0A4F4F9BD490A749D5437F821CF06DF1
Regulation about Clinical testing of IMP and Medical Devices (2010)
http://www.almbih.gov.ba/_doc/regulative/pravilnik_klinicka_bos.pdf
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| 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
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p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
p.000004: (4) Agency or Entity Ministries of Health or Department of Health of the Brcko District, other state or
p.000004: the entity ministry or other legal entity may require a clinical trial of the medical device for use
p.000004: protection of population health.
p.000004: (5) The costs of testing shall be borne by the proponent of the clinical trial only if it is demonstrated that the safety is effective
p.000004: and the compliance of the medical device with the general and special requirements is in accordance with the provisions of the Act and the regulations adopted on
p.000004: based on it.
p.000004: (6) If it is proved that the safety, efficacy and compliance of the medical device with the general and specific requirements do not
p.000004: in accordance with the provisions of the Act and the regulations adopted thereunder, the costs of the clinical trial shall be borne by the manufacturer
p.000004: that is, the importer of the medical device.
p.000004: Article 39
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Political / criminal
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p.000004: "A doctor will only act in the interests of the patient when he provides medical assistance that can improve
p.000004: the physical and mental state of the patient. "
p.000004: The purpose of biomedical testing in humans must be to repair diagnostic, therapeutic and
p.000004: prophylactic activity and understanding of the etiology and pathogenesis of the disease.
p.000004: In today's medical practice, most diagnostic therapeutic and prophylactic procedures involve risk. That
p.000004: in particular biomedical testing.
p.000004: Medical progress is based on testing, which ultimately rests partly on human testing.
p.000004: In biomedical testing one should be aware of the basic difference between a medical trial with a
p.000004: diagnostic or therapeutic goal for the patient and medical examination where the primary goal is only
p.000004: scientific without containing direct diagnostic or therapeutic values for the person who is the subject of the test.
p.000004: In conducting tests that may affect the environment and welfare of animals that are
p.000004: used for testing should be especially careful.
p.000004: Given that it is unusually important that the results of laboratory testing be applied to people for the improvement of knowledge and
p.000004: assistance to humanity suffering from the World Association of Physicians has prepared the following recommendations as guidelines
p.000004: to every physician in biomedical testing on humans. Recommendations should be constantly refined. It has to
p.000004: emphasize that these standards must only serve as a guide for the world's physicians. Their doctors are not
p.000004: exempt from criminal, civil or ethical liability within the law of their countries.
p.000004: I Basic principles
p.000004: 1. Biomedical testing on humans must be in accordance with generally accepted scientific principles and must be
p.000004: be based on appropriate laboratory and animal testing and good testing
p.000004: knowledge of scientific literature.
p.000004: 2. The design and conduct of any human test must be clearly formulated in a test plan
p.000004: to be subjected to analysis, discussion and guidance by a specially appointed commissioner independent of the examiner with
p.000004: provided that such an independent commission complies with the laws and regulations of the country where the examination is being conducted.
p.000004: 3. Biomedical testing on humans must only be carried out by scientifically qualified personnel and under clinical supervision
p.000004: competent medical professional. Responsibility for the respondent must always lie with the medically qualified person,
p.000004: never to the respondent even though he gave his consent.
p.000004: 4. Medical testing on humans should not be conducted until the importance of its goal is proportionate to the danger to
p.000004: respondents.
p.000004: 5. Each biomedical human test must be preceded by an assessment of foreseeable hazards
p.000004: giving birth with predictable benefits to the respondent or others. Respondent care must always take priority over
p.000004: interests of science and society.
p.000004: 6. The right of the respondent to protect his or her integrity must always be respected. Every precaution should be taken for
p.000004: protecting the subject and reducing the impact of the examination on his physical and mental integrity and his personality in
p.000004: as a whole.
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Health / Drug Usage
Searching for indicator drug:
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p.000004: no. 58/08), at the proposal of the Expert Council of the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, Ministry
p.000004: of Bosnia and Herzegovina brings civil affairs
p.000004: RULEBOOK
p.000004: ON CLINICAL TESTING OF MEDICINES AND MEDICINAL PRODUCTS
p.000004: PART ONE - INTRODUCTORY PART
p.000004: Article 1
p.000004: (Subject of the Rules)
p.000004: (1) This Rulebook regulates the field of clinical trial of a medicinal product and a medical device in Bosnia and Herzegovina:
p.000004: the clinical trial procedure for the medicinal product and the medical device, the obligations of the participants in the clinical trial procedure
p.000004: medication and record keeping in the clinical trial procedure. In the preparation of the clinical trial, they must be determined
p.000004: goals, problems as a risk-benefit balance, and whether the solutions selected are scientifically and ethically justified.
p.000004: According to the provisions of the Declaration of Helsinki contained in Annex No. VI of these Regulations and International Ethical Guidelines
p.000004: biomedical testing on humans issued by the Council for International Organizations of Medical Sciences
p.000004: International Organizations of Medical Sciences-CIOMS), clinical trials must be conducted in accordance with baseline
p.000004: ethical principles: voluntariness; respect for rights; respect for the person; benevolence and harmlessness.
p.000004: (2) The precondition for clinical trial is preclinical trials which provide sufficient evidence of eligibility
p.000004: potential harm and possible clinical use of the drug.
p.000004: (3) Prior to testing, monitoring and control methods and standard operating procedures should be established.
p.000004: Article 2
p.000004: (Definitions)
p.000004: The terms used in this Regulation shall have the following meanings:
p.000004: a) Good clinical practice is a set of internationally recognized ethical and professional standards related to quality
p.000004: planning, performing, documenting and reporting on clinical trials performed on humans, which
p.000004: ensure the protection of the rights, safety and well-being of the subjects as well as the credibility of the results of clinical trials;
p.000004: b) Respondent documentation is documentation prepared in accordance with the clinical trial plan and contains information on
p.000004: one subject collected during the clinical trial;
p.000004: c) Pharmacogenomics is a study of variations in DNA and RNA characteristics related to a given drug response;
p.000004: d) Pharmacogenetics is a branch of pharmacogenomics and is defined as a study of variations in DNA strand sequences related to
p.000004: drug response;
p.000004: e) Pharmacodynamics is the study of the interaction between a drug and its molecular targets;
p.000004: f) Genes are functional segments of genetic material that serve as a schematic blueprint for protein synthesis;
p.000004: g) A genome is the total genetic material of an organism;
p.000004: h) The Institutional Ethics Committee is an independent, advisory body whose duty is to evaluate the justification
p.000004: clinical trial, as well as the possibility of conducting a clinical trial according to the principles of Good Clinical Practice, and all
p.000004: this to ensure and protect the rights, safety and well-being of the subjects involved in the clinical trial;
p.000004: i) The examiner is the person responsible for conducting the clinical trial in the institution where it is conducted;
p.000004: j) The Principal Investigator is the investigator who is responsible for conducting the clinical trial of the medicinal product if clinical
p.000004: drug testing is conducted by the research team;
p.000004: k) The applicant is a person who participates in the clinical trial as a beneficiary of the investigational medicinal product
p.000004: the drug in the trial compares or placebo;
p.000004: l) Clinical Trial Report is a written report of the course of a clinical trial of any therapeutic,
p.000004: a prophylactic or diagnostic product, comprising clinical and statistical data processing, presentation, analysis and
p.000004: conclusions;
p.000004: m) Single or double blind examination means that the candidate does not know what he is receiving or that he does not
p.000004: the respondent, the examiner, or the competent observer do not know what anyone has received.
p.000004: n) Data coding categories
p.000004: Single-coded data and samples are marked with one specific code and do not imply any personal information
p.000004: identifiers. In the case of single coding, data or samples can be linked to a specific person
p.000004: using the encryption key. The clinical investigator is responsible for keeping the coding key. Since the samples and
p.000004: supporting information can be indirectly linked to the research subject, using a coding key, can be taken
p.000004: procedures such as drawing a sample or returning individual results at the request of the subject. Single use
p.000004: coded data and samples allows clinical monitoring, monitoring of the subject or supplementing of the subject's data.
p.000004: Single coding is currently the standard used in clinical research and offers an additional guarantee of
p.000004: subject identifiers, in relation to the general principles of trust in the health care system and privacy protection in
p.000004: daily medical practice;
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p.000004: subjects and unique codes are then deleted. Once a connection has been deleted, it is no longer possible to associate data and samples with
p.000004: to people via encryption keys. "Anonymization" prevents the subject from being re-identified. Since being "anonymized"
p.000004: samples and relevant data cannot relate to the subject. It is not possible to undertake procedures such as sample withdrawal
p.000004: or the return of individual results even at the request of the subject. The use of anonymized data and samples does not allow
p.000004: clinical monitoring, monitoring the subject or adding new data. By deleting the encryption keys that bind the data
p.000004: and specimens with personal information about the subject are provided with additional confidence and privacy protection as this is prevented
p.000004: reidentification of the subject using keys. Anonymous data and samples are never marked with personal information when
p.000004: they collect, nor does the coding key be generated.
p.000004: Therefore, there is no possibility of linking genomic data and samples with individual subjects. In some cases only
p.000004: limited clinical information may be associated with anonymous samples (e.g., samples from diabetic subjects, men,
p.000004: age 50-55 g., cholesterol> mg / dl). Because anonymous samples and relevant data cannot be associated with subjects,
p.000004: it is not possible to undertake procedures such as sample withdrawal, return of individual results, even at the request of the subject.
p.000004: The use of anonymous data and samples does not permit clinical monitoring, monitoring of the subject or supplementation of the data;
p.000004: o) Clinical trial of a drug is any systematic trial of a drug with the aim of finding or confirming it
p.000004: actions, as well as the identification of any side effects of did medication. The clinical trial of the drug includes i
p.000004: clinical part of the study of the bioavailability and bioequivalence of a medicinal product with the aim of determining its effectiveness i
p.000004: harmlessness
p.000004: p) Final Report, Clinical Trial Completion Report, contained in Annex No. IV to this Ordinance
p.000004: presents a detailed description of the test after completion and includes a description of the test methodology, method
p.000004: statistical data processing, description of respondents, presentation and evaluation of statistical analysis results, and critical, ethical,
p.000004: statistical and clinical evaluation of the whole trial;
p.000004: q) Quality control means operational techniques and activities undertaken within the assurance system
p.000004: quality, in order to confirm that all the quality requirements have been met;
p.000004: r) Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and
p.000004: continuously produce and control according to appropriate quality standards in accordance with their purpose;
p.000004: s) Multicenter clinical trial is a clinical trial conducted according to a single protocol
p.000004: a multi-center clinical trial run by multiple examiners, with the centers where the tests are being conducted
p.000004: may be located in one or more countries;
p.000004: t) Surveillance is a systematic test conducted (as a rule on a randomly selected sample of data) by a trained person.
p.000004: which does not directly participate in the trial in order to determine whether the clinical trial in question is being conducted according to
p.000004: approved plan
p.000004: trials, in accordance with standard operating procedures and Good Clinical Practice. It is monitored by the monitor it has
p.000004: appropriate qualifications to perform clinical trial monitor jobs and have good clinical education
p.000004: practice;
p.000004: u) Competent observer is a qualified person who independently assesses the conformity of all on behalf of the contracting authority
p.000004: activities related to clinical trial, protocol, standard operating procedures, Good
p.000004: clinical practice and with applicable regulations;
p.000004: v) The client of the trial is the legal entity at whose request the clinical trial is conducted;
p.000004: w) Adverse drug action is any adverse and unintentionally triggered reaction that may occur during a therapeutic
p.000004: dose of the drug. A side effect of a drug can also be defined as any adverse reaction to a drug that has been administered
p.000004: at the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological functions, with
p.000004: the condition that there is a cause and effect relationship, or that relationship cannot be ruled out;
p.000004: x) Adverse drug reaction in a clinical trial is an undesirable and unintentionally induced reaction in a subject,
p.000004: which may occur in a clinical trial of a drug in connection with any dose of the drug;
p.000004: y) An unexpected side effect of a drug is one that has an unknown nature, severity or outcome,
p.000004: that is, they are not described in the Summary of Product Characteristics and Package Leaflet, or are not part of this effect
p.000004: current knowledge of the drug;
p.000004: z) Adverse event in clinical trial is an unwanted experience (any adverse and undesirable sign such as
p.000004: abnormal laboratory result, symptoms, or disease in the trial) that occurred during the clinical
p.000004: drug testing, whether or not it has a causal relationship to drug use;
p.000004: aa) Other respondent documentation includes hospital records, specialist examination findings and / or
p.000004: special information about the respondent that allows to determine the authenticity of the information in the test lists of respondents and
p.000004: if necessary, allow them to be supplemented and corrected;
p.000004: bb) Clinical trial quality assurance includes the quality assurance systems and procedures in place
p.000004: conducting trials and obtaining data in accordance with Good Clinical Practice, including rules on ethical and
p.000004: professional implementation of standard operating procedures, reporting and qualification of professional staff;
p.000004: cc) A serious adverse reaction in a clinical trial is an undesirable and unintentionally induced reaction to
p.000004: drug in a clinical trial that results in death, imminent life-threatening, disability,
p.000004: hospital treatment (which was not previously required), an extension of hospital treatment or congenital anomaly,
p.000004: that is, birth defects and after birth;
p.000004: dd) A serious adverse event in a clinical trial is an adverse experience that occurred during the clinical trial
p.000004: drug testing, whether or not it has a causal connection with the use of the drug, resulting in death
p.000004: life-threatening, disability, hospital treatment (if not required before), hospital extension
p.000004: treatment, congenital anomalies, or defect at and after birth, or malignancy during the test;
p.000004: ee) Post-marketing intervention clinical trial is a prospective trial in which the drug is administered
p.000004: apply in accordance with the conditions specified in the marketing authorization, which requires additional
p.000004: diagnostic procedures as well as monitoring procedures defined by the clinical trial protocol;
p.000004: ff) Post-marketing non-interventional clinical trial (pharmacoepidemiological study) is a trial
p.000004: in which the drug is administered in accordance with the conditions set out in the marketing authorization of the choice
p.000004: Patients are not predetermined by the clinical trial protocol but fall into current established practice
p.000004: The prescribing is clearly separate from the decision to enroll the patient in the trial. Extra
p.000004: diagnostic or monitoring procedures are not applied and the results obtained are analyzed epidemiologically
p.000004: methods;
p.000004: gg) Test protocol is a document containing the objective, plan and methodology of the test, the method of statistical processing
p.000004: clinical trial data and organization, in accordance with Good Clinical Practice;
p.000004: hh) Respondent's consent is the written statement of the respondent, parent of a minor child, guardian or legal representative,
p.000004: by which he voluntarily confirms his willingness to participate in a particular clinical trial, whether orally and in writing
p.000004: informed of all aspects of the examination that are relevant to the decision to participate. The consent of the respondents is
p.000004: documents using the signed statement of consent of the interviewee with the date of signature;
p.000004: ii) Randomization is the process of engaging subjects in therapy or control groups using random methods
p.000004: election to reduce bias;
p.000004: jj) Standard Operating Procedures (SOPs) are detailed written instructions for implementing each specific situation throughout
p.000004: clinical trials, which allow all functions and activities to be performed equally during a particular clinical trial
p.000004: testing;
p.000004: kk) Certificate of Good Clinical Practice - document confirming knowledge of Good Clinical Practice;
p.000004: ll) Raw data are or certified copies of original observations, clinical findings and other activity data
p.000004: within the clinical trial required for reconstruction and evaluation of the trial. The information provided
p.000004: also include laboratory records, notes, accounts, data obtained through automated instruments, accurate
p.000004: verified copies in the form of photocopies, photographic negatives, microfilms or magnetic media;
p.000004: mm) An Examiner Instruction is a document containing relevant drug information, analytical information,
p.000004: pharmacological-toxicological testing, as well as clinical trials to date of the medicinal product concerned, including
p.000004: data that is relevant to
p.000004: clinical trial to which they refer. The guidance also includes information that justifies the nature, scope and duration
p.000004: tests, potential harm assessment, special warnings and are updated in accordance with new data.
p.000004: Article 3
p.000004: (Phases of clinical trial of the drug)
p.000004: The clinical trial of the drug is divided into several phases as follows:
p.000004: a) Phase 1: Represents an examination of the first administration of the drug to humans and is conducted to establish a preliminary assessment
p.000004: the safety and pharmacokinetic / pharmacodynamic profile of the active substance in humans;
p.000004: b) Phase 2: This implies Phase 2a and Phase 2b;
p.000004: Phase 2a of the clinical trial represents an early phase of drug administration in a small number of selected subjects who
p.000004: expect beneficial side effects of did medicine. It is carried out with the aim of ascertaining the efficacy and safety of did medication as well
p.000004: dose range.
p.000004: Phase 2b of the clinical trial represents a late phase of drug administration in a large number of selected subjects, with a goal
p.000004: making the final decision on dosage range and pharmaceutical form. During this phase of the clinical trial, i
p.000004: collecting data on metabolic activities in the human body over the long term
p.000004: period versus phase 2a;
p.000004: c) Phase 3: Represents the administration of the drug to a sufficiently large number of selected subjects for determination
p.000004: efficacy and safety of administration of the test drug.
p.000004: A sufficiently large number of subjects means the number of subjects from the accepted professional examination protocol
p.000004: an institution conducting clinical trials for this stage to evaluate the result;
p.000004: d) Phase 4: Represents the release of the medicinal product in limited quantities under supervision. It is conducted for the purpose of monitoring
p.000004: the impact of the drug under conditions of limited marketing in selected professional clinical trial institutions
p.000004: medicines;
p.000004: e) Post-marketing phase: represents drug testing, ie monitoring and collecting additional data on
p.000004: its efficacy and safety, after obtaining a marketing authorization.
p.000004: PART TWO - CLINICAL TESTING OF MEDICINES
p.000004: CHAPTER I - CLINICAL TESTING PROCEDURE
p.000004: Article 4
p.000004: (Content and method of clinical trial of the drug)
p.000004: (1) The clinical trial shall determine: the efficacy of the drug, the relationship between the beneficial and adverse effects of the drug,
p.000004: side effects, bioequivalence and bioavailability;
p.000004: (2) All clinical trials of medicinal products on humans must be conducted in accordance with the ethical principles laid down in Helsinki
p.000004: the Patient Rights Protection Declaration (hereinafter: the Declaration of Helsinki) and in accordance with the rules of good clinical
p.000004: practices and this Rulebook;
p.000004: (3) The medicinal product may be clinically tested after having received a positive evaluation of the pharmaceutical-chemical-biological and pharmacological-
p.000004: toxicological study of the drug.
p.000004: Article 5
p.000004: (Investigator)
p.000004: (1) Clinical trials shall be performed at the request of the client of the trial: the manufacturer, that is, legal or natural persons
p.000004: which acts on behalf of the manufacturer and is established in Bosnia and Herzegovina, interested legal persons, individuals, or at
p.000004: the request of the competent ministry;
p.000004: (2) The test client is responsible for the reliability of the data and information made available to the examiner
p.000004: before the start of the clinical trial, or those that occur during the trial;
p.000004: (3) The investigator and the examiner are obliged to cooperate with the authorized institution where the clinical
p.000004: testing regarding reporting, implementation of changes to clinical trial protocols, reporting adverse events, and
p.000004: submission of test reports;
p.000004: (4) The contracting authority shall organize a quality assurance system (including independent supervision) for implementation
p.000004: testing;
p.000004: (5) The contracting authority shall prepare written detailed standard operating procedures (SOPs), in accordance with Good
p.000004: clinical practice;
p.000004: (6) The investigator and the examiner must agree and sign the clinical trial protocol, and
p.000004: determine the method of data entry.
p.000004: Article 6
p.000004: (Authorization for clinical trial of a medicinal product)
p.000004: (1) Each clinical trial of a medicinal product must be approved by the Agency for Medicinal Products and Medical Devices of Bosnia
p.000004: and Herzegovina (hereinafter: the Agency);
p.000004: (2) Prior to granting a license to conduct a clinical trial of a medicinal product "referred to in paragraph (2) of this Article"
p.000004: obtain the approval of the Clinical Trials Committee for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: (the Commission);
p.000004: (3) The Agency is obliged to issue a clinical trial authorization within 60 days from the date of admission
p.000004: a formal request, based on the Commission's opinion.
p.000004: Article 7
p.000004: (Costs of clinical trial of the drug)
p.000004: (1) The costs of applying for a clinical trial and licensing shall be borne by the applicant for the trial;
p.000004: (2) The amount of compensation for the work of the members of the Commission shall be determined by a decision of the Agency and shall be borne by the proposer
p.000004: testing.
p.000004: Article 8
p.000004: (Contents of request for clinical trial of drug)
p.000004: The following shall be attached to the application for authorization to conduct a clinical trial of a medicinal product and a medical device
p.000004: documentation:
p.000004: a) a cover letter with a mandatory list of documents with the date and signature of the applicant;
p.000004: b) the completed clinical trial authorization form for the medicinal product or medical device which is in Annex (I) of this
p.000004: Of the Rules and forms an integral part thereof;
p.000004: c) information on the sponsor of the study;
p.000004: d) a contractual research organization (CRO) authorization letter;
p.000004: logo, name and address of the examiner (logo if any); the name of the professional institution that will participate in the
p.000004: examination, including the approval of the Ethics Committee (s) of the professional institution certifying participation in the
p.000004: the present clinical trial;
p.000004: e) the name of the clinical trial;
p.000004: f) the name of the medicinal product to be tested;
p.000004: g) pharmaceutical form and strength;
p.000004: h) "ATC" - classification, if any;
p.000004: i) the name of the manufacturer;
p.000004: j) proof of payment of the costs of the proceedings;
p.000004: k) a statement of the purpose of the study, the indication of the test phase and the registration status of the medicinal product;
p.000004: l) summary of the clinical study protocol in the local language;
p.000004: m) the clinical trial plan (protocol) with the date and signature of the principal investigator for that clinical trial;
p.000004: n) booklet for the researcher in the local language;
p.000004: o) evidence of the subject's insurance against the potential adverse consequences of participating in the clinical trial; and
p.000004: a medical device that must cover the complete clinical trial period - local insurance (in which case
p.000004: there are data on the number of centers and the number of respondents);
p.000004: p) current knowledge of adverse effects;
p.000004: q) a form for reporting serious adverse drug reactions;
p.000004: r) a list of countries where a clinical trial is being conducted, including Bosnia and Herzegovina, if multicenter;
p.000004: s) a list of countries where the study drug is registered;
p.000004: t) the CRP Case Report Form test lists;
p.000004: u) notification for the respondent in the local language;
p.000004: v) Respondent's consent form with the place of signature of the patient and the principal investigator and the place for the date at
p.000004: local language;
p.000004: w) card of the patient participating in the study;
p.000004: x) "CV" of the researcher;
p.000004: y) evidence of education in the field of good clinical practice for the principal investigator.
