteria for
p.(None): participation;
p.(None): j) report on the degree of recruitment of respondents;
p.(None): k) certify that the original documents and other test documentation are correct, complete,
p.(None): and up to date;
p.(None): l) Confirm that the researcher submits all necessary reports, notices and requests;
p.(None): the accuracy, completeness, timeliness, legibility and date of this documentation, as well as their identification
p.(None): testing;
p.(None): m) checks the accuracy and completeness of completing the test sheets, original documentation and other records
p.(None): regarding the examination. The monitor must confirm in particular that:
p.(None): - the data in the test lists required by the Protocol are accurately recorded and in accordance with the data from
p.(None): original documents;
p.(None): - any dose / therapy change is properly documented for each subject;
p.(None): - register adverse events, concomitant therapy and newly emerged illnesses in test lists in
p.(None): in accordance with the Protocol;
...
p.(None): making an objective assessment of the propriety of the proposed examination based on the assessment of the relationship
p.(None): risks and profits. For this reason, in general, the development of a Researcher Brochure should be medically involved
p.(None): qualified person, but the content may only be approved by medical professionals in the field to which the data relate.
p.(None): These Guidelines set out only a minimum of the information that should be contained in the Prospectus Booklet and propose it
p.(None): appearance. The type and extent of information available is expected to depend on the stage of development of the product under study.
p.(None): If the test product is already on the market and its pharmacological properties are generally known to doctors, it is not
p.(None): an extensive Researcher Brochure required. If authorized by the competent authorities, appropriate replacement for the Brochure
p.(None): may be basic information about the product under study and the text of the package leaflet provided that
p.(None): include valid, comprehensive and detailed information on all aspects of the product under examination that may be relevant
p.(None): researchers. If a new use of the tested product is authorized (eg new
p.(None): indication), a Brochure specific to this new application should be prepared. The brochure should be reviewed at least once
p.(None): annually, and if necessary audited in accordance with the sponsor's written procedures. More frequent controls can be
p.(None): needed depending on the stage of development and new important information. However, new information can be so important
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p.(None): Monday, March 12, 2012
p.(None): that - adhering to Good Clinical Practice - before being included in the revised Brochure, it should be considered with
p.(None): researchers, the Ethics Committee and / or competent authorities.
p.(None): It is the sponsor's duty to make available to the researchers an updated Researcher's Brochure, a
p.(None): the researchers are responsible for submitting the updated Brochure to the Ethics Committee. In case the examination sponsors
p.(None): researcher, sponsor-researcher should determine if it is possible to obtain the Brochure from the manufacturer. If examined
p.(None): the product is provided by the sponsor-researcher, then he is required to provide the necessary information to the participating personnel
p.(None): examination. In cases where it is not practical to produce an official Brochure, the sponsor-researcher should
p.(None): replacement of the introductory part of the Test Protocol, which contains a minimum of current information described in these guidelines.
p.(None): 7.2. General provisions
p.(None): The booklet for the researcher should include:
p.(None): 7.2.1. Front page
p.(None): The front page should include the name of the sponsor, the product tested (i.e., the research number,
p.(None): chemical name, generic name - INN, registered name if applicable and legally possible) and date of issue
p.(None): Brochures. The number of the Brochures valid until then, the date and number of the issue being replaced, are also indicated. Example for the cover
p.(None): see Appendix 1 (see 7.4).
p.(None): 7.2.2. Privacy Statement
p.(None): The sponsor may include a statement requesting the researcher to consider the Brochure a confidential document
p.(None): which can only be made available to the research team, the Ethics Committee and the competent authorities.
p.(None): 7.3. Content of Researcher Brochure
p.(None): The booklet should include the following chapters, documented by available literature data
p.(None): (references):
p.(None): 7.3.1. Content
p.(None): An example of the content is given in Appendix 2 (see 7.5).
p.(None): 7.3.2. Summary
p.(None): A brief summary (preferably no longer than two pages) should be provided, listing the most important ones available
p.(None): information on physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic,
p.(None): metabolic traits and available clinical data relevant to a particular phase of clinical development
p.(None): of the tested product.
p.(None): 7.3.3. Introduction
p.(None): Briefly state the chemical name of the product under test (generic name - INN and protected name, if
p.(None): all active ingredients, the pharmacological group to which it belongs and the expected indications for
p.(None): prophylaxis, treatment and diagnosis. Finally, a general approach to assessment should be defined in the introduction
p.(None): of the tested product.
p.(None): 7.3.4. Physico-chemical and pharmaceutical properties and formulation of the product
p.(None): The substances that make up the test product (including chemical and / or structural) should be described
p.(None): formulas) and a brief overview of the major physical, chemical and pharmaceutical properties.
p.(None): In order to be able to take appropriate precautionary measures during testing, the formulations,
p.(None): including excipients and justify their use where clinically relevant. Also, it should be stated
p.(None): instructions for storing and handling certain pharmaceutical forms.