p.000004: Article 9
p.000004: (Appointment of Principal Investigator and Clinical Trial Investigator)
p.000004: (1) The principal investigator for clinical trials shall appoint a medical doctor or
p.000004: of dentist.
p.000004: (2) The principal investigator may be assigned to a maximum of three clinical studies during one calendar year.
p.000004: Article 10
p.000004: (Contents of the documentation for the drug under study)
p.000004: The documentation for the drug under study contains:
p.000004: a) a certificate of good manufacturing practice;
p.000004: b) Certificate of completed drug analysis;
p.000004: c) drug labeling;
p.000004: d) evidence of completed pharmacochemical tests with a positive evaluation;
p.000004: e) evidence of a positive pharmacological-toxicological study;
p.000004: f) evidence of the registration status of the medicinal product in the manufacturer's country;
p.000004: g) summary of product characteristics and package leaflet.
p.000004: Article 11
p.000004: (Contents of clinical trial protocol)
p.000004: (1) The clinical trial protocol shall contain: general information; random selection and "blind" testing and statistical
p.000004: analysis.
p.000004: a) general information includes the name of the clinical trial, identification number and date. Accessories must have their own
p.000004: number and date. The general information contains the name and address of the examiner and the competent observer, the names of the persons who will
p.000004: sign the clinical trial protocol and annexes on behalf of the trial sponsor and examiner responsible for
p.000004: conducting the trial, and the name of the institution where the trial is being conducted. The clinical trial protocol should
p.000004: contain the objective of the test, the measures that will be taken to avoid bias, and in particular, where appropriate
p.000004: important, and the methods of & quot; blind & quot; examinations and selection of respondents;
p.000004: b) the manner of random selection of respondents must be documented. When the examiner receives a closed code for each
p.000004: individual therapy, in a "blind" randomized trial, it should be archived, both at the test site and
p.000004: with the test proponent. In the case of a blinded trial, the clinical trial protocol must include the conditions under
p.000004: who are allowed to open the code and name of the person authorized to do so. It is necessary to provide a system, which will
...
p.000004: the contracting authority and the examiner.
p.000004: (3) The contracting authority and the examiner must agree on any change that occurs during the examination,
p.000004: sign it and add it in addition to the clinical trial protocol (amendment).
p.000004: (4) The clinical trial protocol must describe the objectives of the trial, the procedures to be followed,
p.000004: the reasons why the test is conducted on humans, the nature and degree of any known risk, the groups from which they will
p.000004: Respondents are also selected ways to ensure adequate information before respondent agrees
p.000004: participates in the examination.
p.000004: (5) The model of the protocol for conducting the clinical trial has the prescribed content in Annex number (II) and its constituent
p.000004: is part of this Ordinance.
p.000004: Article 12
p.000004: (Contents of Instructions for Examiner)
p.000004: (1) The Examiner Instruction is a brief overview of existing clinical and pre-clinical trial data on a
p.000004: examines in a clinical trial.
p.000004: (2) The proponent of the study must regularly obtain new knowledge of the medicinal product obtained during the clinical trial
p.000004: provide the examiner with supplemental instructions.
p.000004: (3) The examiner's instruction shall contain:
p.000004: a) the content of the clinical trial,
p.000004: b) the content of the clinical trial,
p.000004: c) introductory remarks,
p.000004: d) the physical, chemical and pharmaceutical properties of the pharmaceutical formulation and formulation,
p.000004: e) preclinical studies (preclinical pharmacology, pharmacokinetics and drug metabolism in animals; and
p.000004: toxicology);
p.000004: f) the effect of the test drug in humans (Pharmacokinetics, drug metabolism in humans, tolerability, effects,
p.000004: traffic data),
p.000004: g) summary of product characteristics and conclusion.
p.000004: (4) At the end of each section of the instruction, the examiner must provide a list of the literature used in the clinical trial
p.000004: drug, and the most important literature should be provided in full.
p.000004: Article 13
p.000004: (Competence of the Commission)
p.000004: Upon receipt of the request and documentation for the clinical trial, the Commission shall review the request and evaluate:
p.000004: a) eligibility of the examiner for the proposed examination;
p.000004: b) the appropriateness of the clinical trial protocol with regard to the objectives of the trial and the justification of the foreseeable hazards; and
p.000004: risks in relation to the assumed benefit to respondents and other persons;
p.000004: c) the manner of inclusion of the subjects in the clinical trial;
p.000004: d) the comprehensibility and completeness of the information provided to the respondents;
p.000004: e) insurance and reimbursement in case of death, that is, treatment of clinical subjects
p.000004: by examining;
p.000004: f) eligibility of additions to the clinical trial protocol.
p.000004: Article 14
p.000004: (Respondents' voluntary consent principles - Declaration of Helsinki)
p.000004: The principles of voluntary consent of the subjects must be applied in each clinical trial, in accordance with the provisions
p.000004: The Declaration of Helsinki, and in particular:
p.000004: a) the respondent is provided with information about the clinical trial in oral and written form;
p.000004: b) no compulsion to participate in the clinical trial is allowed;
p.000004: c) the respondents, their loved ones, guardians and legal representatives must be allowed to acquire
p.000004: knowledge of test details;
p.000004: d) the information "referred to in paragraph (3) of this Article" must contain a clear message that it is an examination, that participation
...
p.000004: participation in the examination protected as professional secrecy and as such made available to the public;
p.000004: g) the candidate must be informed about the insurance and treatment procedures for treatment in case of damage or
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
p.000004: to a specific group of patients, and that such research is essential for the evaluation of clinical data
p.000004: by questioning individuals who are capable of giving their written consent;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: Opinions of a specialist in pediatrics, with particular reference to clinical, ethical and psychosocial
p.000004: problems in conducting a clinical trial of a drug.
p.000004: (4) During the conduct of a clinical trial of a drug, an able-bodied juvenile shall form an opinion and evaluate it
p.000004: The information he has received about participating in a clinical trial may make the decision to take any
p.000004: at the time of withdrawal or withdrawal from the clinical trial of the drug, which shall be reported to the principal investigator or member
p.000004: research team.
p.000004: (5) The applicant / client is in the process of approving a clinical trial of a medicinal product intended for children
p.000004: obliged to submit to the Commission the positive opinion of the Entity Ministries of Health / Health and the Department of Health
p.000004: Brcko District.
p.000004: Article 16
p.000004: (Specific requirements for clinical trial of an adult drug)
p.000004: (1) Clinical trial of a drug by an adult respondent who is unable to obtain legally valid informed consent
p.000004: (unconsciousness, limited physical or mental capacity, etc.), ie on adult respondent who did not refuse
p.000004: consent to participate in a clinical trial of a drug prior to the onset of its incapacity shall be subject to conditions
p.000004: prescribed by law and this regulation.
p.000004: (2) In addition to the conditions "referred to in paragraph (1) of this Article", a clinical trial of a medicinal product may also be conducted if:
p.000004: a) legal representative of an adult respondent who is unable to give legally valid informed consent in writing
p.000004: consent. The written consent of the sea represents the presumed desire of the respondent and can be withdrawn at any
p.000004: moment, without harm to him;
p.000004: b) an adult candidate who is unable to give written consent has received information to the best of his or her ability
p.000004: to understand, by a person who has experience in working with such persons, relating to the course of the clinical
p.000004: examinations, risk and health benefits of respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: what material or other uses;
p.000004: d) it is estimated that a clinical trial of the medicinal product on that face provides direct benefit to a group of patients whose
p.000004: illness or condition corresponds to illness or condition of the subjects;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: the opinion of a specialist doctor for a particular area or condition of the subjects, or for the population of patients to whom
p.000004: clinical trial of the drug relates, with particular reference to clinical, ethical and psycho-social problems in implementation
p.000004: clinical trial of the drug.
p.000004: (3) During the conduct of the clinical trial of a medicinal product, an adult who is unable to provide an informed written person
p.000004: consent, which is able to form an opinion and evaluate the information it has received about participating in the clinical
p.000004: drug test, can be withdrawn at any time, or waived the clinical drug test, of which
p.000004: informs the principal investigator or member of the research team.
p.000004: Article 17
p.000004: (Respondent's health care)
p.000004: The respondent must be provided with adequate health care for the duration of the examination. Health care
p.000004: must also be ensured after examination in a period that depends on the nature of the disease, the manner of testing and the tests done
p.000004: interventions.
p.000004: Article 18
p.000004: (Clinical trial site and staff)
p.000004: (1) The clinical trial shall be conducted under conditions that guarantee the safety of the subjects.
p.000004: (2) The choice of clinical trial site depends on the degree of product development and the associated potential risks.
p.000004: (3) In the case of clinical trials aimed at entering the genome of subjects for exercise
p.000004: pharmacogenomic and pharmacogenetic knowledge, the same can only be carried out if the required samples and data are provided
p.000004: anonymity or anonymity.
p.000004: (4) The clinical trial site must have adequate personnel, facilities and equipment, including laboratories.
p.000004: (5) In the composition of the research team in the clinical trial of the medicinal product being carried out in the healthcare institution providing it
p.000004: secondary or tertiary health care must be included by a medical doctor-specialist in clinical
p.000004: pharmacology, when the first phase of clinical trial of the drug is being conducted.
p.000004: (6) In certain parts of the clinical trial of the medicinal product, in addition to the medical doctor and the doctor of dentistry,
p.000004: these include professionals with other relevant education (pharmacists, specialists)
p.000004: medical biochemists or clinical biochemists, statisticians, nurses, health technicians, and
p.000004: Dr.).
p.000004: Article 19
p.000004: (Multicenter drug test)
p.000004: (1) In the case of a multicenter trial, the study of the drug shall be carried out simultaneously with several examiners, at
p.000004: different sites, based on the same clinical trial protocol.
p.000004: (2) Multicenter testing "referred to in paragraph (1) of this Article" requires a special administrative system whose form depends
p.000004: of the number of study sites, test endpoints, and available information on the drug being tested.
p.000004: (3) The multicenter examination protocol shall describe the functions, responsibilities, rights and obligations of all
p.000004: participants in the clinical trial procedure.
p.000004: (4) In the case of multicenter examination, it is permissible to establish a coordinating committee or coordinator s
p.000004: responsibility for overseeing the practical conduct and progress of testing and maintaining contacts with the Agency, a professional
p.000004: the institution where the clinical trial is being conducted, as well as other competent authorities in this field.
p.000004: Article 20
p.000004: (Notification of clinical trial)
p.000004: The test proponent should regularly inform the Agency and the authorized institution where the flow test is being conducted
p.000004: and the results of the trial, at the conclusion of each phase of the clinical trial.
p.000004: Article 21
p.000004: (Suspension and prohibition of clinical trial of the drug)
p.000004: (1) While conducting a clinical trial, the Agency may suspend or suspend a clinical trial at
p.000004: in the following cases:
p.000004: a) if it finds that the conditions laid down in the law, in this regulation or in the application for a permit have not been fulfilled,
p.000004: that is, a license to conduct a clinical trial of the drug
p.000004: b) if required by the safety of the subjects or the protection of health;
p.000004: c) if the principal investigator, sub-investigators or any other person involved in the approved clinical trials does not
p.000004: meet regulatory obligations and are not governed by good clinical practice;
p.000004: d) upon the final and enforcement decision of the pharmaceutical inspector.
p.000004: (2) The Agency shall issue a decision on the suspension or prohibition of further clinical trials
p.000004: the opinion of the Commission obtained. The decision "referred to in paragraph (2) of this Article" is finally in administrative procedure.
p.000004: Article 22
p.000004: (Explanation of early completion of clinical trial and final report)
p.000004: (1) If the clinical trial of the drug is completed before the expiration of the time specified in the clinical trial protocol,
p.000004: the examiner must provide a justification for the early completion of the examination to the Agency and the professional institution where it is performed
p.000004: clinical trial.
p.000004: (2) Upon completion of the examination, a final report shall be prepared. The report "referred to in paragraph (2) of this Article", as correct
p.000004: the indicated end date of the clinical trial must be signed by the lead examiner and submitted to the Agency and the professional
p.000004: the institution where the clinical trial is being conducted.
p.000004: Article 23
p.000004: (Contents of final report)
p.000004: (1) The final report on the clinical trial of the medicinal product shall contain:
p.000004: a) general information,
p.000004: b) the protocol, phases and standard operating procedures for conducting the technical trial according to Good Clinical Practice;
p.000004: c) test results including:
p.000004: 1. clinical pharmacology (pharmacodynamics, pharmacokinetics, interactions),
p.000004: 2. bioavailability / bioequivalence,
p.000004: 3. clinical efficacy and safety,
p.000004: 4. information on the use of the medicine in countries where it is authorized.
p.000004: (2) The contents of the form for the final report on the implementation of the clinical trial of the medicinal product are laid down in Annex No. IV and
p.000004: It shall form an integral part of this Regulation.
p.000004: CHAPTER II - OBLIGATIONS OF PARTICIPANTS IN THE CLINICAL TESTING OF MEDICINES AND DOCUMENTATION
p.000004: Article 24
p.000004: (Obligations of test proponent)
p.000004: The test proponent is obliged to:
p.000004: a) make the choice of examiner taking into account the location of the examination, the equipment and the credibility of the qualifications
p.000004: the examiner and the duration of the examination;
p.000004: b) inform the examiner of the chemical, pharmaceutical, toxicological, pharmacological and clinical information on the medicinal product
p.000004: (including previous and concurrent tests) in accordance with the nature, scope and duration of the tests as a prerequisite for
p.000004: test planning, and provide the examiner with all relevant new information and drug information that emerges during
p.000004: testing;
p.000004: c) submit a request with all the necessary documents to the professional institution where the clinical trial of the medicinal product is performed;
p.000004: d) to provide and deliver appropriately labeled and appropriately coded medicines for testing prepared in accordance with
p.000004: principles of Good Manufacturing Practice and properly packaged in such a way as to protect the product from damage, provided that it is
p.000004: process blindness ensured;
p.000004: e) keep sufficient samples of each batch and data on the analysis and characteristics of the product under test
p.000004: so that they can be re-examined if necessary by an independent laboratory;
p.000004: f) provide the examiner with the opportunity to establish in his institution a system for proper and safe handling,
p.000004: storage, privacy, return and destruction of the investigational medicinal product, and appoints a responsible person to perform these
p.000004: affairs;
p.000004: g) determine and provide training for the competent observer;
p.000004: h) designate persons to supervise the process and to verify the statistical processing and write the test report;
p.000004: i) to consider with the examiner without delay all side effects and take appropriate safety measures
p.000004: to submit the report of adverse reaction to the Agency;
p.000004: j) ensure that a full final test report is prepared;
p.000004: k) provide adequate compensation for the treatment or treatment for the subjects in case of damage or death
p.000004: related to the examination except for those resulting from malpractice or negligence.
p.000004: Article 25
p.000004: (Special obligations of test proponent)
p.000004: (1) In addition to the obligations "referred to in Article 24 of this Ordinance", the testing proponent shall be obliged to secure the supply of the medicinal product for
p.000004: test (test product or reference product, including placebo) so that they are appropriate
p.000004: quality and undergo quality assurance procedures.
p.000004: (2) The manner in which the test proponent supplies the examiner with the drugs under examination shall be
p.000004: described in the clinical trial protocol.
p.000004: (3) The proposer of the test shall supply the examiner with the drug when he has obtained the necessary clinical trial permit from
p.000004: Import Agencies and Consents by the Entity Ministries of Health.
p.000004: (4) The proponent of the test shall, when delivering the medicines "referred to in paragraph (3) of this Article," submit it to the examiner
p.000004: and written instructions on how to handle and store these medicines, as well as instructions on how to handle what they will after the test
p.000004: possibly remaining unused.
p.000004: (5) The proponent of the examination shall be obliged to draw up the delivery of medicines as well as the written instructions "from paragraph (4) of this Article"
p.000004: a written statement.
p.000004: (6) The test proponent must ensure the stability of the investigational medicinal product as well as its regular supply
p.000004: throughout the examination.
p.000004: (7) The proponent of the test shall be obliged to describe in detail the manner in which the investigational medicinal product will be labeled,
p.000004: deliver, distribute and store.
p.000004: (8) The notes must contain information on the transport, shipment, receipt, distribution, return and destruction of each
p.000004: of the remaining drug. The examiner must not administer the medication being tested to any person not designated to receive it.
p.000004: (9) The test proponent shall be responsible for the proper packaging and labeling of the investigational medicinal products. The mark must
p.000004: indicate that the product is for clinical trial use only.
p.000004: (10) In blind tests, the packaging must be labeled in such a way as to prevent identification. U
p.000004: emergency situations must be able to determine the identity of current treatment received by a particular respondent.
p.000004: (11) In blind studies, the drug to be tested, including the control drug and placebo, must be of equal value.
p.000004: appearance, taste, smell and other physical characteristics.
p.000004: (12) It is the responsibility of the test proponent to ensure that the packaging of the investigational medicinal product is of appropriate dimensions for
p.000004: testing and appropriate for the respondents and is required to provide sufficient samples of each batch used for the sake of
p.000004: needs for re-analysis and control in the future.
p.000004: (13) Should the formulation of the control drug change, the need for comparative in vivo biological consideration should be considered
p.000004: tests and test dissolution or other in vitro tests.
p.000004: Article 26
p.000004: (Clinical Trial Observer)
p.000004: (1) The competent observer shall be determined by the contracting authority with the consent of the examiner. The number of competent observers depends on
p.000004: the complexity of drug testing and the number of participating centers. The competent observer must be available to the examiner.
p.000004: (2) The primary obligation of the competent observer is to supervise the conduct of the test and to ensure that it is conducted in accordance with that
p.000004: test protocol.
p.000004: (3) Any unjustified deviation from the test protocol and any violation of Good Clinical Practice by a competent observer
p.000004: must, without delay, inform the investigator, the Agency and the professional institution where the clinical is performed
p.000004: examination.
p.000004: Article 27
p.000004: (Special Obligations of Clinical Trial Observer)
p.000004: (1) In addition to the basic obligation "referred to in Article 26 of this Ordinance", the competent observer shall also have the obligation:
p.000004: a) supervise the implementation of the test protocol and ensure that all test data is kept orderly and complete
p.000004: recorded;
p.000004: b) determine whether adequate space, personnel and equipment, laboratories,
p.000004: and assess the availability of an adequate number of subjects during the examination;
p.000004: c) ensure that staff assisting the examiner in the examination are informed of the examination and that all details are respected
p.000004: testing;
p.000004: d) ensure liaison between the examiner and the proposer of the test during the conduct of the test;
p.000004: e) ensure that the test lists of respondents are filled in correctly;
p.000004: f) examine whether the supplies, distribution and refund of the investigational medicinal product have been secured and documented at
p.000004: appropriate manner in accordance with regulations;
p.000004: g) submit a written report to the examiner after each visit and every other contact with the examiner.
p.000004: (2) During the visit to the examiner, the competent observer must check:
p.000004: a) whether the test drug is used solely for the purposes specified in the clinical trial protocol;
p.000004: b) that there is information on the quantities of the drug being tested;
p.000004: b.
p.000004: c) storage conditions of the investigational medicinal product;
p.000004: d) treatment with returned or unused drug.
p.000004: Article 28
p.000004: (Side effects, side effects and adverse events during clinical trial of the drug)
p.000004: (1) The occurrence of any undesirable effect, adverse reaction or adverse event of a did drug must be taken carefully
p.000004: monitor and record in detail throughout the examination.
p.000004: (2) The clinical trial protocol shall specify the method by which adverse reactions, adverse reactions or
p.000004: adverse events "referred to in paragraph (1) of this Article".
p.000004: (3) The investigator shall make available to the Agency questionnaires for reporting adverse reactions.
p.000004: (4) The client must report all adverse reactions to the Agency and the ethical committee of the institution where the clinical is performed.
p.000004: examination.
p.000004: (5) The reports "referred to in paragraph (4) of this Article” must contain evaluations of causation and possible impact on the
p.000004: examination and future use of the product being tested, as well as the identification of the subjects and methods of testing.
p.000004: (6) Upon completion of the study, any recorded adverse reactions of did drug or medical devices must be determined
p.000004: and evaluated in the final report.
p.000004: (7) The contracting authority shall, without delay, inform the examiner of any trial of the same medicinal product, anywhere
p.000004: and discontinued at any time, as well as withdrawal of that medicine for lack of safety.
p.000004: Article 29
p.000004: (Notes and information during the clinical trial of the medicine)
p.000004: (1) The purpose of keeping notes in the drug test procedure is to register information, transfer information,
p.000004: effective and proper modification of information obtained from respondents into data that can be used in the report.Svi
p.000004: test procedures must be documented.
p.000004: (2) The basic feature of the uniqueness of the data is to ensure a "blind" test with respect to species determination
p.000004: treatment, which begins with the randomization of subjects into different groups and is maintained throughout the data processing
p.000004: until the decision to open the code is made.
p.000004: (3) In the case of electronic data processing, the confidentiality of the database must be specifically ensured as well as its accuracy.
p.000004: Article 30
p.000004: (Method and time limit for keeping clinical trial records)
p.000004: (1) The contracting authority shall ensure that the respondents' identification codes are archived for security reasons and
p.000004: efficiency.
p.000004: (2) The contracting authority shall take appropriate measures to keep the other documentation relating to
p.000004: examination.
p.000004: (3) The information "referred to in paragraph (2) of this Article" may be stored on a microfilm or electronically, provided that there is a copy on
p.000004: paper.
p.000004: (4) The trial contracting authority must keep the clinical trial protocol, documentation, permit and all other documents
p.000004: concerning the tests, including certificates on how to perform the procedures 5 years after the end of the clinical trials,
p.000004: that is, even after the said deadline, if other applicable criteria or agreements between the contracting authorities so require
p.000004: examiners and examiners.
p.000004: Article 31
p.000004: (Examiner's obligations)
p.000004: (1) The examiner shall be responsible for strictly implementing the clinical trial protocol as follows:
p.000004: a) The examiner may not make any changes to the approved test except in the case of a direct procedure if necessary
p.000004: to eliminate the obvious imminent risk or danger to the respondents by obligatory notifying the Agency thereof;
p.000004: b) in the case of annexes to the clinical trial protocol, the prior approval of the Commission shall be obtained;
p.000004: c) the form of the annexes to the protocol related to the conduct of the clinical trial of the medicinal product has the prescribed contents in Annex no.
p.000004: (III) and is an integral part of this Regulation;
p.000004: d) the examiner must provide appropriate information to the subjects in the clinical trial and comply with the provisions
p.000004: The Declaration of Helsinki and the International Ethical Guidelines for Human Biomedical Testing;
p.000004: e) The nature of the information to be communicated to the subjects depends on the complexity of the clinical trial and the type of drug
p.000004: being examined;
p.000004: f) the information "referred to in point e) of this paragraph" shall, as a rule, be given both verbally and in writing and in a language which is
p.000004: understandable to the respondent;
p.000004: g) the examiner is obliged to inform the subjects about their participation in the clinical trial, to mark the persons from whom
p.000004: may request assistance in an emergency, and alert to the need to keep the said information with them;
p.000004: h) the examiner must be aware of the properties and effects, including information obtained prior to the clinical trial, o
p.000004: the product being tested clinically;
p.000004: i) the examiner must be aware of all relevant new product information that appears during the clinical course
p.000004: testing;
p.000004: j) in the case of a serious undesirable effect, the examiner must inform the proposer of the test without delay,
p.000004: the professional institution where the clinical trial is conducted and through the applicant the Agency;
p.000004: k) the examiner must be available at periodic visits by the competent observer and during the supervision
p.000004: the pharmaceutical inspector as well as the persons designated by the test proponent for quality assurance.
p.000004: (2) The examiner must ensure that:
p.000004: a) safe treatment with the medicinal product being tested during and after the test;
p.000004: b) that the investigational medicinal product is used only in accordance with the clinical trial protocol and is being tested
p.000004: include respondents who are responsible to the examiner;
p.000004: c) the dose and instructions for use are appropriate and understood by each subject;
p.000004: d) that the unused drug under test be returned or destroyed and the notes made on it
p.000004: keep activities according to the test protocol.
p.000004: Article 32
p.000004: (Obligations of the contracting authority)
p.000004: (1) The contracting authority shall be responsible for the implementation of the quality assurance system with regard to site verification
p.000004: the conduct of the examination, all data and records relating thereto.
p.000004: (2) All observations and findings must be available for verification to ensure the credibility of all information, and that
p.000004: the conclusions drawn from the processing of the raw data obtained are correct.
p.000004: (3) Verification procedures must be justified and specified.
p.000004: (4) Sampling should be controlled by a statistically acceptable method of verification in testing.
p.000004: (5) Quality control must be applied at every stage of data processing, to ensure that all data
p.000004: be safe and properly handled.
p.000004: PART THREE - CLINICAL TESTING OF MEDICAL AGENT
p.000004: Article 33
p.000004: (Purpose of clinical trial of medical device)
p.000004: Testing of a medical device is performed to determine or confirm its effectiveness, safety and quality, in agreement
p.000004: declared use specified by the manufacturer.
p.000004: Article 34
p.000004: (Medical drug classes and clinical trial)
p.000004: (1) A clinical trial of a medical device is the determination or confirmation of the safety of a medical device,
p.000004: its effectiveness and compliance with the general and specific requirements as specified by the manufacturer.
p.000004: (2) A clinical trial shall be conducted for a Class IIa, IIb and Class III medical device, until a Class I medical device,
p.000004: except for a medical device that is sterile or that contains a radiation source.
p.000004: (3) For the clinical trial "referred to in paragraph (2) of this Article", the license shall be issued by the Agency.
p.000004: (4) The clinical trial procedure of a medical device must correspond to current scientific and technical achievements
p.000004: and principles of good clinical practice in clinical trial and medical ethics. Clinical trial results must
p.000004: capture the results of all available clinical trials of the medical device, whether positive or negative.
p.000004: (5) The documentation of the clinical trial of a medical device must include the test results that are
p.000004: detailed and objectively described and available to enable an objective assessment of the benefit-risk relationship for the patient
p.000004: an assessment of its safety, efficacy and an opinion on whether the medical device is general and specific
p.000004: the requirements of the Act and the purpose specified by the manufacturer.
p.000004: Article 35
p.000004: (Contents of clinical trial requirements for medical devices)
p.000004: (1) The following must be attached to the application for authorization to conduct a clinical trial of a medical device
p.000004: the documentation referred to in Annex number (V) which forms an integral part of this Regulation:
...
p.000004: based on it.
p.000004: (6) If it is proved that the safety, efficacy and compliance of the medical device with the general and specific requirements do not
p.000004: in accordance with the provisions of the Act and the regulations adopted thereunder, the costs of the clinical trial shall be borne by the manufacturer
p.000004: that is, the importer of the medical device.
p.000004: Article 39
p.000004: (Changes, final report and notification of clinical trial of medical device)
p.000004: (1) The manufacturer shall submit to the Agency any amendments or modifications to an already approved medical test plan
p.000004: funds.
p.000004: (2) The report signed by the principal investigator must contain a critical appraisal of all information obtained and collected
p.000004: during the clinical trial of the medical device.
p.000004: (3) The applicant for the clinical trial request shall notify the competent authorities of the Member States concerned of
p.000004: the completion of the clinical trial of the medical device, and in the event of early termination, the notification must be followed
p.000004: by reasoning.
p.000004: PART FOUR - TRANSITIONAL AND FINAL PROVISIONS
p.000004: Article 40
p.000004: (Amendments to the Rules)
p.000004: Amendments to this Ordinance shall be made in the manner and by the procedure for its adoption.
p.000004: Article 41
p.000004: (Termination of regulations)
p.000004: With the entry into force of this Rulebook, the Rulebook on Good Clinical Practice and Clinical Trials
p.000004: ("Official Gazette of the Federation of Bosnia and Herzegovina", No. 61/04), Rulebook on Amendments to the Rulebook on Good Clinical Practice
p.000004: and clinical trials of the medicinal product (Official Gazette of the Federation of Bosnia and Herzegovina, No. 56/05), Rulebook on Clinical
p.000004: drug testing ("Official Gazette of the Republika Srpska", no. 64/05) and Rulebook on Amendments to the Rulebook on
p.000004: clinical trial of the medicinal product (Official Gazette of the Republika Srpska, No. 23/07).
p.000004: Article 42
p.000004: (Entry into Force and Publication)
p.000004: This Rulebook shall enter into force on the day of its adoption and shall be published in the Official Gazette of BiH.
p.000004: No. 08-02-2-1172-2-JD / 09
p.000004: December 10, 2009
p.000004: Minister
p.000004: Mr. Sredoje Novic, s. r.
p.000004: Annex (1)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Medicines Agency of Bosnia and Herzegovina
p.000004: APPLICATION FOR A CLINICAL TESTING AUTHORIZATION / CLINICAL TEST APPLICATION
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: test proponent Test drug, name, form (s) of drug, strength (s)
p.000004: contract research organization
p.000004: examiner
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: yes License number:
p.000004: no
p.000004: Marketing Authorization Holder (name, address):
p.000004: The approval procedure in Bosnia and Herzegovina is ongoing: yes
p.000004: Number of requests: no
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: licensing: no
p.000004: Country, year and approval number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration: Dosage in clinical trial: Active substance (s), name
p.000004: (for radiopharmaceuticals - radionuclide):
p.000004: Substance contained in a drug already registered in the world: no
p.000004: yes Countries where it is registered and year of registration:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: the drug in question contains more active substances: yes
p.000004: Type of medicine:
p.000004: no Specify total number:
p.000004: Radiopharmaceutical drug
p.000004: Drug containing synthetic active substance Herbal drug
p.000004: A drug for dental use
p.000004: A drug containing a narcotic or psychotropic substance
p.000004: Other medicines intended for use in testing
p.000004: Name of the drug, form (s), strength (s):
p.000004: Immunological Drug Blood Derivative Biotechnological Drug Others Specify:
p.000004: Yes no
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: no yes License number:
p.000004: Holder of Marketing Authorization (name, address):
p.000004: The procedure for issuing a license in BiH is to:
p.000004: no
p.000004: Number of requests:
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: The medicine is registered in another country:
p.000004: Expiration date:
p.000004: Method of administration:
p.000004: yes Study number and date
p.000004: no license:
p.000004: yes Earth, year and number
p.000004: do not allow: Storage conditions:
p.000004: Dosage in clinical trial:
p.000004: Active substance (s), name (for radiopharmaceuticals - radionuclide)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Clinical trial protocol Documentation of the investigational medicinal product
p.000004: no no
p.000004: no
p.000004: Part / Side: from-to
p.000004: Researcher brochure / summary of product characteristics
p.000004: Sample Test List
p.000004: Ethics Committee (s) approval Statement of the Professional Collegium / Institution Director
p.000004: GMP certificate
p.000004: Biography of Principal Investigator Proof of Paid Compensation
p.000004: Other documents
p.000004: Number of pages added by the applicant due to lack of space on the form:
p.000004: I declare that the information in the request and the supporting documentation is true and that no important fact that may affect
p.000004: the safety of the participants in the examination and the credibility of the conclusions are not hidden.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
p.000004: Appendix to Annex (I)
p.000004: Guidance for Applicants for Clinical Trial Authorization / Application for a Clinical Trial
p.000004: The application for a clinical trial license shall be submitted for each clinical trial of the unlicensed medicinal product
p.000004: for the marketing of the medicinal product in Bosnia and Herzegovina (clinical trial: Phase I - III and bioequivalence testing);
p.000004: the application for a clinical trial shall be submitted in the case of a medicinal product authorized to be placed on the market
p.000004: traffic in Bosnia and Herzegovina, when the drug is used in accordance with the marketing authorization
p.000004: traffic in Bosnia and Herzegovina, e.g. in accordance with the approved summary of product characteristics. Form
p.000004: to apply must be typed on a typewriter or computer. In the event that in any
p.000004: part of the form does not have enough space for data, additional pages are used, which become an integral part of the form with
p.000004: note that there is an add-on for the part in question. Documentation references are not recommended.
p.000004: 1) List all drug forms and all potencies of the investigational medicinal product to be used in the clinical setting
p.000004: in Bosnia and Herzegovina. Strength indicates the amount of active substance per unit of individual
p.000004: dosage, per unit volume or per unit mass and this is indicated if the drug contains one active
p.000004: substance. In case the active substance is in the form of salts, hydrates, etc. it must be clarified whether
p.000004: strength refers to the whole molecule of the substance or only its active part.
p.000004: 2) Indicate if the medicinal product has a marketing authorization in Bosnia and Herzegovina.
p.000004: 3) If there are multiple forms or strengths of the medicinal product used in the clinical trial, provide information for
p.000004: each shape and strength.
p.000004: 4) In the case of medicinal products not authorized for marketing in Bosnia and Herzegovina, state the proposed deadline
p.000004: of use.
p.000004: 5) In the case where there are several forms of medicine or more ways of administration of the drug, provide all the necessary information.
p.000004: 6) Where the active substance is in the form of salts, hydrates, etc., it must be clearly stated whether the amount
p.000004: refers to the whole molecule of the substance or only its active part.
p.000004: 7) If the medicinal product contains more than one active substance, list all active substances on the additional page with all information as well as
p.000004: for the first active substance.
p.000004: 8) Narcotics and Psychotropic Substances are the substances listed in the Narcotics Production and Trafficking Act
p.000004: establishing a list of narcotic drugs.
p.000004: 9) List the medicines to be used in the trial in Bosnia and Herzegovina and which are explicitly stated in the plan
p.000004: (protocol) testing, e.g. comparative drugs or drugs specifically suggested for basic or auxiliary use
p.000004: treatment. If more than one medication is available, an additional side is used, which becomes an integral part of the claim.
p.000004: 10) List all drug forms and all strengths of the drug to be used in the trial in Bosnia and
p.000004: Herzegovina.
p.000004: 11) If the test cannot be classified into just one of the stages, indicate that it has multiple options or
p.000004: list them.
p.000004: 12) Tests are classified in Phase IV if the drug has been used in accordance with an approved summary of the main
p.000004: characteristics of the drug. Tests exploring new indications, new modes of administration, new fixed ones
p.000004: combinations, trials with much higher doses than previously approved and trials that are
p.000004: funnels on patient groups not previously approved are not considered for phase IV trials.
p.000004: 13) Multiple types of testing can be characterized.
p.000004: 14) In the case of large-scale trials, indicate approximately the number of respondents.
p.000004: 15) List all the institutions where the examination is being conducted in Bosnia and Herzegovina. In case of space shortage, state this
p.000004: on the additional page that becomes an integral part of the request.
p.000004: 16) In the case of multiple examiners, indicate the lead examiner responsible for conducting the test.
p.000004: 17) The laboratory testing facility is considered to be part of the facility where it is conducted
p.000004: examination of the drug in case it is within the same health institution and is at the same address
p.000004: perform all biochemical and haematological tests, and determine plasma drug levels or drug concentrations in urine,
p.000004: feces, etc.
p.000004: 18) Indicate if the same clinical trial, or trial of the same drug or the same active substance was approved.
p.000004: 19) Mark those parts of the documentation that are submitted with the application.
p.000004: 20) In accordance with the Clinical Trial Regulations, the applicant is required to reimburse all costs of the evaluation
p.000004: clinical trial permit applications or clinical trial application costs at
p.000004: filing a claim. The amount to be paid and the payment procedure will subsequently be determined and invoiced
p.000004: to the applicant.
p.000004: Annex (II)
p.000004: MODEL OF THE CLINICAL TESTING PROTOCOL
p.000004: The clinical trial plan (protocol) must include the following:
p.000004: 1. Name and justification for conducting the test;
p.000004: 2. The meaning, purpose and purpose of the examination;
p.000004: 3. Venue of the test, name and address of the test client;
p.000004: 4. Name, address and qualifications of each examiner;
p.000004: 5. Description of the type of test;
p.000004: 6. Ethical side examination and measures to ensure ethical aspects (interviewee consent);
p.000004: 7. Description of the respondents. Criteria for inclusion and non-inclusion of potential respondents and how they are collected,
p.000004: types, methods and time of assignment of respondents. Exclusion criteria for previously included respondents;
p.000004: 8. Number of respondents required to achieve the objective of the examination based on statistical considerations;
p.000004: 9. Description and justification of the route of administration, the dose, the interval between doses and the period of administration of the investigational medicinal product and that
p.000004: used as a control;
p.000004: 10. Any other treatment that may or may be used at the same time as the treatment
p.000004: testing;
p.000004: 11. Clinical and laboratory tests during the course of pharmacokinetic analysis and others which are approved during the study
p.000004: plan (protocol) tests must be carried out;
p.000004: 12. Description of how the reactions to the administration of the drug will be recorded. Description and evaluation of measurement methods, measurement time, method
p.000004: monitoring;
p.000004: 13. Instructions for completing the whole or part of the test;
p.000004: 14. Methods of registering and reporting adverse events, adverse reactions and adverse events. Procedure
p.000004: in case of complications;
p.000004: 15. Method of archiving the list of subjects with the codes of the subjects, data on the use of the drug, the list of randomization and / or the test list.
p.000004: The records must allow for easy identification of individual respondents or participants as well as surveillance data and
p.000004: reconstruction (data);
p.000004: 16. Information on the test code of where it will be archived and when, how and by whom in case of emergency
p.000004: open;
p.000004: 17. Measures to be taken to ensure the safe handling and storage of pharmaceutical products and measures to ensure
p.000004: encourage and control adherence to all clinical trial guidelines;
p.000004: 18. Description of methodology and evaluation of results (eg statistical methods) as well as description of patients / participants who have dropped out
p.000004: testing
p.000004: 19. Time until completion of examination;
p.000004: 20. Information to be provided to the respondents including information on how they will be notified of the examination and how and where
p.000004: will give consent;
p.000004: 21. Instructions for persons, e.g. how the persons will be informed of the manner in which the examination will be conducted and its application;
p.000004: 22. Definition of medical care for the subjects after the examination including the method of treatment;
p.000004: 23. Data on financing, insurance, liability and transfer / distribution of responsibilities;
p.000004: 24. List of references referred to in the test plan.
p.000004: Annex (III)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
...
p.000004: CLINICAL TEST COMPLETION NOTICE
p.000004: Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the proponent of the examination to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: proponent of the examination
p.000004: Completion of examination
p.000004: contract research organization
p.000004: examiner
p.000004: Completion of examination in Bosnia and Herzegovina yes no Date:. . .year.
p.000004: Completion of testing in all countries where the test was conducted
p.000004: yes
p.000004: no Date:. . .year.
p.000004: Premature examination completed yes
p.000004: Suspension yes
p.000004: Reason for provisionally ending the test:
p.000004: Security yes
p.000004: Inefficiency yes
p.000004: Testing not started yes
p.000004: Second yes
p.000004: no Date:. . .year.
p.000004: no Date:. . .year.
p.000004: no no no no
p.000004: Specify:
p.000004: Number of subjects still receiving therapy at the time of discontinuation or suspension of a clinical trial at
p.000004: Bosnia and Herzegovina
p.000004: In case of interruption of the clinical trial or its early termination, briefly describe in the Appendix:
p.000004: - justification for termination or early termination of the examination
p.000004: - the proposed treatment of subjects receiving therapy at the time of early termination or suspension
p.000004: - the consequences of prematurely discontinuing the trial to evaluate the results and analyze the benefit-risk balance of the test drug
p.000004: I declare that the information given in the notice is correct and that clinical trial reports will be submitted
p.000004: The Agency and the responsible ethics committee within 90 days of the completion of the examination in all countries in which it was conducted
p.000004: examination.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
p.000004: Annex (V)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: APPLICATION FOR A CLINICAL TESTING OF A MEDICAL MEDICINE / APPLICATION OF A CLINICAL TEST
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Investigator (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: Investigator
p.000004: contract research organization
p.000004: examiner
p.000004: Tested medical device, name, form (s) of medical device, packaging (s)
...