p.(None): Any structural similarity to other known preparations should be indicated.
p.(None): 7.3.5. Preclinical trials
...
p.(None): as well as
p.(None): ASSOCIATED REPORTS TO ADVERSE EVENTS i
p.(None): WHICH THE RESEARCH SUPPLIES TO THE SPONSOR
p.(None): 3/8/17 NOTICE
p.(None): related reports in accordance with 4.11.
p.(None): Document
p.(None): X (if X
p.(None): the following documents:
p.(None): Document Title Purpose Researcher / Institution
p.(None): Sponsor
p.(None): SPONSOR / RESEARCH notification
p.(None): needed)
p.(None): 8.4.1. RECORD
p.(None): Document that X X
p.(None): ABOUT THE unexpected unexpected unwanted
p.(None): sponsors / researchers to the competent authorities,
p.(None): INPUTS AND OUTPUTS OF TESTED
p.(None): used the test product in accordance with
p.(None): REACTIONS AND OTHERS
p.(None): that is, the Ethics Committee
p.(None): PRODUCTS IN THE CENTER By protocol and final
p.(None): INFORMATION ON THE SAFETY OF THE MEDICINE SUBMITTED TO AUTHORITIES
p.(None): 3/8/18 NOTICE
p.(None): of unexpected serious adverse reactions and other safety data in accordance with 5.17. and 4.11.1. i
p.(None): other safety related information in accordance with 5.16.2.
p.(None): Document X
p.(None): TESTING
p.(None): X
p.(None): records of inputs and outputs of the test product: how much was delivered to the test site, how much
p.(None): distributed to respondents, how much returned from respondents, how much returned to the sponsor
p.(None): SPONSORS RESEARCH for safety information
p.(None): 8.4.2. DOCUMENTATION Document the destruction
p.(None): X (if X
p.(None): ABOUT SAFETY
p.(None): 3/8/19 PERIODIC OR ANNUAL REPORTS TO THE ETHICAL COMMITTEE AND AUTHORITIES
p.(None): 3/8/20 RECORD OF SELECTION OF EXAMINERS
p.(None): 8.3.21. RESPONDENT IDENTIFICATION LIST
p.(None): 8.3.22. RECORD
p.(None): provided by the sponsor to the researcher in accordance with 5.16.2.
p.(None): Periodic or annual reports to the Ethics Committee in accordance with 4.10. and competent authorities in accordance with 5.17.3.
p.(None): Document the identity of the subjects selected for screening before the examination begins
p.(None): Document that the researcher / institution keeps a confidential list of the names of all respondents with the assigned number under which they are
p.(None): involved in the examination and to enable the researcher / institution to determine the identity of each respondent
p.(None): Document chronologically
p.(None): X X (if necessary)
p.(None): X X (if necessary)
p.(None): X
p.(None): X
p.(None): ON THE DESTRUCTION OF THE TESTED PRODUCT
p.(None): 8.4.3. LIST WITH RESPONDENTS IDENTIFICATION CODES
p.(None): 8.4.4. AUDIT CERTIFICATE (where available)
p.(None): 8.4.5. FINAL MONITOR REPORT ON EXAMINATION COMPLETION
p.(None): 8.4.6. THERAPY GROUPS AND DECISION DOCUMENTATION
p.(None): unused test products at the test center or sponsored by Enable identification
p.(None): all respondents who participated in the examination for the purpose of monitoring them. The list should be kept confidential at
p.(None): the agreed time period
p.(None): Document that the odit was performed
p.(None): Document that all testing activities have been completed and that copies of basic documents are kept in appropriate
p.(None): scriptures
p.(None): Returns to the sponsor to document any decryption procedures
p.(None): destroyed at the site of the test) X
p.(None): X X
p.(None): X
p.(None): RESPONDENTS INCLUDED respondents' entry into
p.(None): 8.4.7. FINAL
p.(None): Document the completion of X
p.(None): IN TESTING
p.(None): 8.3.23. RECORDING OF INPUTS AND OUTPUTS OF THE TESTED PRODUCT IN THE TEST CENTER
p.(None): 8.3.24. LIST WITH SIGNATURES
p.(None): examination according to their assigned number
p.(None): Document the use of the X test product
p.(None): in accordance with the Protocol
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| coerce | Presence of Coercion |
| control group | participants in a control group |
| dependence | Drug Dependence |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| elderly | Elderly |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| healthy volunteers | Healthy People |
| homeless | Homeless Persons |
| ill | ill |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| nomads | nomad |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| police | Police Officer |
| poor | Economic/Poverty |
| prisoners | Criminal Convictions |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| unemployed | Unemployment |
| union | Trade Union Membership |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| placebo | ['controlXgroup'] |
| substance | ['drug', 'influence'] |
Trigger Words
consent
ethics
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input