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p.000004: ll) Raw data are or certified copies of original observations, clinical findings and other activity data
p.000004: within the clinical trial required for reconstruction and evaluation of the trial. The information provided
p.000004: also include laboratory records, notes, accounts, data obtained through automated instruments, accurate
p.000004: verified copies in the form of photocopies, photographic negatives, microfilms or magnetic media;
p.000004: mm) An Examiner Instruction is a document containing relevant drug information, analytical information,
p.000004: pharmacological-toxicological testing, as well as clinical trials to date of the medicinal product concerned, including
p.000004: data that is relevant to
p.000004: clinical trial to which they refer. The guidance also includes information that justifies the nature, scope and duration
p.000004: tests, potential harm assessment, special warnings and are updated in accordance with new data.
p.000004: Article 3
p.000004: (Phases of clinical trial of the drug)
p.000004: The clinical trial of the drug is divided into several phases as follows:
p.000004: a) Phase 1: Represents an examination of the first administration of the drug to humans and is conducted to establish a preliminary assessment
p.000004: the safety and pharmacokinetic / pharmacodynamic profile of the active substance in humans;
p.000004: b) Phase 2: This implies Phase 2a and Phase 2b;
p.000004: Phase 2a of the clinical trial represents an early phase of drug administration in a small number of selected subjects who
p.000004: expect beneficial side effects of did medicine. It is carried out with the aim of ascertaining the efficacy and safety of did medication as well
p.000004: dose range.
p.000004: Phase 2b of the clinical trial represents a late phase of drug administration in a large number of selected subjects, with a goal
p.000004: making the final decision on dosage range and pharmaceutical form. During this phase of the clinical trial, i
p.000004: collecting data on metabolic activities in the human body over the long term
p.000004: period versus phase 2a;
p.000004: c) Phase 3: Represents the administration of the drug to a sufficiently large number of selected subjects for determination
p.000004: efficacy and safety of administration of the test drug.
p.000004: A sufficiently large number of subjects means the number of subjects from the accepted professional examination protocol
p.000004: an institution conducting clinical trials for this stage to evaluate the result;
p.000004: d) Phase 4: Represents the release of the medicinal product in limited quantities under supervision. It is conducted for the purpose of monitoring
...
p.000004: APPLICATION FOR A CLINICAL TESTING AUTHORIZATION / CLINICAL TEST APPLICATION
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: test proponent Test drug, name, form (s) of drug, strength (s)
p.000004: contract research organization
p.000004: examiner
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: yes License number:
p.000004: no
p.000004: Marketing Authorization Holder (name, address):
p.000004: The approval procedure in Bosnia and Herzegovina is ongoing: yes
p.000004: Number of requests: no
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: licensing: no
p.000004: Country, year and approval number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration: Dosage in clinical trial: Active substance (s), name
p.000004: (for radiopharmaceuticals - radionuclide):
p.000004: Substance contained in a drug already registered in the world: no
p.000004: yes Countries where it is registered and year of registration:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: the drug in question contains more active substances: yes
p.000004: Type of medicine:
p.000004: no Specify total number:
p.000004: Radiopharmaceutical drug
p.000004: Drug containing synthetic active substance Herbal drug
p.000004: A drug for dental use
p.000004: A drug containing a narcotic or psychotropic substance
p.000004: Other medicines intended for use in testing
p.000004: Name of the drug, form (s), strength (s):
p.000004: Immunological Drug Blood Derivative Biotechnological Drug Others Specify:
p.000004: Yes no
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: no yes License number:
p.000004: Holder of Marketing Authorization (name, address):
p.000004: The procedure for issuing a license in BiH is to:
p.000004: no
p.000004: Number of requests:
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: The medicine is registered in another country:
p.000004: Expiration date:
p.000004: Method of administration:
p.000004: yes Study number and date
p.000004: no license:
p.000004: yes Earth, year and number
p.000004: do not allow: Storage conditions:
p.000004: Dosage in clinical trial:
p.000004: Active substance (s), name (for radiopharmaceuticals - radionuclide)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Clinical trial protocol Documentation of the investigational medicinal product
p.000004: no no
p.000004: no
p.000004: Part / Side: from-to
p.000004: Researcher brochure / summary of product characteristics
p.000004: Sample Test List
p.000004: Ethics Committee (s) approval Statement of the Professional Collegium / Institution Director
p.000004: GMP certificate
p.000004: Biography of Principal Investigator Proof of Paid Compensation
p.000004: Other documents
p.000004: Number of pages added by the applicant due to lack of space on the form:
p.000004: I declare that the information in the request and the supporting documentation is true and that no important fact that may affect
p.000004: the safety of the participants in the examination and the credibility of the conclusions are not hidden.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
p.000004: Appendix to Annex (I)
p.000004: Guidance for Applicants for Clinical Trial Authorization / Application for a Clinical Trial
p.000004: The application for a clinical trial license shall be submitted for each clinical trial of the unlicensed medicinal product
p.000004: for the marketing of the medicinal product in Bosnia and Herzegovina (clinical trial: Phase I - III and bioequivalence testing);
p.000004: the application for a clinical trial shall be submitted in the case of a medicinal product authorized to be placed on the market
p.000004: traffic in Bosnia and Herzegovina, when the drug is used in accordance with the marketing authorization
p.000004: traffic in Bosnia and Herzegovina, e.g. in accordance with the approved summary of product characteristics. Form
p.000004: to apply must be typed on a typewriter or computer. In the event that in any
p.000004: part of the form does not have enough space for data, additional pages are used, which become an integral part of the form with
p.000004: note that there is an add-on for the part in question. Documentation references are not recommended.
p.000004: 1) List all drug forms and all potencies of the investigational medicinal product to be used in the clinical setting
p.000004: in Bosnia and Herzegovina. Strength indicates the amount of active substance per unit of individual
p.000004: dosage, per unit volume or per unit mass and this is indicated if the drug contains one active
p.000004: substance. In case the active substance is in the form of salts, hydrates, etc. it must be clarified whether
p.000004: strength refers to the whole molecule of the substance or only its active part.
p.000004: 2) Indicate if the medicinal product has a marketing authorization in Bosnia and Herzegovina.
p.000004: 3) If there are multiple forms or strengths of the medicinal product used in the clinical trial, provide information for
p.000004: each shape and strength.
p.000004: 4) In the case of medicinal products not authorized for marketing in Bosnia and Herzegovina, state the proposed deadline
p.000004: of use.
p.000004: 5) In the case where there are several forms of medicine or more ways of administration of the drug, provide all the necessary information.
p.000004: 6) Where the active substance is in the form of salts, hydrates, etc., it must be clearly stated whether the amount
p.000004: refers to the whole molecule of the substance or only its active part.
p.000004: 7) If the medicinal product contains more than one active substance, list all active substances on the additional page with all information as well as
p.000004: for the first active substance.
p.000004: 8) Narcotics and Psychotropic Substances are the substances listed in the Narcotics Production and Trafficking Act
p.000004: establishing a list of narcotic drugs.
p.000004: 9) List the medicines to be used in the trial in Bosnia and Herzegovina and which are explicitly stated in the plan
p.000004: (protocol) testing, e.g. comparative drugs or drugs specifically suggested for basic or auxiliary use
p.000004: treatment. If more than one medication is available, an additional side is used, which becomes an integral part of the claim.
p.000004: 10) List all drug forms and all strengths of the drug to be used in the trial in Bosnia and
p.000004: Herzegovina.
p.000004: 11) If the test cannot be classified into just one of the stages, indicate that it has multiple options or
p.000004: list them.
p.000004: 12) Tests are classified in Phase IV if the drug has been used in accordance with an approved summary of the main
p.000004: characteristics of the drug. Tests exploring new indications, new modes of administration, new fixed ones
p.000004: combinations, trials with much higher doses than previously approved and trials that are
p.000004: funnels on patient groups not previously approved are not considered for phase IV trials.
p.000004: 13) Multiple types of testing can be characterized.
p.000004: 14) In the case of large-scale trials, indicate approximately the number of respondents.
p.000004: 15) List all the institutions where the examination is being conducted in Bosnia and Herzegovina. In case of space shortage, state this
p.000004: on the additional page that becomes an integral part of the request.
p.000004: 16) In the case of multiple examiners, indicate the lead examiner responsible for conducting the test.
p.000004: 17) The laboratory testing facility is considered to be part of the facility where it is conducted
p.000004: examination of the drug in case it is within the same health institution and is at the same address
p.000004: perform all biochemical and haematological tests, and determine plasma drug levels or drug concentrations in urine,
p.000004: feces, etc.
p.000004: 18) Indicate if the same clinical trial, or trial of the same drug or the same active substance was approved.
p.000004: 19) Mark those parts of the documentation that are submitted with the application.
p.000004: 20) In accordance with the Clinical Trial Regulations, the applicant is required to reimburse all costs of the evaluation
p.000004: clinical trial permit applications or clinical trial application costs at
p.000004: filing a claim. The amount to be paid and the payment procedure will subsequently be determined and invoiced
p.000004: to the applicant.
p.000004: Annex (II)
p.000004: MODEL OF THE CLINICAL TESTING PROTOCOL
p.000004: The clinical trial plan (protocol) must include the following:
p.000004: 1. Name and justification for conducting the test;
p.000004: 2. The meaning, purpose and purpose of the examination;
p.000004: 3. Venue of the test, name and address of the test client;
p.000004: 4. Name, address and qualifications of each examiner;
p.000004: 5. Description of the type of test;
p.000004: 6. Ethical side examination and measures to ensure ethical aspects (interviewee consent);
p.000004: 7. Description of the respondents. Criteria for inclusion and non-inclusion of potential respondents and how they are collected,
p.000004: types, methods and time of assignment of respondents. Exclusion criteria for previously included respondents;
p.000004: 8. Number of respondents required to achieve the objective of the examination based on statistical considerations;
p.000004: 9. Description and justification of the route of administration, the dose, the interval between doses and the period of administration of the investigational medicinal product and that
p.000004: used as a control;
p.000004: 10. Any other treatment that may or may be used at the same time as the treatment
p.000004: testing;
p.000004: 11. Clinical and laboratory tests during the course of pharmacokinetic analysis and others which are approved during the study
...
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: APPLICATION FOR A CLINICAL TESTING OF A MEDICAL MEDICINE / APPLICATION OF A CLINICAL TEST
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Investigator (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: Investigator
p.000004: contract research organization
p.000004: examiner
p.000004: Tested medical device, name, form (s) of medical device, packaging (s)
p.000004: Manufacturer of medical device (name, address):
p.000004: Medical device registered in BiH: yes Certificate number:
p.000004: no
p.000004: Holder of certificate for registration of the register of medical devices (name, address):
p.000004: The procedure for certification in Bosnia and Herzegovina is underway:
p.000004: yes Number of requests: no
p.000004: The medical device has been tested in BiH:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: yes licensing: no
p.000004: Country, year and certificate number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration of medical device:
p.000004: Active substance (s), name (for medicinal products containing the medicinal product or medicinal substances):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: Countries where the medical device is registered and year of registration:
p.000004: no yes
p.000004: the medicinal product being tested contains more active substances:
p.000004: Type of medical device:
p.000004: Class I Class IIa Class IIb Class III
p.000004: In vitro diagnostic medical devices
p.000004: Medical Information:
p.000004: Name, type, model:
p.000004: Label, size, packaging:
p.000004: Proposal for the labeling of the medical device and instructions for use:
p.000004: Clinical trial plan:
p.000004: Yes no
p.000004: Specify the total number:
p.000004: Main objective of the test:
p.000004: Methods:
p.000004: Control system:
p.000004: Organization and method of statistical processing:
p.000004: Other goals:
p.000004: Types of testing:
p.000004: Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Respondents: Healthy volunteers Number of patients: Total number of respondents:
p.000004: Patients Total number of examinees in BiH
p.000004: One center testing
p.000004: In several centers in BiH
p.000004: International multicenter in countries:
p.000004: Length of administration of the tested medical device:
p.000004: Specify the monitoring period:
p.000004: Estimated test duration:
p.000004: Criteria for patient involvement: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including zip code):
p.000004: Name of researcher:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
...
Health / Healthy People
Searching for indicator healthyXvolunteers:
(return to top)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
...
p.000004: Medical device registered in BiH: yes Certificate number:
p.000004: no
p.000004: Holder of certificate for registration of the register of medical devices (name, address):
p.000004: The procedure for certification in Bosnia and Herzegovina is underway:
p.000004: yes Number of requests: no
p.000004: The medical device has been tested in BiH:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: yes licensing: no
p.000004: Country, year and certificate number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration of medical device:
p.000004: Active substance (s), name (for medicinal products containing the medicinal product or medicinal substances):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: Countries where the medical device is registered and year of registration:
p.000004: no yes
p.000004: the medicinal product being tested contains more active substances:
p.000004: Type of medical device:
p.000004: Class I Class IIa Class IIb Class III
p.000004: In vitro diagnostic medical devices
p.000004: Medical Information:
p.000004: Name, type, model:
p.000004: Label, size, packaging:
p.000004: Proposal for the labeling of the medical device and instructions for use:
p.000004: Clinical trial plan:
p.000004: Yes no
p.000004: Specify the total number:
p.000004: Main objective of the test:
p.000004: Methods:
p.000004: Control system:
p.000004: Organization and method of statistical processing:
p.000004: Other goals:
p.000004: Types of testing:
p.000004: Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Respondents: Healthy volunteers Number of patients: Total number of respondents:
p.000004: Patients Total number of examinees in BiH
p.000004: One center testing
p.000004: In several centers in BiH
p.000004: International multicenter in countries:
p.000004: Length of administration of the tested medical device:
p.000004: Specify the monitoring period:
p.000004: Estimated test duration:
p.000004: Criteria for patient involvement: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including zip code):
p.000004: Name of researcher:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The examination is related to obtaining a certificate for entry in the medical registry
p.000004: funds in BiH:
p.000004: Yes no
p.000004: Clinical trial already approved in other countries: yes no Earth,
p.000004: license number, date of issue:
p.000004: ,,
p.000004: Certificate of Compliance with General and Specific Requirements
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Positive opinion of the Commission for Clinical Trials of BiH
p.000004: Proof of insurance in the event of damage to the person or persons under examination
p.000004: Respondent Information Form and Written Consent
p.000004: yes
p.000004: Proof of paid compensation
p.000004: Excerpt from medical device test plan
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000004: y) An unexpected side effect of a drug is one that has an unknown nature, severity or outcome,
p.000004: that is, they are not described in the Summary of Product Characteristics and Package Leaflet, or are not part of this effect
p.000004: current knowledge of the drug;
p.000004: z) Adverse event in clinical trial is an unwanted experience (any adverse and undesirable sign such as
p.000004: abnormal laboratory result, symptoms, or disease in the trial) that occurred during the clinical
p.000004: drug testing, whether or not it has a causal relationship to drug use;
p.000004: aa) Other respondent documentation includes hospital records, specialist examination findings and / or
p.000004: special information about the respondent that allows to determine the authenticity of the information in the test lists of respondents and
p.000004: if necessary, allow them to be supplemented and corrected;
p.000004: bb) Clinical trial quality assurance includes the quality assurance systems and procedures in place
p.000004: conducting trials and obtaining data in accordance with Good Clinical Practice, including rules on ethical and
p.000004: professional implementation of standard operating procedures, reporting and qualification of professional staff;
p.000004: cc) A serious adverse reaction in a clinical trial is an undesirable and unintentionally induced reaction to
p.000004: drug in a clinical trial that results in death, imminent life-threatening, disability,
p.000004: hospital treatment (which was not previously required), an extension of hospital treatment or congenital anomaly,
p.000004: that is, birth defects and after birth;
p.000004: dd) A serious adverse event in a clinical trial is an adverse experience that occurred during the clinical trial
p.000004: drug testing, whether or not it has a causal connection with the use of the drug, resulting in death
p.000004: life-threatening, disability, hospital treatment (if not required before), hospital extension
p.000004: treatment, congenital anomalies, or defect at and after birth, or malignancy during the test;
p.000004: ee) Post-marketing intervention clinical trial is a prospective trial in which the drug is administered
p.000004: apply in accordance with the conditions specified in the marketing authorization, which requires additional
p.000004: diagnostic procedures as well as monitoring procedures defined by the clinical trial protocol;
p.000004: ff) Post-marketing non-interventional clinical trial (pharmacoepidemiological study) is a trial
p.000004: in which the drug is administered in accordance with the conditions set out in the marketing authorization of the choice
p.000004: Patients are not predetermined by the clinical trial protocol but fall into current established practice
p.000004: The prescribing is clearly separate from the decision to enroll the patient in the trial. Extra
p.000004: diagnostic or monitoring procedures are not applied and the results obtained are analyzed epidemiologically
p.000004: methods;
p.000004: gg) Test protocol is a document containing the objective, plan and methodology of the test, the method of statistical processing
p.000004: clinical trial data and organization, in accordance with Good Clinical Practice;
p.000004: hh) Respondent's consent is the written statement of the respondent, parent of a minor child, guardian or legal representative,
p.000004: by which he voluntarily confirms his willingness to participate in a particular clinical trial, whether orally and in writing
...
p.000004: to request a permit for clinical trial of a medical device to make a decision with the justified reasons why
p.000004: the request is denied. The decision is finally in administrative procedure and no appeal is allowed, but it can be initiated
p.000004: administrative dispute before a competent court.
p.000004: (3) The time limit referred to in "paragraph (2) of this Article" shall expire on the day on which the Agency submits the applicant for clinical trial
p.000004: request the necessary additional information or explanations and the interruption of the deadline will continue until the request of the Agency is fulfilled.
p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
p.000004: (4) Agency or Entity Ministries of Health or Department of Health of the Brcko District, other state or
p.000004: the entity ministry or other legal entity may require a clinical trial of the medical device for use
p.000004: protection of population health.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000004: b) no compulsion to participate in the clinical trial is allowed;
p.000004: c) the respondents, their loved ones, guardians and legal representatives must be allowed to acquire
p.000004: knowledge of test details;
p.000004: d) the information "referred to in paragraph (3) of this Article" must contain a clear message that it is an examination, that participation
p.000004: in the clinical trial is voluntary and that refusal to participate, that is, refusal to participate in the trial
p.000004: freely;
p.000004: e) respondents must have sufficient time to decide whether or not they wish to participate in the examination;
p.000004: f) the subjects must be aware and agree to check the test results and be aware that it is
p.000004: participation in the examination protected as professional secrecy and as such made available to the public;
p.000004: g) the candidate must be informed about the insurance and treatment procedures for treatment in case of damage or
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
...
p.000004: to request a permit for clinical trial of a medical device to make a decision with the justified reasons why
p.000004: the request is denied. The decision is finally in administrative procedure and no appeal is allowed, but it can be initiated
p.000004: administrative dispute before a competent court.
p.000004: (3) The time limit referred to in "paragraph (2) of this Article" shall expire on the day on which the Agency submits the applicant for clinical trial
p.000004: request the necessary additional information or explanations and the interruption of the deadline will continue until the request of the Agency is fulfilled.
p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
p.000004: (4) Agency or Entity Ministries of Health or Department of Health of the Brcko District, other state or
p.000004: the entity ministry or other legal entity may require a clinical trial of the medical device for use
p.000004: protection of population health.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000004: consent to participate in a clinical trial of a drug prior to the onset of its incapacity shall be subject to conditions
p.000004: prescribed by law and this regulation.
p.000004: (2) In addition to the conditions "referred to in paragraph (1) of this Article", a clinical trial of a medicinal product may also be conducted if:
p.000004: a) legal representative of an adult respondent who is unable to give legally valid informed consent in writing
p.000004: consent. The written consent of the sea represents the presumed desire of the respondent and can be withdrawn at any
p.000004: moment, without harm to him;
p.000004: b) an adult candidate who is unable to give written consent has received information to the best of his or her ability
p.000004: to understand, by a person who has experience in working with such persons, relating to the course of the clinical
p.000004: examinations, risk and health benefits of respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: what material or other uses;
p.000004: d) it is estimated that a clinical trial of the medicinal product on that face provides direct benefit to a group of patients whose
p.000004: illness or condition corresponds to illness or condition of the subjects;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: the opinion of a specialist doctor for a particular area or condition of the subjects, or for the population of patients to whom
p.000004: clinical trial of the drug relates, with particular reference to clinical, ethical and psycho-social problems in implementation
p.000004: clinical trial of the drug.
p.000004: (3) During the conduct of the clinical trial of a medicinal product, an adult who is unable to provide an informed written person
p.000004: consent, which is able to form an opinion and evaluate the information it has received about participating in the clinical
p.000004: drug test, can be withdrawn at any time, or waived the clinical drug test, of which
p.000004: informs the principal investigator or member of the research team.
p.000004: Article 17
p.000004: (Respondent's health care)
p.000004: The respondent must be provided with adequate health care for the duration of the examination. Health care
p.000004: must also be ensured after examination in a period that depends on the nature of the disease, the manner of testing and the tests done
p.000004: interventions.
p.000004: Article 18
p.000004: (Clinical trial site and staff)
...
Health / Unconscious People
Searching for indicator not conscious:
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p.000004: (2) If the clinical trial is refused, the Agency shall be obliged not later than 30 days from the receipt of the complete
p.000004: to request a permit for clinical trial of a medical device to make a decision with the justified reasons why
p.000004: the request is denied. The decision is finally in administrative procedure and no appeal is allowed, but it can be initiated
p.000004: administrative dispute before a competent court.
p.000004: (3) The time limit referred to in "paragraph (2) of this Article" shall expire on the day on which the Agency submits the applicant for clinical trial
p.000004: request the necessary additional information or explanations and the interruption of the deadline will continue until the request of the Agency is fulfilled.
p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
p.000004: (4) Agency or Entity Ministries of Health or Department of Health of the Brcko District, other state or
p.000004: the entity ministry or other legal entity may require a clinical trial of the medical device for use
...
Health / ill
Searching for indicator ill:
(return to top)
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
...
p.000004: 1. In treating a patient, the physician must be able to use new diagnostic and therapeutic measures, if any
p.000004: in his view, they offer hope for saving lives, restoring health and reducing suffering.
p.000004: 2. The potential benefits, dangers and inconveniences of the new method must be weighed against the benefits
p.000004: the best standard diagnostic and therapeutic methods.
p.000004: 3. In each clinical study, each patient, including one in the control group, should have, if available,
p.000004: the best, most proven diagnostic and therapeutic method available. That, in cases where there is no proven
p.000004: diagnostic or therapeutic methods, does not exclude the use of placebo.
p.000004: 4. A patient's refusal to participate in the examination should never affect his or her relationship with the physician.
p.000004: 5. If the doctor deems it necessary not to obtain consent, the specific reasons for this must be stated in the plan
p.000004: (protocol) tests, to be submitted to an independent representative.
p.000004: 6. The physician may combine medical examination with professional supervision in order to acquire new medical knowledge
p.000004: only to the extent that the test is justified in terms of its potential diagnostic or therapeutic
p.000004: values for the patient.
p.000004: III Non-therapeutic biomedical testing in humans (non-clinical biomedical testing)
p.000004: 1. In the purely scientific application of medical examination to humans, it is the duty of the physician to remain a protector
p.000004: the life and health of the person to be tested.
p.000004: 2. The subject must be a volunteer, healthy or ill, for whom the type of examination is not related to his or her own
p.000004: disease.
p.000004: 3. The examiner or examination team must suspend the tests if it concludes that further testing may be detrimental
p.000004: to the respondent.
p.000004: 4. In human inquiry, the interest of science and society can never be more important than the welfare of the respondents.
p.000004: 2004 Audits
p.000004: Every patient who has entered the study has the right to be treated by the best method and upon leaving the study.
p.000004: Testing of each new procedure should be compared according to the best existing method, where it exists, not
...
Social / Access to Social Goods
Searching for indicator access:
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p.000004: the respondent, the examiner, or the competent observer do not know what anyone has received.
p.000004: n) Data coding categories
p.000004: Single-coded data and samples are marked with one specific code and do not imply any personal information
p.000004: identifiers. In the case of single coding, data or samples can be linked to a specific person
p.000004: using the encryption key. The clinical investigator is responsible for keeping the coding key. Since the samples and
p.000004: supporting information can be indirectly linked to the research subject, using a coding key, can be taken
p.000004: procedures such as drawing a sample or returning individual results at the request of the subject. Single use
p.000004: coded data and samples allows clinical monitoring, monitoring of the subject or supplementing of the subject's data.
p.000004: Single coding is currently the standard used in clinical research and offers an additional guarantee of
p.000004: subject identifiers, in relation to the general principles of trust in the health care system and privacy protection in
p.000004: daily medical practice;
p.000004: Duplicate encoded data and samples were originally marked with one specific code and did not carry any personal data
p.000004: information.
p.000004: The data and samples are then labeled with a second code that is first linked via the second encryption key. Data or
p.000004: patterns can be linked to the face using both encryption keys. The clinical researcher is responsible for safeguarding the former
p.000004: encryption key and has no access to another key. As samples and corresponding data can be very indirectly linked to
p.000004: subject to the use of both coding keys, procedures such as sample withdrawal or retrieval may be undertaken
p.000004: individual results at the request of the subject.
p.000004: However, additional electronic or technical processes may limit the ability to associate the genotype result with
p.000004: face. E.g. a certain computer procedure may add new data to the subject, but connection is prevented
p.000004: genotype data with the subject's personal information. The use of duplicate encoded data and samples is made possible clinically
p.000004: monitoring, monitoring the subject or supplementing the data.
p.000004: The use of the second code provides additional confidence and protection of the privacy of the entities, greater than that of the single code
p.000004: encoding. Access to both keys is required to merge any data or patterns with the subject's personal information.
p.000004: The anonymized data and samples were originally single or double coded, but there is a link between personal data
p.000004: subjects and unique codes are then deleted. Once a connection has been deleted, it is no longer possible to associate data and samples with
p.000004: to people via encryption keys. "Anonymization" prevents the subject from being re-identified. Since being "anonymized"
p.000004: samples and relevant data cannot relate to the subject. It is not possible to undertake procedures such as sample withdrawal
p.000004: or the return of individual results even at the request of the subject. The use of anonymized data and samples does not allow
p.000004: clinical monitoring, monitoring the subject or adding new data. By deleting the encryption keys that bind the data
p.000004: and specimens with personal information about the subject are provided with additional confidence and privacy protection as this is prevented
p.000004: reidentification of the subject using keys. Anonymous data and samples are never marked with personal information when
p.000004: they collect, nor does the coding key be generated.
p.000004: Therefore, there is no possibility of linking genomic data and samples with individual subjects. In some cases only
p.000004: limited clinical information may be associated with anonymous samples (e.g., samples from diabetic subjects, men,
p.000004: age 50-55 g., cholesterol> mg / dl). Because anonymous samples and relevant data cannot be associated with subjects,
p.000004: it is not possible to undertake procedures such as sample withdrawal, return of individual results, even at the request of the subject.
...
p.000004: f) evidence of the registration status of the medicinal product in the manufacturer's country;
p.000004: g) summary of product characteristics and package leaflet.
p.000004: Article 11
p.000004: (Contents of clinical trial protocol)
p.000004: (1) The clinical trial protocol shall contain: general information; random selection and "blind" testing and statistical
p.000004: analysis.
p.000004: a) general information includes the name of the clinical trial, identification number and date. Accessories must have their own
p.000004: number and date. The general information contains the name and address of the examiner and the competent observer, the names of the persons who will
p.000004: sign the clinical trial protocol and annexes on behalf of the trial sponsor and examiner responsible for
p.000004: conducting the trial, and the name of the institution where the trial is being conducted. The clinical trial protocol should
p.000004: contain the objective of the test, the measures that will be taken to avoid bias, and in particular, where appropriate
p.000004: important, and the methods of & quot; blind & quot; examinations and selection of respondents;
p.000004: b) the manner of random selection of respondents must be documented. When the examiner receives a closed code for each
p.000004: individual therapy, in a "blind" randomized trial, it should be archived, both at the test site and
p.000004: with the test proponent. In the case of a blinded trial, the clinical trial protocol must include the conditions under
p.000004: who are allowed to open the code and name of the person authorized to do so. It is necessary to provide a system, which will
p.000004: in case of urgency, provide access to information about the treatment of the individual respondent. The system must allow access
p.000004: treatment of only one subject at a time. If the code is open, the same should be justified and documented in
p.000004: test lists of respondents;
p.000004: c) the types of statistical analysis must be specified in the clinical trial protocol and any deviation from
p.000004: the clinical trial protocol must be described and justified in the final trial report. Planned Analysis i
p.000004: its implementation must be carried out or confirmed and identified by an educated statistician. Options or
p.000004: the circumstances of the inter-assay during the trial must also be specified in the clinical trial protocol.
p.000004: The examiner and the authorized observer must ensure that the data is of the highest quality possible at the stage of their own
p.000004: collection, and the statistician must ensure uniformity of data during processing. The results of the analyzes must be presented
p.000004: in such a way that they allow the interpretation of clinical relevance by assessing the magnitude of the difference in treatment effect and interval
p.000004: reliability is more than just testing for statistical significance. An estimate of the data omitted from
p.000004: statistical analysis. All such exclusions must be documented so that they can be repeated if necessary
p.000004: analysis.
p.000004: (2) The clinical trial should be conducted in accordance with the clinical trial protocol agreed and signed by
p.000004: the contracting authority and the examiner.
p.000004: (3) The contracting authority and the examiner must agree on any change that occurs during the examination,
p.000004: sign it and add it in addition to the clinical trial protocol (amendment).
p.000004: (4) The clinical trial protocol must describe the objectives of the trial, the procedures to be followed,
...
Searching for indicator access to information:
(return to top)
p.000004: d) evidence of completed pharmacochemical tests with a positive evaluation;
p.000004: e) evidence of a positive pharmacological-toxicological study;
p.000004: f) evidence of the registration status of the medicinal product in the manufacturer's country;
p.000004: g) summary of product characteristics and package leaflet.
p.000004: Article 11
p.000004: (Contents of clinical trial protocol)
p.000004: (1) The clinical trial protocol shall contain: general information; random selection and "blind" testing and statistical
p.000004: analysis.
p.000004: a) general information includes the name of the clinical trial, identification number and date. Accessories must have their own
p.000004: number and date. The general information contains the name and address of the examiner and the competent observer, the names of the persons who will
p.000004: sign the clinical trial protocol and annexes on behalf of the trial sponsor and examiner responsible for
p.000004: conducting the trial, and the name of the institution where the trial is being conducted. The clinical trial protocol should
p.000004: contain the objective of the test, the measures that will be taken to avoid bias, and in particular, where appropriate
p.000004: important, and the methods of & quot; blind & quot; examinations and selection of respondents;
p.000004: b) the manner of random selection of respondents must be documented. When the examiner receives a closed code for each
p.000004: individual therapy, in a "blind" randomized trial, it should be archived, both at the test site and
p.000004: with the test proponent. In the case of a blinded trial, the clinical trial protocol must include the conditions under
p.000004: who are allowed to open the code and name of the person authorized to do so. It is necessary to provide a system, which will
p.000004: in case of urgency, provide access to information about the treatment of the individual respondent. The system must allow access
p.000004: treatment of only one subject at a time. If the code is open, the same should be justified and documented in
p.000004: test lists of respondents;
p.000004: c) the types of statistical analysis must be specified in the clinical trial protocol and any deviation from
p.000004: the clinical trial protocol must be described and justified in the final trial report. Planned Analysis i
p.000004: its implementation must be carried out or confirmed and identified by an educated statistician. Options or
p.000004: the circumstances of the inter-assay during the trial must also be specified in the clinical trial protocol.
p.000004: The examiner and the authorized observer must ensure that the data is of the highest quality possible at the stage of their own
p.000004: collection, and the statistician must ensure uniformity of data during processing. The results of the analyzes must be presented
p.000004: in such a way that they allow the interpretation of clinical relevance by assessing the magnitude of the difference in treatment effect and interval
p.000004: reliability is more than just testing for statistical significance. An estimate of the data omitted from
p.000004: statistical analysis. All such exclusions must be documented so that they can be repeated if necessary
p.000004: analysis.
p.000004: (2) The clinical trial should be conducted in accordance with the clinical trial protocol agreed and signed by
p.000004: the contracting authority and the examiner.
p.000004: (3) The contracting authority and the examiner must agree on any change that occurs during the examination,
p.000004: sign it and add it in addition to the clinical trial protocol (amendment).
...
Social / Age
Searching for indicator age:
(return to top)
p.000004: encoding. Access to both keys is required to merge any data or patterns with the subject's personal information.
p.000004: The anonymized data and samples were originally single or double coded, but there is a link between personal data
p.000004: subjects and unique codes are then deleted. Once a connection has been deleted, it is no longer possible to associate data and samples with
p.000004: to people via encryption keys. "Anonymization" prevents the subject from being re-identified. Since being "anonymized"
p.000004: samples and relevant data cannot relate to the subject. It is not possible to undertake procedures such as sample withdrawal
p.000004: or the return of individual results even at the request of the subject. The use of anonymized data and samples does not allow
p.000004: clinical monitoring, monitoring the subject or adding new data. By deleting the encryption keys that bind the data
p.000004: and specimens with personal information about the subject are provided with additional confidence and privacy protection as this is prevented
p.000004: reidentification of the subject using keys. Anonymous data and samples are never marked with personal information when
p.000004: they collect, nor does the coding key be generated.
p.000004: Therefore, there is no possibility of linking genomic data and samples with individual subjects. In some cases only
p.000004: limited clinical information may be associated with anonymous samples (e.g., samples from diabetic subjects, men,
p.000004: age 50-55 g., cholesterol> mg / dl). Because anonymous samples and relevant data cannot be associated with subjects,
p.000004: it is not possible to undertake procedures such as sample withdrawal, return of individual results, even at the request of the subject.
p.000004: The use of anonymous data and samples does not permit clinical monitoring, monitoring of the subject or supplementation of the data;
p.000004: o) Clinical trial of a drug is any systematic trial of a drug with the aim of finding or confirming it
p.000004: actions, as well as the identification of any side effects of did medication. The clinical trial of the drug includes i
p.000004: clinical part of the study of the bioavailability and bioequivalence of a medicinal product with the aim of determining its effectiveness i
p.000004: harmlessness
p.000004: p) Final Report, Clinical Trial Completion Report, contained in Annex No. IV to this Ordinance
p.000004: presents a detailed description of the test after completion and includes a description of the test methodology, method
p.000004: statistical data processing, description of respondents, presentation and evaluation of statistical analysis results, and critical, ethical,
p.000004: statistical and clinical evaluation of the whole trial;
p.000004: q) Quality control means operational techniques and activities undertaken within the assurance system
p.000004: quality, in order to confirm that all the quality requirements have been met;
p.000004: r) Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and
p.000004: continuously produce and control according to appropriate quality standards in accordance with their purpose;
...
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
...
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Clinical trial protocol Documentation of the investigational medicinal product
p.000004: no no
p.000004: no
p.000004: Part / Side: from-to
p.000004: Researcher brochure / summary of product characteristics
p.000004: Sample Test List
p.000004: Ethics Committee (s) approval Statement of the Professional Collegium / Institution Director
p.000004: GMP certificate
p.000004: Biography of Principal Investigator Proof of Paid Compensation
p.000004: Other documents
p.000004: Number of pages added by the applicant due to lack of space on the form:
p.000004: I declare that the information in the request and the supporting documentation is true and that no important fact that may affect
p.000004: the safety of the participants in the examination and the credibility of the conclusions are not hidden.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
...
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration of medical device:
p.000004: Active substance (s), name (for medicinal products containing the medicinal product or medicinal substances):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: Countries where the medical device is registered and year of registration:
p.000004: no yes
p.000004: the medicinal product being tested contains more active substances:
p.000004: Type of medical device:
p.000004: Class I Class IIa Class IIb Class III
p.000004: In vitro diagnostic medical devices
p.000004: Medical Information:
p.000004: Name, type, model:
p.000004: Label, size, packaging:
p.000004: Proposal for the labeling of the medical device and instructions for use:
p.000004: Clinical trial plan:
p.000004: Yes no
p.000004: Specify the total number:
p.000004: Main objective of the test:
p.000004: Methods:
p.000004: Control system:
p.000004: Organization and method of statistical processing:
p.000004: Other goals:
p.000004: Types of testing:
p.000004: Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Respondents: Healthy volunteers Number of patients: Total number of respondents:
p.000004: Patients Total number of examinees in BiH
p.000004: One center testing
p.000004: In several centers in BiH
p.000004: International multicenter in countries:
p.000004: Length of administration of the tested medical device:
p.000004: Specify the monitoring period:
p.000004: Estimated test duration:
p.000004: Criteria for patient involvement: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including zip code):
p.000004: Name of researcher:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The examination is related to obtaining a certificate for entry in the medical registry
p.000004: funds in BiH:
p.000004: Yes no
p.000004: Clinical trial already approved in other countries: yes no Earth,
p.000004: license number, date of issue:
p.000004: ,,
p.000004: Certificate of Compliance with General and Specific Requirements
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Positive opinion of the Commission for Clinical Trials of BiH
p.000004: Proof of insurance in the event of damage to the person or persons under examination
p.000004: Respondent Information Form and Written Consent
p.000004: yes
p.000004: Proof of paid compensation
p.000004: Excerpt from medical device test plan
p.000004: Researcher's brochure / MS characteristics summary
p.000004: no
p.000004: Part / Side: from-to
p.000004: Report to date harmful or Documentation related to
p.000004: side effects MS input materials
p.000004: Documentation relating to the final product of MS regarding intent and risk
p.000004: Documentation related to the MS drafting process
p.000004: Biography of the principal investigator (s)
p.000004: Other documents
...
Social / Child
Searching for indicator child:
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p.000004: life-threatening, disability, hospital treatment (if not required before), hospital extension
p.000004: treatment, congenital anomalies, or defect at and after birth, or malignancy during the test;
p.000004: ee) Post-marketing intervention clinical trial is a prospective trial in which the drug is administered
p.000004: apply in accordance with the conditions specified in the marketing authorization, which requires additional
p.000004: diagnostic procedures as well as monitoring procedures defined by the clinical trial protocol;
p.000004: ff) Post-marketing non-interventional clinical trial (pharmacoepidemiological study) is a trial
p.000004: in which the drug is administered in accordance with the conditions set out in the marketing authorization of the choice
p.000004: Patients are not predetermined by the clinical trial protocol but fall into current established practice
p.000004: The prescribing is clearly separate from the decision to enroll the patient in the trial. Extra
p.000004: diagnostic or monitoring procedures are not applied and the results obtained are analyzed epidemiologically
p.000004: methods;
p.000004: gg) Test protocol is a document containing the objective, plan and methodology of the test, the method of statistical processing
p.000004: clinical trial data and organization, in accordance with Good Clinical Practice;
p.000004: hh) Respondent's consent is the written statement of the respondent, parent of a minor child, guardian or legal representative,
p.000004: by which he voluntarily confirms his willingness to participate in a particular clinical trial, whether orally and in writing
p.000004: informed of all aspects of the examination that are relevant to the decision to participate. The consent of the respondents is
p.000004: documents using the signed statement of consent of the interviewee with the date of signature;
p.000004: ii) Randomization is the process of engaging subjects in therapy or control groups using random methods
p.000004: election to reduce bias;
p.000004: jj) Standard Operating Procedures (SOPs) are detailed written instructions for implementing each specific situation throughout
p.000004: clinical trials, which allow all functions and activities to be performed equally during a particular clinical trial
p.000004: testing;
p.000004: kk) Certificate of Good Clinical Practice - document confirming knowledge of Good Clinical Practice;
p.000004: ll) Raw data are or certified copies of original observations, clinical findings and other activity data
p.000004: within the clinical trial required for reconstruction and evaluation of the trial. The information provided
p.000004: also include laboratory records, notes, accounts, data obtained through automated instruments, accurate
p.000004: verified copies in the form of photocopies, photographic negatives, microfilms or magnetic media;
p.000004: mm) An Examiner Instruction is a document containing relevant drug information, analytical information,
p.000004: pharmacological-toxicological testing, as well as clinical trials to date of the medicinal product concerned, including
p.000004: data that is relevant to
...
Searching for indicator children:
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p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
p.000004: to a specific group of patients, and that such research is essential for the evaluation of clinical data
p.000004: by questioning individuals who are capable of giving their written consent;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: Opinions of a specialist in pediatrics, with particular reference to clinical, ethical and psychosocial
p.000004: problems in conducting a clinical trial of a drug.
p.000004: (4) During the conduct of a clinical trial of a drug, an able-bodied juvenile shall form an opinion and evaluate it
p.000004: The information he has received about participating in a clinical trial may make the decision to take any
p.000004: at the time of withdrawal or withdrawal from the clinical trial of the drug, which shall be reported to the principal investigator or member
p.000004: research team.
p.000004: (5) The applicant / client is in the process of approving a clinical trial of a medicinal product intended for children
p.000004: obliged to submit to the Commission the positive opinion of the Entity Ministries of Health / Health and the Department of Health
p.000004: Brcko District.
p.000004: Article 16
p.000004: (Specific requirements for clinical trial of an adult drug)
p.000004: (1) Clinical trial of a drug by an adult respondent who is unable to obtain legally valid informed consent
p.000004: (unconsciousness, limited physical or mental capacity, etc.), ie on adult respondent who did not refuse
p.000004: consent to participate in a clinical trial of a drug prior to the onset of its incapacity shall be subject to conditions
p.000004: prescribed by law and this regulation.
p.000004: (2) In addition to the conditions "referred to in paragraph (1) of this Article", a clinical trial of a medicinal product may also be conducted if:
p.000004: a) legal representative of an adult respondent who is unable to give legally valid informed consent in writing
p.000004: consent. The written consent of the sea represents the presumed desire of the respondent and can be withdrawn at any
p.000004: moment, without harm to him;
...
p.000004: (1) If the applicant for a clinical trial of a medical device does not receive a negative response from the Agency
p.000004: Within 30 days from the date of submission of the request, it shall be deemed that the clinical trial of the medical device may commence.
p.000004: (2) If the clinical trial is refused, the Agency shall be obliged not later than 30 days from the receipt of the complete
p.000004: to request a permit for clinical trial of a medical device to make a decision with the justified reasons why
p.000004: the request is denied. The decision is finally in administrative procedure and no appeal is allowed, but it can be initiated
p.000004: administrative dispute before a competent court.
p.000004: (3) The time limit referred to in "paragraph (2) of this Article" shall expire on the day on which the Agency submits the applicant for clinical trial
p.000004: request the necessary additional information or explanations and the interruption of the deadline will continue until the request of the Agency is fulfilled.
p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000004: (2) The amount of compensation for the work of the members of the Commission shall be determined by a decision of the Agency and shall be borne by the proposer
p.000004: testing.
p.000004: Article 8
p.000004: (Contents of request for clinical trial of drug)
p.000004: The following shall be attached to the application for authorization to conduct a clinical trial of a medicinal product and a medical device
p.000004: documentation:
p.000004: a) a cover letter with a mandatory list of documents with the date and signature of the applicant;
p.000004: b) the completed clinical trial authorization form for the medicinal product or medical device which is in Annex (I) of this
p.000004: Of the Rules and forms an integral part thereof;
p.000004: c) information on the sponsor of the study;
p.000004: d) a contractual research organization (CRO) authorization letter;
p.000004: logo, name and address of the examiner (logo if any); the name of the professional institution that will participate in the
p.000004: examination, including the approval of the Ethics Committee (s) of the professional institution certifying participation in the
p.000004: the present clinical trial;
p.000004: e) the name of the clinical trial;
p.000004: f) the name of the medicinal product to be tested;
p.000004: g) pharmaceutical form and strength;
p.000004: h) "ATC" - classification, if any;
p.000004: i) the name of the manufacturer;
p.000004: j) proof of payment of the costs of the proceedings;
p.000004: k) a statement of the purpose of the study, the indication of the test phase and the registration status of the medicinal product;
p.000004: l) summary of the clinical study protocol in the local language;
p.000004: m) the clinical trial plan (protocol) with the date and signature of the principal investigator for that clinical trial;
p.000004: n) booklet for the researcher in the local language;
p.000004: o) evidence of the subject's insurance against the potential adverse consequences of participating in the clinical trial; and
p.000004: a medical device that must cover the complete clinical trial period - local insurance (in which case
p.000004: there are data on the number of centers and the number of respondents);
p.000004: p) current knowledge of adverse effects;
p.000004: q) a form for reporting serious adverse drug reactions;
p.000004: r) a list of countries where a clinical trial is being conducted, including Bosnia and Herzegovina, if multicenter;
p.000004: s) a list of countries where the study drug is registered;
p.000004: t) the CRP Case Report Form test lists;
p.000004: u) notification for the respondent in the local language;
p.000004: v) Respondent's consent form with the place of signature of the patient and the principal investigator and the place for the date at
p.000004: local language;
p.000004: w) card of the patient participating in the study;
p.000004: x) "CV" of the researcher;
p.000004: y) evidence of education in the field of good clinical practice for the principal investigator.
p.000004: Article 9
p.000004: (Appointment of Principal Investigator and Clinical Trial Investigator)
p.000004: (1) The principal investigator for clinical trials shall appoint a medical doctor or
p.000004: of dentist.
p.000004: (2) The principal investigator may be assigned to a maximum of three clinical studies during one calendar year.
p.000004: Article 10
p.000004: (Contents of the documentation for the drug under study)
p.000004: The documentation for the drug under study contains:
p.000004: a) a certificate of good manufacturing practice;
p.000004: b) Certificate of completed drug analysis;
p.000004: c) drug labeling;
p.000004: d) evidence of completed pharmacochemical tests with a positive evaluation;
p.000004: e) evidence of a positive pharmacological-toxicological study;
p.000004: f) evidence of the registration status of the medicinal product in the manufacturer's country;
p.000004: g) summary of product characteristics and package leaflet.
p.000004: Article 11
p.000004: (Contents of clinical trial protocol)
p.000004: (1) The clinical trial protocol shall contain: general information; random selection and "blind" testing and statistical
p.000004: analysis.
p.000004: a) general information includes the name of the clinical trial, identification number and date. Accessories must have their own
...
p.000004: concerning the tests, including certificates on how to perform the procedures 5 years after the end of the clinical trials,
p.000004: that is, even after the said deadline, if other applicable criteria or agreements between the contracting authorities so require
p.000004: examiners and examiners.
p.000004: Article 31
p.000004: (Examiner's obligations)
p.000004: (1) The examiner shall be responsible for strictly implementing the clinical trial protocol as follows:
p.000004: a) The examiner may not make any changes to the approved test except in the case of a direct procedure if necessary
p.000004: to eliminate the obvious imminent risk or danger to the respondents by obligatory notifying the Agency thereof;
p.000004: b) in the case of annexes to the clinical trial protocol, the prior approval of the Commission shall be obtained;
p.000004: c) the form of the annexes to the protocol related to the conduct of the clinical trial of the medicinal product has the prescribed contents in Annex no.
p.000004: (III) and is an integral part of this Regulation;
p.000004: d) the examiner must provide appropriate information to the subjects in the clinical trial and comply with the provisions
p.000004: The Declaration of Helsinki and the International Ethical Guidelines for Human Biomedical Testing;
p.000004: e) The nature of the information to be communicated to the subjects depends on the complexity of the clinical trial and the type of drug
p.000004: being examined;
p.000004: f) the information "referred to in point e) of this paragraph" shall, as a rule, be given both verbally and in writing and in a language which is
p.000004: understandable to the respondent;
p.000004: g) the examiner is obliged to inform the subjects about their participation in the clinical trial, to mark the persons from whom
p.000004: may request assistance in an emergency, and alert to the need to keep the said information with them;
p.000004: h) the examiner must be aware of the properties and effects, including information obtained prior to the clinical trial, o
p.000004: the product being tested clinically;
p.000004: i) the examiner must be aware of all relevant new product information that appears during the clinical course
p.000004: testing;
p.000004: j) in the case of a serious undesirable effect, the examiner must inform the proposer of the test without delay,
p.000004: the professional institution where the clinical trial is conducted and through the applicant the Agency;
p.000004: k) the examiner must be available at periodic visits by the competent observer and during the supervision
p.000004: the pharmaceutical inspector as well as the persons designated by the test proponent for quality assurance.
p.000004: (2) The examiner must ensure that:
p.000004: a) safe treatment with the medicinal product being tested during and after the test;
p.000004: b) that the investigational medicinal product is used only in accordance with the clinical trial protocol and is being tested
p.000004: include respondents who are responsible to the examiner;
p.000004: c) the dose and instructions for use are appropriate and understood by each subject;
p.000004: d) that the unused drug under test be returned or destroyed and the notes made on it
p.000004: keep activities according to the test protocol.
p.000004: Article 32
p.000004: (Obligations of the contracting authority)
...
Social / Marital Status
Searching for indicator single:
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p.000004: e) Pharmacodynamics is the study of the interaction between a drug and its molecular targets;
p.000004: f) Genes are functional segments of genetic material that serve as a schematic blueprint for protein synthesis;
p.000004: g) A genome is the total genetic material of an organism;
p.000004: h) The Institutional Ethics Committee is an independent, advisory body whose duty is to evaluate the justification
p.000004: clinical trial, as well as the possibility of conducting a clinical trial according to the principles of Good Clinical Practice, and all
p.000004: this to ensure and protect the rights, safety and well-being of the subjects involved in the clinical trial;
p.000004: i) The examiner is the person responsible for conducting the clinical trial in the institution where it is conducted;
p.000004: j) The Principal Investigator is the investigator who is responsible for conducting the clinical trial of the medicinal product if clinical
p.000004: drug testing is conducted by the research team;
p.000004: k) The applicant is a person who participates in the clinical trial as a beneficiary of the investigational medicinal product
p.000004: the drug in the trial compares or placebo;
p.000004: l) Clinical Trial Report is a written report of the course of a clinical trial of any therapeutic,
p.000004: a prophylactic or diagnostic product, comprising clinical and statistical data processing, presentation, analysis and
p.000004: conclusions;
p.000004: m) Single or double blind examination means that the candidate does not know what he is receiving or that he does not
p.000004: the respondent, the examiner, or the competent observer do not know what anyone has received.
p.000004: n) Data coding categories
p.000004: Single-coded data and samples are marked with one specific code and do not imply any personal information
p.000004: identifiers. In the case of single coding, data or samples can be linked to a specific person
p.000004: using the encryption key. The clinical investigator is responsible for keeping the coding key. Since the samples and
p.000004: supporting information can be indirectly linked to the research subject, using a coding key, can be taken
p.000004: procedures such as drawing a sample or returning individual results at the request of the subject. Single use
p.000004: coded data and samples allows clinical monitoring, monitoring of the subject or supplementing of the subject's data.
p.000004: Single coding is currently the standard used in clinical research and offers an additional guarantee of
p.000004: subject identifiers, in relation to the general principles of trust in the health care system and privacy protection in
p.000004: daily medical practice;
p.000004: Duplicate encoded data and samples were originally marked with one specific code and did not carry any personal data
p.000004: information.
p.000004: The data and samples are then labeled with a second code that is first linked via the second encryption key. Data or
p.000004: patterns can be linked to the face using both encryption keys. The clinical researcher is responsible for safeguarding the former
p.000004: encryption key and has no access to another key. As samples and corresponding data can be very indirectly linked to
p.000004: subject to the use of both coding keys, procedures such as sample withdrawal or retrieval may be undertaken
p.000004: individual results at the request of the subject.
p.000004: However, additional electronic or technical processes may limit the ability to associate the genotype result with
p.000004: face. E.g. a certain computer procedure may add new data to the subject, but connection is prevented
p.000004: genotype data with the subject's personal information. The use of duplicate encoded data and samples is made possible clinically
p.000004: monitoring, monitoring the subject or supplementing the data.
p.000004: The use of the second code provides additional confidence and protection of the privacy of the entities, greater than that of the single code
p.000004: encoding. Access to both keys is required to merge any data or patterns with the subject's personal information.
p.000004: The anonymized data and samples were originally single or double coded, but there is a link between personal data
p.000004: subjects and unique codes are then deleted. Once a connection has been deleted, it is no longer possible to associate data and samples with
p.000004: to people via encryption keys. "Anonymization" prevents the subject from being re-identified. Since being "anonymized"
p.000004: samples and relevant data cannot relate to the subject. It is not possible to undertake procedures such as sample withdrawal
p.000004: or the return of individual results even at the request of the subject. The use of anonymized data and samples does not allow
p.000004: clinical monitoring, monitoring the subject or adding new data. By deleting the encryption keys that bind the data
p.000004: and specimens with personal information about the subject are provided with additional confidence and privacy protection as this is prevented
p.000004: reidentification of the subject using keys. Anonymous data and samples are never marked with personal information when
p.000004: they collect, nor does the coding key be generated.
p.000004: Therefore, there is no possibility of linking genomic data and samples with individual subjects. In some cases only
p.000004: limited clinical information may be associated with anonymous samples (e.g., samples from diabetic subjects, men,
p.000004: age 50-55 g., cholesterol> mg / dl). Because anonymous samples and relevant data cannot be associated with subjects,
p.000004: it is not possible to undertake procedures such as sample withdrawal, return of individual results, even at the request of the subject.
p.000004: The use of anonymous data and samples does not permit clinical monitoring, monitoring of the subject or supplementation of the data;
p.000004: o) Clinical trial of a drug is any systematic trial of a drug with the aim of finding or confirming it
p.000004: actions, as well as the identification of any side effects of did medication. The clinical trial of the drug includes i
p.000004: clinical part of the study of the bioavailability and bioequivalence of a medicinal product with the aim of determining its effectiveness i
p.000004: harmlessness
p.000004: p) Final Report, Clinical Trial Completion Report, contained in Annex No. IV to this Ordinance
p.000004: presents a detailed description of the test after completion and includes a description of the test methodology, method
p.000004: statistical data processing, description of respondents, presentation and evaluation of statistical analysis results, and critical, ethical,
p.000004: statistical and clinical evaluation of the whole trial;
p.000004: q) Quality control means operational techniques and activities undertaken within the assurance system
p.000004: quality, in order to confirm that all the quality requirements have been met;
p.000004: r) Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and
p.000004: continuously produce and control according to appropriate quality standards in accordance with their purpose;
p.000004: s) Multicenter clinical trial is a clinical trial conducted according to a single protocol
p.000004: a multi-center clinical trial run by multiple examiners, with the centers where the tests are being conducted
p.000004: may be located in one or more countries;
p.000004: t) Surveillance is a systematic test conducted (as a rule on a randomly selected sample of data) by a trained person.
p.000004: which does not directly participate in the trial in order to determine whether the clinical trial in question is being conducted according to
p.000004: approved plan
p.000004: trials, in accordance with standard operating procedures and Good Clinical Practice. It is monitored by the monitor it has
p.000004: appropriate qualifications to perform clinical trial monitor jobs and have good clinical education
p.000004: practice;
p.000004: u) Competent observer is a qualified person who independently assesses the conformity of all on behalf of the contracting authority
p.000004: activities related to clinical trial, protocol, standard operating procedures, Good
p.000004: clinical practice and with applicable regulations;
p.000004: v) The client of the trial is the legal entity at whose request the clinical trial is conducted;
p.000004: w) Adverse drug action is any adverse and unintentionally triggered reaction that may occur during a therapeutic
p.000004: dose of the drug. A side effect of a drug can also be defined as any adverse reaction to a drug that has been administered
p.000004: at the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological functions, with
...
p.000004: Active substance (s), name (for radiopharmaceuticals - radionuclide)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Clinical trial protocol Documentation of the investigational medicinal product
p.000004: no no
p.000004: no
p.000004: Part / Side: from-to
p.000004: Researcher brochure / summary of product characteristics
p.000004: Sample Test List
p.000004: Ethics Committee (s) approval Statement of the Professional Collegium / Institution Director
p.000004: GMP certificate
p.000004: Biography of Principal Investigator Proof of Paid Compensation
p.000004: Other documents
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000004: life-threatening, disability, hospital treatment (if not required before), hospital extension
p.000004: treatment, congenital anomalies, or defect at and after birth, or malignancy during the test;
p.000004: ee) Post-marketing intervention clinical trial is a prospective trial in which the drug is administered
p.000004: apply in accordance with the conditions specified in the marketing authorization, which requires additional
p.000004: diagnostic procedures as well as monitoring procedures defined by the clinical trial protocol;
p.000004: ff) Post-marketing non-interventional clinical trial (pharmacoepidemiological study) is a trial
p.000004: in which the drug is administered in accordance with the conditions set out in the marketing authorization of the choice
p.000004: Patients are not predetermined by the clinical trial protocol but fall into current established practice
p.000004: The prescribing is clearly separate from the decision to enroll the patient in the trial. Extra
p.000004: diagnostic or monitoring procedures are not applied and the results obtained are analyzed epidemiologically
p.000004: methods;
p.000004: gg) Test protocol is a document containing the objective, plan and methodology of the test, the method of statistical processing
p.000004: clinical trial data and organization, in accordance with Good Clinical Practice;
p.000004: hh) Respondent's consent is the written statement of the respondent, parent of a minor child, guardian or legal representative,
p.000004: by which he voluntarily confirms his willingness to participate in a particular clinical trial, whether orally and in writing
p.000004: informed of all aspects of the examination that are relevant to the decision to participate. The consent of the respondents is
p.000004: documents using the signed statement of consent of the interviewee with the date of signature;
p.000004: ii) Randomization is the process of engaging subjects in therapy or control groups using random methods
p.000004: election to reduce bias;
p.000004: jj) Standard Operating Procedures (SOPs) are detailed written instructions for implementing each specific situation throughout
p.000004: clinical trials, which allow all functions and activities to be performed equally during a particular clinical trial
p.000004: testing;
p.000004: kk) Certificate of Good Clinical Practice - document confirming knowledge of Good Clinical Practice;
p.000004: ll) Raw data are or certified copies of original observations, clinical findings and other activity data
p.000004: within the clinical trial required for reconstruction and evaluation of the trial. The information provided
p.000004: also include laboratory records, notes, accounts, data obtained through automated instruments, accurate
p.000004: verified copies in the form of photocopies, photographic negatives, microfilms or magnetic media;
p.000004: mm) An Examiner Instruction is a document containing relevant drug information, analytical information,
p.000004: pharmacological-toxicological testing, as well as clinical trials to date of the medicinal product concerned, including
p.000004: data that is relevant to
...
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
p.000004: to a specific group of patients, and that such research is essential for the evaluation of clinical data
p.000004: by questioning individuals who are capable of giving their written consent;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: Opinions of a specialist in pediatrics, with particular reference to clinical, ethical and psychosocial
p.000004: problems in conducting a clinical trial of a drug.
p.000004: (4) During the conduct of a clinical trial of a drug, an able-bodied juvenile shall form an opinion and evaluate it
p.000004: The information he has received about participating in a clinical trial may make the decision to take any
...
p.000004: the request is denied. The decision is finally in administrative procedure and no appeal is allowed, but it can be initiated
p.000004: administrative dispute before a competent court.
p.000004: (3) The time limit referred to in "paragraph (2) of this Article" shall expire on the day on which the Agency submits the applicant for clinical trial
p.000004: request the necessary additional information or explanations and the interruption of the deadline will continue until the request of the Agency is fulfilled.
p.000004: (4) For the purpose of protecting the health of the population, the Agency may determine the temporary or permanent termination of a clinical trial.
p.000004: (5) The Agency may determine the supervision of the conduct of the clinical trial of the medical device and the observance of the principles
p.000004: good practice in clinical trial in accordance with the Law.
p.000004: Article 37
p.000004: (Conditions for clinical testing of a medicinal product by specific persons)
p.000004: (1) A clinical trial of a medical device may be performed only with the written consent-consent of the person on whom
p.000004: the test is performed.
p.000004: (2) Clinical testing of a medical device on children may be performed only if the examination in adults is personal
p.000004: can provide appropriate results.
p.000004: (3) In exceptional cases, for a person who is not conscious, with severe mental disability, for a business incapable person
p.000004: or a minor, written consent is given by the legal representative or legal guardian of the person.
p.000004: (4) A clinical trial must not be performed if the potential risk of using a medical device is greater than
p.000004: the health justification for testing the medical device, as assessed by the Commission or the Director of the Agency.
p.000004: (5) Clinical trials should not be carried out on prisoners and on persons who may be influenced by coercion
p.000004: consent to participate in a clinical trial of a medical device.
p.000004: Article 38
p.000004: (Costs and persons authorized to report clinical trial of medical device)
p.000004: (1) Prior to the commencement of the clinical trial of a medical device in the territory of BiH, the intended clinical trial
p.000004: the medical device must be reported to the Agency.
p.000004: (2) The applicant for the clinical trial of a medical device may be a sponsor, manufacturer or importer
p.000004: or on his behalf the principal investigator of a clinical trial of a medical device.
p.000004: (3) It shall bear the costs of the clinical trial and consideration of the application of the clinical trial of the medical device
p.000004: the applicant for the clinical trial.
p.000004: (4) Agency or Entity Ministries of Health or Department of Health of the Brcko District, other state or
p.000004: the entity ministry or other legal entity may require a clinical trial of the medical device for use
p.000004: protection of population health.
p.000004: (5) The costs of testing shall be borne by the proponent of the clinical trial only if it is demonstrated that the safety is effective
...
p.000004: as a whole.
p.000004: 7. Doctors are not allowed to undertake scientific projects on humans until they are convinced that they can be trusted
p.000004: predictability of possible risks. Doctors must stop any testing if the dangers are found to be greater than
p.000004: potential benefits.
p.000004: 8. When publishing the results of their examination, doctors are obliged to respect the accuracy of the results. Report on
p.000004: examination which does not comply with the principles of this declaration should not be accepted for publication.
p.000004: 9. In each human test, each individual respondent must be adequately informed of
p.000004: goals, methods, perceived benefit and potential testing risks as well as inconvenience
p.000004: which it may cause. The respondent should be informed of the freedom to withdraw from the examination and yes
p.000004: he comes out of questioning whenever he wants. Thereafter, the physician should be given the testimony freely given
p.000004: consent, preferably in writing.
p.000004: 10. When obtaining a test consent, the physician must be especially careful if the subject is dependent on it
p.000004: position or give consent under pressure. In this case, consent should be given to a physician who is not involved
p.000004: into the examination and which is completely independent.
p.000004: 11. If the respondent is not legally competent consent should be obtained from his legal representative in accordance with
p.000004: national legislation. Whenever a minor is in a position to give consent, it must be obtained with his consent
p.000004: legal representative.
p.000004: 12. The test plan must always include a statement of ethical elements and indicate that they are
p.000004: the principles of this declaration were respected.
p.000004: II Medical examination combined with professional supervision (clinical trial)
p.000004: 1. In treating a patient, the physician must be able to use new diagnostic and therapeutic measures, if any
p.000004: in his view, they offer hope for saving lives, restoring health and reducing suffering.
p.000004: 2. The potential benefits, dangers and inconveniences of the new method must be weighed against the benefits
p.000004: the best standard diagnostic and therapeutic methods.
p.000004: 3. In each clinical study, each patient, including one in the control group, should have, if available,
p.000004: the best, most proven diagnostic and therapeutic method available. That, in cases where there is no proven
p.000004: diagnostic or therapeutic methods, does not exclude the use of placebo.
p.000004: 4. A patient's refusal to participate in the examination should never affect his or her relationship with the physician.
p.000004: 5. If the doctor deems it necessary not to obtain consent, the specific reasons for this must be stated in the plan
p.000004: (protocol) tests, to be submitted to an independent representative.
p.000004: 6. The physician may combine medical examination with professional supervision in order to acquire new medical knowledge
p.000004: only to the extent that the test is justified in terms of its potential diagnostic or therapeutic
...
Social / education
Searching for indicator education:
(return to top)
p.000004: harmlessness
p.000004: p) Final Report, Clinical Trial Completion Report, contained in Annex No. IV to this Ordinance
p.000004: presents a detailed description of the test after completion and includes a description of the test methodology, method
p.000004: statistical data processing, description of respondents, presentation and evaluation of statistical analysis results, and critical, ethical,
p.000004: statistical and clinical evaluation of the whole trial;
p.000004: q) Quality control means operational techniques and activities undertaken within the assurance system
p.000004: quality, in order to confirm that all the quality requirements have been met;
p.000004: r) Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and
p.000004: continuously produce and control according to appropriate quality standards in accordance with their purpose;
p.000004: s) Multicenter clinical trial is a clinical trial conducted according to a single protocol
p.000004: a multi-center clinical trial run by multiple examiners, with the centers where the tests are being conducted
p.000004: may be located in one or more countries;
p.000004: t) Surveillance is a systematic test conducted (as a rule on a randomly selected sample of data) by a trained person.
p.000004: which does not directly participate in the trial in order to determine whether the clinical trial in question is being conducted according to
p.000004: approved plan
p.000004: trials, in accordance with standard operating procedures and Good Clinical Practice. It is monitored by the monitor it has
p.000004: appropriate qualifications to perform clinical trial monitor jobs and have good clinical education
p.000004: practice;
p.000004: u) Competent observer is a qualified person who independently assesses the conformity of all on behalf of the contracting authority
p.000004: activities related to clinical trial, protocol, standard operating procedures, Good
p.000004: clinical practice and with applicable regulations;
p.000004: v) The client of the trial is the legal entity at whose request the clinical trial is conducted;
p.000004: w) Adverse drug action is any adverse and unintentionally triggered reaction that may occur during a therapeutic
p.000004: dose of the drug. A side effect of a drug can also be defined as any adverse reaction to a drug that has been administered
p.000004: at the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological functions, with
p.000004: the condition that there is a cause and effect relationship, or that relationship cannot be ruled out;
p.000004: x) Adverse drug reaction in a clinical trial is an undesirable and unintentionally induced reaction in a subject,
p.000004: which may occur in a clinical trial of a drug in connection with any dose of the drug;
p.000004: y) An unexpected side effect of a drug is one that has an unknown nature, severity or outcome,
p.000004: that is, they are not described in the Summary of Product Characteristics and Package Leaflet, or are not part of this effect
...
p.000004: k) a statement of the purpose of the study, the indication of the test phase and the registration status of the medicinal product;
p.000004: l) summary of the clinical study protocol in the local language;
p.000004: m) the clinical trial plan (protocol) with the date and signature of the principal investigator for that clinical trial;
p.000004: n) booklet for the researcher in the local language;
p.000004: o) evidence of the subject's insurance against the potential adverse consequences of participating in the clinical trial; and
p.000004: a medical device that must cover the complete clinical trial period - local insurance (in which case
p.000004: there are data on the number of centers and the number of respondents);
p.000004: p) current knowledge of adverse effects;
p.000004: q) a form for reporting serious adverse drug reactions;
p.000004: r) a list of countries where a clinical trial is being conducted, including Bosnia and Herzegovina, if multicenter;
p.000004: s) a list of countries where the study drug is registered;
p.000004: t) the CRP Case Report Form test lists;
p.000004: u) notification for the respondent in the local language;
p.000004: v) Respondent's consent form with the place of signature of the patient and the principal investigator and the place for the date at
p.000004: local language;
p.000004: w) card of the patient participating in the study;
p.000004: x) "CV" of the researcher;
p.000004: y) evidence of education in the field of good clinical practice for the principal investigator.
p.000004: Article 9
p.000004: (Appointment of Principal Investigator and Clinical Trial Investigator)
p.000004: (1) The principal investigator for clinical trials shall appoint a medical doctor or
p.000004: of dentist.
p.000004: (2) The principal investigator may be assigned to a maximum of three clinical studies during one calendar year.
p.000004: Article 10
p.000004: (Contents of the documentation for the drug under study)
p.000004: The documentation for the drug under study contains:
p.000004: a) a certificate of good manufacturing practice;
p.000004: b) Certificate of completed drug analysis;
p.000004: c) drug labeling;
p.000004: d) evidence of completed pharmacochemical tests with a positive evaluation;
p.000004: e) evidence of a positive pharmacological-toxicological study;
p.000004: f) evidence of the registration status of the medicinal product in the manufacturer's country;
p.000004: g) summary of product characteristics and package leaflet.
p.000004: Article 11
p.000004: (Contents of clinical trial protocol)
p.000004: (1) The clinical trial protocol shall contain: general information; random selection and "blind" testing and statistical
p.000004: analysis.
p.000004: a) general information includes the name of the clinical trial, identification number and date. Accessories must have their own
p.000004: number and date. The general information contains the name and address of the examiner and the competent observer, the names of the persons who will
p.000004: sign the clinical trial protocol and annexes on behalf of the trial sponsor and examiner responsible for
...
p.000004: informs the principal investigator or member of the research team.
p.000004: Article 17
p.000004: (Respondent's health care)
p.000004: The respondent must be provided with adequate health care for the duration of the examination. Health care
p.000004: must also be ensured after examination in a period that depends on the nature of the disease, the manner of testing and the tests done
p.000004: interventions.
p.000004: Article 18
p.000004: (Clinical trial site and staff)
p.000004: (1) The clinical trial shall be conducted under conditions that guarantee the safety of the subjects.
p.000004: (2) The choice of clinical trial site depends on the degree of product development and the associated potential risks.
p.000004: (3) In the case of clinical trials aimed at entering the genome of subjects for exercise
p.000004: pharmacogenomic and pharmacogenetic knowledge, the same can only be carried out if the required samples and data are provided
p.000004: anonymity or anonymity.
p.000004: (4) The clinical trial site must have adequate personnel, facilities and equipment, including laboratories.
p.000004: (5) In the composition of the research team in the clinical trial of the medicinal product being carried out in the healthcare institution providing it
p.000004: secondary or tertiary health care must be included by a medical doctor-specialist in clinical
p.000004: pharmacology, when the first phase of clinical trial of the drug is being conducted.
p.000004: (6) In certain parts of the clinical trial of the medicinal product, in addition to the medical doctor and the doctor of dentistry,
p.000004: these include professionals with other relevant education (pharmacists, specialists)
p.000004: medical biochemists or clinical biochemists, statisticians, nurses, health technicians, and
p.000004: Dr.).
p.000004: Article 19
p.000004: (Multicenter drug test)
p.000004: (1) In the case of a multicenter trial, the study of the drug shall be carried out simultaneously with several examiners, at
p.000004: different sites, based on the same clinical trial protocol.
p.000004: (2) Multicenter testing "referred to in paragraph (1) of this Article" requires a special administrative system whose form depends
p.000004: of the number of study sites, test endpoints, and available information on the drug being tested.
p.000004: (3) The multicenter examination protocol shall describe the functions, responsibilities, rights and obligations of all
p.000004: participants in the clinical trial procedure.
p.000004: (4) In the case of multicenter examination, it is permissible to establish a coordinating committee or coordinator s
p.000004: responsibility for overseeing the practical conduct and progress of testing and maintaining contacts with the Agency, a professional
p.000004: the institution where the clinical trial is being conducted, as well as other competent authorities in this field.
p.000004: Article 20
p.000004: (Notification of clinical trial)
p.000004: The test proponent should regularly inform the Agency and the authorized institution where the flow test is being conducted
p.000004: and the results of the trial, at the conclusion of each phase of the clinical trial.
p.000004: Article 21
p.000004: (Suspension and prohibition of clinical trial of the drug)
p.000004: (1) While conducting a clinical trial, the Agency may suspend or suspend a clinical trial at
...
Social / gender
Searching for indicator gender:
(return to top)
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
p.000004: date of issue:
p.000004: ,,
p.000004: Clinical trial of the active substance
p.000004: Reported in BiH yes no Rejected in BiH yes
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Clinical trial protocol Documentation of the investigational medicinal product
p.000004: no no
p.000004: no
p.000004: Part / Side: from-to
p.000004: Researcher brochure / summary of product characteristics
p.000004: Sample Test List
p.000004: Ethics Committee (s) approval Statement of the Professional Collegium / Institution Director
p.000004: GMP certificate
p.000004: Biography of Principal Investigator Proof of Paid Compensation
p.000004: Other documents
p.000004: Number of pages added by the applicant due to lack of space on the form:
p.000004: I declare that the information in the request and the supporting documentation is true and that no important fact that may affect
p.000004: the safety of the participants in the examination and the credibility of the conclusions are not hidden.
p.000004: Name and surname of the responsible person
...
p.000004: Country, year and certificate number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration of medical device:
p.000004: Active substance (s), name (for medicinal products containing the medicinal product or medicinal substances):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: Countries where the medical device is registered and year of registration:
p.000004: no yes
p.000004: the medicinal product being tested contains more active substances:
p.000004: Type of medical device:
p.000004: Class I Class IIa Class IIb Class III
p.000004: In vitro diagnostic medical devices
p.000004: Medical Information:
p.000004: Name, type, model:
p.000004: Label, size, packaging:
p.000004: Proposal for the labeling of the medical device and instructions for use:
p.000004: Clinical trial plan:
p.000004: Yes no
p.000004: Specify the total number:
p.000004: Main objective of the test:
p.000004: Methods:
p.000004: Control system:
p.000004: Organization and method of statistical processing:
p.000004: Other goals:
p.000004: Types of testing:
p.000004: Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Respondents: Healthy volunteers Number of patients: Total number of respondents:
p.000004: Patients Total number of examinees in BiH
p.000004: One center testing
p.000004: In several centers in BiH
p.000004: International multicenter in countries:
p.000004: Length of administration of the tested medical device:
p.000004: Specify the monitoring period:
p.000004: Estimated test duration:
p.000004: Criteria for patient involvement: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including zip code):
p.000004: Name of researcher:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The examination is related to obtaining a certificate for entry in the medical registry
p.000004: funds in BiH:
p.000004: Yes no
p.000004: Clinical trial already approved in other countries: yes no Earth,
p.000004: license number, date of issue:
p.000004: ,,
p.000004: Certificate of Compliance with General and Specific Requirements
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Positive opinion of the Commission for Clinical Trials of BiH
p.000004: Proof of insurance in the event of damage to the person or persons under examination
p.000004: Respondent Information Form and Written Consent
p.000004: yes
p.000004: Proof of paid compensation
p.000004: Excerpt from medical device test plan
p.000004: Researcher's brochure / MS characteristics summary
p.000004: no
p.000004: Part / Side: from-to
p.000004: Report to date harmful or Documentation related to
p.000004: side effects MS input materials
p.000004: Documentation relating to the final product of MS regarding intent and risk
p.000004: Documentation related to the MS drafting process
p.000004: Biography of the principal investigator (s)
p.000004: Other documents
...
Social / parents
Searching for indicator parent:
(return to top)
p.000004: life-threatening, disability, hospital treatment (if not required before), hospital extension
p.000004: treatment, congenital anomalies, or defect at and after birth, or malignancy during the test;
p.000004: ee) Post-marketing intervention clinical trial is a prospective trial in which the drug is administered
p.000004: apply in accordance with the conditions specified in the marketing authorization, which requires additional
p.000004: diagnostic procedures as well as monitoring procedures defined by the clinical trial protocol;
p.000004: ff) Post-marketing non-interventional clinical trial (pharmacoepidemiological study) is a trial
p.000004: in which the drug is administered in accordance with the conditions set out in the marketing authorization of the choice
p.000004: Patients are not predetermined by the clinical trial protocol but fall into current established practice
p.000004: The prescribing is clearly separate from the decision to enroll the patient in the trial. Extra
p.000004: diagnostic or monitoring procedures are not applied and the results obtained are analyzed epidemiologically
p.000004: methods;
p.000004: gg) Test protocol is a document containing the objective, plan and methodology of the test, the method of statistical processing
p.000004: clinical trial data and organization, in accordance with Good Clinical Practice;
p.000004: hh) Respondent's consent is the written statement of the respondent, parent of a minor child, guardian or legal representative,
p.000004: by which he voluntarily confirms his willingness to participate in a particular clinical trial, whether orally and in writing
p.000004: informed of all aspects of the examination that are relevant to the decision to participate. The consent of the respondents is
p.000004: documents using the signed statement of consent of the interviewee with the date of signature;
p.000004: ii) Randomization is the process of engaging subjects in therapy or control groups using random methods
p.000004: election to reduce bias;
p.000004: jj) Standard Operating Procedures (SOPs) are detailed written instructions for implementing each specific situation throughout
p.000004: clinical trials, which allow all functions and activities to be performed equally during a particular clinical trial
p.000004: testing;
p.000004: kk) Certificate of Good Clinical Practice - document confirming knowledge of Good Clinical Practice;
p.000004: ll) Raw data are or certified copies of original observations, clinical findings and other activity data
p.000004: within the clinical trial required for reconstruction and evaluation of the trial. The information provided
p.000004: also include laboratory records, notes, accounts, data obtained through automated instruments, accurate
p.000004: verified copies in the form of photocopies, photographic negatives, microfilms or magnetic media;
p.000004: mm) An Examiner Instruction is a document containing relevant drug information, analytical information,
...
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
p.000004: to a specific group of patients, and that such research is essential for the evaluation of clinical data
p.000004: by questioning individuals who are capable of giving their written consent;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: Opinions of a specialist in pediatrics, with particular reference to clinical, ethical and psychosocial
...
Searching for indicator parents:
(return to top)
p.000004: knowledge of test details;
p.000004: d) the information "referred to in paragraph (3) of this Article" must contain a clear message that it is an examination, that participation
p.000004: in the clinical trial is voluntary and that refusal to participate, that is, refusal to participate in the trial
p.000004: freely;
p.000004: e) respondents must have sufficient time to decide whether or not they wish to participate in the examination;
p.000004: f) the subjects must be aware and agree to check the test results and be aware that it is
p.000004: participation in the examination protected as professional secrecy and as such made available to the public;
p.000004: g) the candidate must be informed about the insurance and treatment procedures for treatment in case of damage or
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
p.000004: (3) In addition to the conditions "referred to in paragraphs (1) and (2) of this Article", a clinical trial of a drug in a juvenile subject may be
p.000004: implement if:
p.000004: a) the parent or legal guardian has given written consent (the written consent must represent the presumed one
p.000004: the will of the minor and may be withdrawn at any time, without prejudice to the minor);
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000004: the request of the competent ministry;
p.000004: (2) The test client is responsible for the reliability of the data and information made available to the examiner
p.000004: before the start of the clinical trial, or those that occur during the trial;
p.000004: (3) The investigator and the examiner are obliged to cooperate with the authorized institution where the clinical
p.000004: testing regarding reporting, implementation of changes to clinical trial protocols, reporting adverse events, and
p.000004: submission of test reports;
p.000004: (4) The contracting authority shall organize a quality assurance system (including independent supervision) for implementation
p.000004: testing;
p.000004: (5) The contracting authority shall prepare written detailed standard operating procedures (SOPs), in accordance with Good
p.000004: clinical practice;
p.000004: (6) The investigator and the examiner must agree and sign the clinical trial protocol, and
p.000004: determine the method of data entry.
p.000004: Article 6
p.000004: (Authorization for clinical trial of a medicinal product)
p.000004: (1) Each clinical trial of a medicinal product must be approved by the Agency for Medicinal Products and Medical Devices of Bosnia
p.000004: and Herzegovina (hereinafter: the Agency);
p.000004: (2) Prior to granting a license to conduct a clinical trial of a medicinal product "referred to in paragraph (2) of this Article"
p.000004: obtain the approval of the Clinical Trials Committee for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: (the Commission);
p.000004: (3) The Agency is obliged to issue a clinical trial authorization within 60 days from the date of admission
p.000004: a formal request, based on the Commission's opinion.
p.000004: Article 7
p.000004: (Costs of clinical trial of the drug)
p.000004: (1) The costs of applying for a clinical trial and licensing shall be borne by the applicant for the trial;
p.000004: (2) The amount of compensation for the work of the members of the Commission shall be determined by a decision of the Agency and shall be borne by the proposer
p.000004: testing.
p.000004: Article 8
p.000004: (Contents of request for clinical trial of drug)
p.000004: The following shall be attached to the application for authorization to conduct a clinical trial of a medicinal product and a medical device
p.000004: documentation:
p.000004: a) a cover letter with a mandatory list of documents with the date and signature of the applicant;
p.000004: b) the completed clinical trial authorization form for the medicinal product or medical device which is in Annex (I) of this
p.000004: Of the Rules and forms an integral part thereof;
p.000004: c) information on the sponsor of the study;
p.000004: d) a contractual research organization (CRO) authorization letter;
p.000004: logo, name and address of the examiner (logo if any); the name of the professional institution that will participate in the
p.000004: examination, including the approval of the Ethics Committee (s) of the professional institution certifying participation in the
p.000004: the present clinical trial;
p.000004: e) the name of the clinical trial;
p.000004: f) the name of the medicinal product to be tested;
p.000004: g) pharmaceutical form and strength;
p.000004: h) "ATC" - classification, if any;
p.000004: i) the name of the manufacturer;
p.000004: j) proof of payment of the costs of the proceedings;
...
p.000004: b) the minor has received information in accordance with his or her ability to understand, by a person who has experience in
p.000004: work with minors related to the course of the clinical trial, the risks and health benefits
p.000004: respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: any material stimulation or other benefits;
p.000004: d) the ethics committee has assessed that a clinical trial of the drug on a juvenile subject has a direct benefit for
p.000004: to a specific group of patients, and that such research is essential for the evaluation of clinical data
p.000004: by questioning individuals who are capable of giving their written consent;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: Opinions of a specialist in pediatrics, with particular reference to clinical, ethical and psychosocial
p.000004: problems in conducting a clinical trial of a drug.
p.000004: (4) During the conduct of a clinical trial of a drug, an able-bodied juvenile shall form an opinion and evaluate it
p.000004: The information he has received about participating in a clinical trial may make the decision to take any
p.000004: at the time of withdrawal or withdrawal from the clinical trial of the drug, which shall be reported to the principal investigator or member
p.000004: research team.
p.000004: (5) The applicant / client is in the process of approving a clinical trial of a medicinal product intended for children
p.000004: obliged to submit to the Commission the positive opinion of the Entity Ministries of Health / Health and the Department of Health
p.000004: Brcko District.
p.000004: Article 16
p.000004: (Specific requirements for clinical trial of an adult drug)
p.000004: (1) Clinical trial of a drug by an adult respondent who is unable to obtain legally valid informed consent
p.000004: (unconsciousness, limited physical or mental capacity, etc.), ie on adult respondent who did not refuse
p.000004: consent to participate in a clinical trial of a drug prior to the onset of its incapacity shall be subject to conditions
p.000004: prescribed by law and this regulation.
p.000004: (2) In addition to the conditions "referred to in paragraph (1) of this Article", a clinical trial of a medicinal product may also be conducted if:
p.000004: a) legal representative of an adult respondent who is unable to give legally valid informed consent in writing
p.000004: consent. The written consent of the sea represents the presumed desire of the respondent and can be withdrawn at any
p.000004: moment, without harm to him;
p.000004: b) an adult candidate who is unable to give written consent has received information to the best of his or her ability
p.000004: to understand, by a person who has experience in working with such persons, relating to the course of the clinical
p.000004: examinations, risk and health benefits of respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: what material or other uses;
p.000004: d) it is estimated that a clinical trial of the medicinal product on that face provides direct benefit to a group of patients whose
p.000004: illness or condition corresponds to illness or condition of the subjects;
p.000004: e) a positive decision to conduct a clinical trial of a drug in a healthcare facility was made by an ethics committee on the basis of
p.000004: the opinion of a specialist doctor for a particular area or condition of the subjects, or for the population of patients to whom
p.000004: clinical trial of the drug relates, with particular reference to clinical, ethical and psycho-social problems in implementation
p.000004: clinical trial of the drug.
p.000004: (3) During the conduct of the clinical trial of a medicinal product, an adult who is unable to provide an informed written person
p.000004: consent, which is able to form an opinion and evaluate the information it has received about participating in the clinical
p.000004: drug test, can be withdrawn at any time, or waived the clinical drug test, of which
p.000004: informs the principal investigator or member of the research team.
p.000004: Article 17
p.000004: (Respondent's health care)
p.000004: The respondent must be provided with adequate health care for the duration of the examination. Health care
p.000004: must also be ensured after examination in a period that depends on the nature of the disease, the manner of testing and the tests done
p.000004: interventions.
p.000004: Article 18
p.000004: (Clinical trial site and staff)
p.000004: (1) The clinical trial shall be conducted under conditions that guarantee the safety of the subjects.
p.000004: (2) The choice of clinical trial site depends on the degree of product development and the associated potential risks.
p.000004: (3) In the case of clinical trials aimed at entering the genome of subjects for exercise
p.000004: pharmacogenomic and pharmacogenetic knowledge, the same can only be carried out if the required samples and data are provided
p.000004: anonymity or anonymity.
p.000004: (4) The clinical trial site must have adequate personnel, facilities and equipment, including laboratories.
p.000004: (5) In the composition of the research team in the clinical trial of the medicinal product being carried out in the healthcare institution providing it
p.000004: secondary or tertiary health care must be included by a medical doctor-specialist in clinical
p.000004: pharmacology, when the first phase of clinical trial of the drug is being conducted.
...
p.000004: participants in the clinical trial procedure.
p.000004: (4) In the case of multicenter examination, it is permissible to establish a coordinating committee or coordinator s
p.000004: responsibility for overseeing the practical conduct and progress of testing and maintaining contacts with the Agency, a professional
p.000004: the institution where the clinical trial is being conducted, as well as other competent authorities in this field.
p.000004: Article 20
p.000004: (Notification of clinical trial)
p.000004: The test proponent should regularly inform the Agency and the authorized institution where the flow test is being conducted
p.000004: and the results of the trial, at the conclusion of each phase of the clinical trial.
p.000004: Article 21
p.000004: (Suspension and prohibition of clinical trial of the drug)
p.000004: (1) While conducting a clinical trial, the Agency may suspend or suspend a clinical trial at
p.000004: in the following cases:
p.000004: a) if it finds that the conditions laid down in the law, in this regulation or in the application for a permit have not been fulfilled,
p.000004: that is, a license to conduct a clinical trial of the drug
p.000004: b) if required by the safety of the subjects or the protection of health;
p.000004: c) if the principal investigator, sub-investigators or any other person involved in the approved clinical trials does not
p.000004: meet regulatory obligations and are not governed by good clinical practice;
p.000004: d) upon the final and enforcement decision of the pharmaceutical inspector.
p.000004: (2) The Agency shall issue a decision on the suspension or prohibition of further clinical trials
p.000004: the opinion of the Commission obtained. The decision "referred to in paragraph (2) of this Article" is finally in administrative procedure.
p.000004: Article 22
p.000004: (Explanation of early completion of clinical trial and final report)
p.000004: (1) If the clinical trial of the drug is completed before the expiration of the time specified in the clinical trial protocol,
p.000004: the examiner must provide a justification for the early completion of the examination to the Agency and the professional institution where it is performed
p.000004: clinical trial.
p.000004: (2) Upon completion of the examination, a final report shall be prepared. The report "referred to in paragraph (2) of this Article", as correct
p.000004: the indicated end date of the clinical trial must be signed by the lead examiner and submitted to the Agency and the professional
p.000004: the institution where the clinical trial is being conducted.
p.000004: Article 23
p.000004: (Contents of final report)
p.000004: (1) The final report on the clinical trial of the medicinal product shall contain:
p.000004: a) general information,
p.000004: b) the protocol, phases and standard operating procedures for conducting the technical trial according to Good Clinical Practice;
p.000004: c) test results including:
p.000004: 1. clinical pharmacology (pharmacodynamics, pharmacokinetics, interactions),
p.000004: 2. bioavailability / bioequivalence,
p.000004: 3. clinical efficacy and safety,
p.000004: 4. information on the use of the medicine in countries where it is authorized.
p.000004: (2) The contents of the form for the final report on the implementation of the clinical trial of the medicinal product are laid down in Annex No. IV and
p.000004: It shall form an integral part of this Regulation.
p.000004: CHAPTER II - OBLIGATIONS OF PARTICIPANTS IN THE CLINICAL TESTING OF MEDICINES AND DOCUMENTATION
...
p.000004: be safe and properly handled.
p.000004: PART THREE - CLINICAL TESTING OF MEDICAL AGENT
p.000004: Article 33
p.000004: (Purpose of clinical trial of medical device)
p.000004: Testing of a medical device is performed to determine or confirm its effectiveness, safety and quality, in agreement
p.000004: declared use specified by the manufacturer.
p.000004: Article 34
p.000004: (Medical drug classes and clinical trial)
p.000004: (1) A clinical trial of a medical device is the determination or confirmation of the safety of a medical device,
p.000004: its effectiveness and compliance with the general and specific requirements as specified by the manufacturer.
p.000004: (2) A clinical trial shall be conducted for a Class IIa, IIb and Class III medical device, until a Class I medical device,
p.000004: except for a medical device that is sterile or that contains a radiation source.
p.000004: (3) For the clinical trial "referred to in paragraph (2) of this Article", the license shall be issued by the Agency.
p.000004: (4) The clinical trial procedure of a medical device must correspond to current scientific and technical achievements
p.000004: and principles of good clinical practice in clinical trial and medical ethics. Clinical trial results must
p.000004: capture the results of all available clinical trials of the medical device, whether positive or negative.
p.000004: (5) The documentation of the clinical trial of a medical device must include the test results that are
p.000004: detailed and objectively described and available to enable an objective assessment of the benefit-risk relationship for the patient
p.000004: an assessment of its safety, efficacy and an opinion on whether the medical device is general and specific
p.000004: the requirements of the Act and the purpose specified by the manufacturer.
p.000004: Article 35
p.000004: (Contents of clinical trial requirements for medical devices)
p.000004: (1) The following must be attached to the application for authorization to conduct a clinical trial of a medical device
p.000004: the documentation referred to in Annex number (V) which forms an integral part of this Regulation:
p.000004: a) the clinical trial plan, which contains the objectives, methods, control system, organization and statistical method
p.000004: processing;
p.000004: b) proof of insurance in the event of possible damage to the person or persons under examination or participants
p.000004: tests resulting from testing;
p.000004: c) written consent of the respondents;
p.000004: d) a report on the harmful or undesirable effects of the medical device so far (if any);
p.000004: e) an excerpt from the medical examination plan in official languages;
p.000004: f) information on the medical device: name, type, model, designation, size;
p.000004: g) documentation relating to input materials;
p.000004: h) documentation relating to the manufacturing process of the medical device;
p.000004: i) documentation relating to the final product in relation to its intended use and risk;
p.000004: j) the proposal for the labeling of the medical device and the package leaflet;
p.000004: k) documentation or confirmation of compliance with general and specific requirements;
p.000004: l) documentation of clinical trials to date (if any);
p.000004: m) a brief biography of the principal investigator;
p.000004: n) proof of payment of costs for the application and authorization of the clinical trial.
...
p.000004: Methods:
p.000004: Control system:
p.000004: Organization and method of statistical processing:
p.000004: Other goals:
p.000004: Types of testing:
p.000004: Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Respondents: Healthy volunteers Number of patients: Total number of respondents:
p.000004: Patients Total number of examinees in BiH
p.000004: One center testing
p.000004: In several centers in BiH
p.000004: International multicenter in countries:
p.000004: Length of administration of the tested medical device:
p.000004: Specify the monitoring period:
p.000004: Estimated test duration:
p.000004: Criteria for patient involvement: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including zip code):
p.000004: Name of researcher:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The examination is related to obtaining a certificate for entry in the medical registry
p.000004: funds in BiH:
p.000004: Yes no
p.000004: Clinical trial already approved in other countries: yes no Earth,
p.000004: license number, date of issue:
p.000004: ,,
p.000004: Certificate of Compliance with General and Specific Requirements
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Positive opinion of the Commission for Clinical Trials of BiH
p.000004: Proof of insurance in the event of damage to the person or persons under examination
p.000004: Respondent Information Form and Written Consent
p.000004: yes
p.000004: Proof of paid compensation
p.000004: Excerpt from medical device test plan
p.000004: Researcher's brochure / MS characteristics summary
p.000004: no
p.000004: Part / Side: from-to
p.000004: Report to date harmful or Documentation related to
p.000004: side effects MS input materials
p.000004: Documentation relating to the final product of MS regarding intent and risk
p.000004: Documentation related to the MS drafting process
p.000004: Biography of the principal investigator (s)
p.000004: Other documents
p.000004: I declare that the information given in the request and the supporting documentation is true and that no important fact exists
p.000004: may affect the safety of the test participants and the credibility of the conclusions is not hidden.
p.000004: Name, first name and title of the responsible person
p.000004: Date Signature of responsible person
p.000004: Number of pages added by the applicant due to lack of space on the form:
p.000004: Annex (VI)
p.000004: WORLD DOCTORS ASSOCIATION - DECLARATION OF HELSIN
p.000004: It contains recommendations for conducting biomedical research on humans
p.000004: It was adopted in Helsinki in June 1964. by the 18th World Medical Assembly (WMA), as amended on the 29th
p.000004: WMA meeting in October 1975 in Tokyo, the 35th WMA meeting in October 1983. in Venice, the 41st WMA meeting
p.000004: September 1989 in Hong Kong, the 48th WMA meeting in Somerset West, South Africa and the 52nd WMA meeting in Edinburgh 2000.
p.000004: Last clarification in Tokyo 2004.
p.000004: Introduction
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000004: respondents.
p.000004: 5. Each biomedical human test must be preceded by an assessment of foreseeable hazards
p.000004: giving birth with predictable benefits to the respondent or others. Respondent care must always take priority over
p.000004: interests of science and society.
p.000004: 6. The right of the respondent to protect his or her integrity must always be respected. Every precaution should be taken for
p.000004: protecting the subject and reducing the impact of the examination on his physical and mental integrity and his personality in
p.000004: as a whole.
p.000004: 7. Doctors are not allowed to undertake scientific projects on humans until they are convinced that they can be trusted
p.000004: predictability of possible risks. Doctors must stop any testing if the dangers are found to be greater than
p.000004: potential benefits.
p.000004: 8. When publishing the results of their examination, doctors are obliged to respect the accuracy of the results. Report on
p.000004: examination which does not comply with the principles of this declaration should not be accepted for publication.
p.000004: 9. In each human test, each individual respondent must be adequately informed of
p.000004: goals, methods, perceived benefit and potential testing risks as well as inconvenience
p.000004: which it may cause. The respondent should be informed of the freedom to withdraw from the examination and yes
p.000004: he comes out of questioning whenever he wants. Thereafter, the physician should be given the testimony freely given
p.000004: consent, preferably in writing.
p.000004: 10. When obtaining a test consent, the physician must be especially careful if the subject is dependent on it
p.000004: position or give consent under pressure. In this case, consent should be given to a physician who is not involved
p.000004: into the examination and which is completely independent.
p.000004: 11. If the respondent is not legally competent consent should be obtained from his legal representative in accordance with
p.000004: national legislation. Whenever a minor is in a position to give consent, it must be obtained with his consent
p.000004: legal representative.
p.000004: 12. The test plan must always include a statement of ethical elements and indicate that they are
p.000004: the principles of this declaration were respected.
p.000004: II Medical examination combined with professional supervision (clinical trial)
p.000004: 1. In treating a patient, the physician must be able to use new diagnostic and therapeutic measures, if any
p.000004: in his view, they offer hope for saving lives, restoring health and reducing suffering.
p.000004: 2. The potential benefits, dangers and inconveniences of the new method must be weighed against the benefits
p.000004: the best standard diagnostic and therapeutic methods.
p.000004: 3. In each clinical study, each patient, including one in the control group, should have, if available,
p.000004: the best, most proven diagnostic and therapeutic method available. That, in cases where there is no proven
p.000004: diagnostic or therapeutic methods, does not exclude the use of placebo.
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000004: problems in conducting a clinical trial of a drug.
p.000004: (4) During the conduct of a clinical trial of a drug, an able-bodied juvenile shall form an opinion and evaluate it
p.000004: The information he has received about participating in a clinical trial may make the decision to take any
p.000004: at the time of withdrawal or withdrawal from the clinical trial of the drug, which shall be reported to the principal investigator or member
p.000004: research team.
p.000004: (5) The applicant / client is in the process of approving a clinical trial of a medicinal product intended for children
p.000004: obliged to submit to the Commission the positive opinion of the Entity Ministries of Health / Health and the Department of Health
p.000004: Brcko District.
p.000004: Article 16
p.000004: (Specific requirements for clinical trial of an adult drug)
p.000004: (1) Clinical trial of a drug by an adult respondent who is unable to obtain legally valid informed consent
p.000004: (unconsciousness, limited physical or mental capacity, etc.), ie on adult respondent who did not refuse
p.000004: consent to participate in a clinical trial of a drug prior to the onset of its incapacity shall be subject to conditions
p.000004: prescribed by law and this regulation.
p.000004: (2) In addition to the conditions "referred to in paragraph (1) of this Article", a clinical trial of a medicinal product may also be conducted if:
p.000004: a) legal representative of an adult respondent who is unable to give legally valid informed consent in writing
p.000004: consent. The written consent of the sea represents the presumed desire of the respondent and can be withdrawn at any
p.000004: moment, without harm to him;
p.000004: b) an adult candidate who is unable to give written consent has received information to the best of his or her ability
p.000004: to understand, by a person who has experience in working with such persons, relating to the course of the clinical
p.000004: examinations, risk and health benefits of respondents;
p.000004: c) written consent given without prompting him to participate in the clinical trial of the drug or offering it either
p.000004: what material or other uses;
p.000004: d) it is estimated that a clinical trial of the medicinal product on that face provides direct benefit to a group of patients whose
p.000004: illness or condition corresponds to illness or condition of the subjects;
...
General/Other / Other Country
Searching for indicator another country:
(return to top)
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: the drug in question contains more active substances: yes
p.000004: Type of medicine:
p.000004: no Specify total number:
p.000004: Radiopharmaceutical drug
p.000004: Drug containing synthetic active substance Herbal drug
p.000004: A drug for dental use
p.000004: A drug containing a narcotic or psychotropic substance
p.000004: Other medicines intended for use in testing
p.000004: Name of the drug, form (s), strength (s):
p.000004: Immunological Drug Blood Derivative Biotechnological Drug Others Specify:
p.000004: Yes no
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: no yes License number:
p.000004: Holder of Marketing Authorization (name, address):
p.000004: The procedure for issuing a license in BiH is to:
p.000004: no
p.000004: Number of requests:
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: The medicine is registered in another country:
p.000004: Expiration date:
p.000004: Method of administration:
p.000004: yes Study number and date
p.000004: no license:
p.000004: yes Earth, year and number
p.000004: do not allow: Storage conditions:
p.000004: Dosage in clinical trial:
p.000004: Active substance (s), name (for radiopharmaceuticals - radionuclide)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000004: described in the clinical trial protocol.
p.000004: (3) The proposer of the test shall supply the examiner with the drug when he has obtained the necessary clinical trial permit from
p.000004: Import Agencies and Consents by the Entity Ministries of Health.
p.000004: (4) The proponent of the test shall, when delivering the medicines "referred to in paragraph (3) of this Article," submit it to the examiner
p.000004: and written instructions on how to handle and store these medicines, as well as instructions on how to handle what they will after the test
p.000004: possibly remaining unused.
p.000004: (5) The proponent of the examination shall be obliged to draw up the delivery of medicines as well as the written instructions "from paragraph (4) of this Article"
p.000004: a written statement.
p.000004: (6) The test proponent must ensure the stability of the investigational medicinal product as well as its regular supply
p.000004: throughout the examination.
p.000004: (7) The proponent of the test shall be obliged to describe in detail the manner in which the investigational medicinal product will be labeled,
p.000004: deliver, distribute and store.
p.000004: (8) The notes must contain information on the transport, shipment, receipt, distribution, return and destruction of each
p.000004: of the remaining drug. The examiner must not administer the medication being tested to any person not designated to receive it.
p.000004: (9) The test proponent shall be responsible for the proper packaging and labeling of the investigational medicinal products. The mark must
p.000004: indicate that the product is for clinical trial use only.
p.000004: (10) In blind tests, the packaging must be labeled in such a way as to prevent identification. U
p.000004: emergency situations must be able to determine the identity of current treatment received by a particular respondent.
p.000004: (11) In blind studies, the drug to be tested, including the control drug and placebo, must be of equal value.
p.000004: appearance, taste, smell and other physical characteristics.
p.000004: (12) It is the responsibility of the test proponent to ensure that the packaging of the investigational medicinal product is of appropriate dimensions for
p.000004: testing and appropriate for the respondents and is required to provide sufficient samples of each batch used for the sake of
p.000004: needs for re-analysis and control in the future.
p.000004: (13) Should the formulation of the control drug change, the need for comparative in vivo biological consideration should be considered
p.000004: tests and test dissolution or other in vitro tests.
p.000004: Article 26
p.000004: (Clinical Trial Observer)
p.000004: (1) The competent observer shall be determined by the contracting authority with the consent of the examiner. The number of competent observers depends on
p.000004: the complexity of drug testing and the number of participating centers. The competent observer must be available to the examiner.
p.000004: (2) The primary obligation of the competent observer is to supervise the conduct of the test and to ensure that it is conducted in accordance with that
p.000004: test protocol.
p.000004: (3) Any unjustified deviation from the test protocol and any violation of Good Clinical Practice by a competent observer
...
p.000004: examiners and examiners.
p.000004: Article 31
p.000004: (Examiner's obligations)
p.000004: (1) The examiner shall be responsible for strictly implementing the clinical trial protocol as follows:
p.000004: a) The examiner may not make any changes to the approved test except in the case of a direct procedure if necessary
p.000004: to eliminate the obvious imminent risk or danger to the respondents by obligatory notifying the Agency thereof;
p.000004: b) in the case of annexes to the clinical trial protocol, the prior approval of the Commission shall be obtained;
p.000004: c) the form of the annexes to the protocol related to the conduct of the clinical trial of the medicinal product has the prescribed contents in Annex no.
p.000004: (III) and is an integral part of this Regulation;
p.000004: d) the examiner must provide appropriate information to the subjects in the clinical trial and comply with the provisions
p.000004: The Declaration of Helsinki and the International Ethical Guidelines for Human Biomedical Testing;
p.000004: e) The nature of the information to be communicated to the subjects depends on the complexity of the clinical trial and the type of drug
p.000004: being examined;
p.000004: f) the information "referred to in point e) of this paragraph" shall, as a rule, be given both verbally and in writing and in a language which is
p.000004: understandable to the respondent;
p.000004: g) the examiner is obliged to inform the subjects about their participation in the clinical trial, to mark the persons from whom
p.000004: may request assistance in an emergency, and alert to the need to keep the said information with them;
p.000004: h) the examiner must be aware of the properties and effects, including information obtained prior to the clinical trial, o
p.000004: the product being tested clinically;
p.000004: i) the examiner must be aware of all relevant new product information that appears during the clinical course
p.000004: testing;
p.000004: j) in the case of a serious undesirable effect, the examiner must inform the proposer of the test without delay,
p.000004: the professional institution where the clinical trial is conducted and through the applicant the Agency;
p.000004: k) the examiner must be available at periodic visits by the competent observer and during the supervision
p.000004: the pharmaceutical inspector as well as the persons designated by the test proponent for quality assurance.
p.000004: (2) The examiner must ensure that:
p.000004: a) safe treatment with the medicinal product being tested during and after the test;
p.000004: b) that the investigational medicinal product is used only in accordance with the clinical trial protocol and is being tested
p.000004: include respondents who are responsible to the examiner;
p.000004: c) the dose and instructions for use are appropriate and understood by each subject;
p.000004: d) that the unused drug under test be returned or destroyed and the notes made on it
p.000004: keep activities according to the test protocol.
p.000004: Article 32
p.000004: (Obligations of the contracting authority)
p.000004: (1) The contracting authority shall be responsible for the implementation of the quality assurance system with regard to site verification
p.000004: the conduct of the examination, all data and records relating thereto.
...
p.000004: 7. Description of the respondents. Criteria for inclusion and non-inclusion of potential respondents and how they are collected,
p.000004: types, methods and time of assignment of respondents. Exclusion criteria for previously included respondents;
p.000004: 8. Number of respondents required to achieve the objective of the examination based on statistical considerations;
p.000004: 9. Description and justification of the route of administration, the dose, the interval between doses and the period of administration of the investigational medicinal product and that
p.000004: used as a control;
p.000004: 10. Any other treatment that may or may be used at the same time as the treatment
p.000004: testing;
p.000004: 11. Clinical and laboratory tests during the course of pharmacokinetic analysis and others which are approved during the study
p.000004: plan (protocol) tests must be carried out;
p.000004: 12. Description of how the reactions to the administration of the drug will be recorded. Description and evaluation of measurement methods, measurement time, method
p.000004: monitoring;
p.000004: 13. Instructions for completing the whole or part of the test;
p.000004: 14. Methods of registering and reporting adverse events, adverse reactions and adverse events. Procedure
p.000004: in case of complications;
p.000004: 15. Method of archiving the list of subjects with the codes of the subjects, data on the use of the drug, the list of randomization and / or the test list.
p.000004: The records must allow for easy identification of individual respondents or participants as well as surveillance data and
p.000004: reconstruction (data);
p.000004: 16. Information on the test code of where it will be archived and when, how and by whom in case of emergency
p.000004: open;
p.000004: 17. Measures to be taken to ensure the safe handling and storage of pharmaceutical products and measures to ensure
p.000004: encourage and control adherence to all clinical trial guidelines;
p.000004: 18. Description of methodology and evaluation of results (eg statistical methods) as well as description of patients / participants who have dropped out
p.000004: testing
p.000004: 19. Time until completion of examination;
p.000004: 20. Information to be provided to the respondents including information on how they will be notified of the examination and how and where
p.000004: will give consent;
p.000004: 21. Instructions for persons, e.g. how the persons will be informed of the manner in which the examination will be conducted and its application;
p.000004: 22. Definition of medical care for the subjects after the examination including the method of treatment;
p.000004: 23. Data on financing, insurance, liability and transfer / distribution of responsibilities;
p.000004: 24. List of references referred to in the test plan.
p.000004: Annex (III)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Medicines Agency of Bosnia and Herzegovina
p.000004: APPLICATION FOR AUTHORIZATION FOR AMENDMENT OF THE CLINICAL TEST
p.000004: Amendments to the clinical trial plan (protocol) Amendments to the original clinical trial request
p.000004: Test Name:
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000004: presents a detailed description of the test after completion and includes a description of the test methodology, method
p.000004: statistical data processing, description of respondents, presentation and evaluation of statistical analysis results, and critical, ethical,
p.000004: statistical and clinical evaluation of the whole trial;
p.000004: q) Quality control means operational techniques and activities undertaken within the assurance system
p.000004: quality, in order to confirm that all the quality requirements have been met;
p.000004: r) Good manufacturing practice is part of a quality assurance system that ensures that medicines are consistently and
p.000004: continuously produce and control according to appropriate quality standards in accordance with their purpose;
p.000004: s) Multicenter clinical trial is a clinical trial conducted according to a single protocol
p.000004: a multi-center clinical trial run by multiple examiners, with the centers where the tests are being conducted
p.000004: may be located in one or more countries;
p.000004: t) Surveillance is a systematic test conducted (as a rule on a randomly selected sample of data) by a trained person.
p.000004: which does not directly participate in the trial in order to determine whether the clinical trial in question is being conducted according to
p.000004: approved plan
p.000004: trials, in accordance with standard operating procedures and Good Clinical Practice. It is monitored by the monitor it has
p.000004: appropriate qualifications to perform clinical trial monitor jobs and have good clinical education
p.000004: practice;
p.000004: u) Competent observer is a qualified person who independently assesses the conformity of all on behalf of the contracting authority
p.000004: activities related to clinical trial, protocol, standard operating procedures, Good
p.000004: clinical practice and with applicable regulations;
p.000004: v) The client of the trial is the legal entity at whose request the clinical trial is conducted;
p.000004: w) Adverse drug action is any adverse and unintentionally triggered reaction that may occur during a therapeutic
p.000004: dose of the drug. A side effect of a drug can also be defined as any adverse reaction to a drug that has been administered
p.000004: at the usual dose for prophylactic, diagnostic or therapeutic purposes, or for modifying physiological functions, with
p.000004: the condition that there is a cause and effect relationship, or that relationship cannot be ruled out;
p.000004: x) Adverse drug reaction in a clinical trial is an undesirable and unintentionally induced reaction in a subject,
p.000004: which may occur in a clinical trial of a drug in connection with any dose of the drug;
p.000004: y) An unexpected side effect of a drug is one that has an unknown nature, severity or outcome,
p.000004: that is, they are not described in the Summary of Product Characteristics and Package Leaflet, or are not part of this effect
p.000004: current knowledge of the drug;
p.000004: z) Adverse event in clinical trial is an unwanted experience (any adverse and undesirable sign such as
...
p.000004: (1) The clinical trial shall determine: the efficacy of the drug, the relationship between the beneficial and adverse effects of the drug,
p.000004: side effects, bioequivalence and bioavailability;
p.000004: (2) All clinical trials of medicinal products on humans must be conducted in accordance with the ethical principles laid down in Helsinki
p.000004: the Patient Rights Protection Declaration (hereinafter: the Declaration of Helsinki) and in accordance with the rules of good clinical
p.000004: practices and this Rulebook;
p.000004: (3) The medicinal product may be clinically tested after having received a positive evaluation of the pharmaceutical-chemical-biological and pharmacological-
p.000004: toxicological study of the drug.
p.000004: Article 5
p.000004: (Investigator)
p.000004: (1) Clinical trials shall be performed at the request of the client of the trial: the manufacturer, that is, legal or natural persons
p.000004: which acts on behalf of the manufacturer and is established in Bosnia and Herzegovina, interested legal persons, individuals, or at
p.000004: the request of the competent ministry;
p.000004: (2) The test client is responsible for the reliability of the data and information made available to the examiner
p.000004: before the start of the clinical trial, or those that occur during the trial;
p.000004: (3) The investigator and the examiner are obliged to cooperate with the authorized institution where the clinical
p.000004: testing regarding reporting, implementation of changes to clinical trial protocols, reporting adverse events, and
p.000004: submission of test reports;
p.000004: (4) The contracting authority shall organize a quality assurance system (including independent supervision) for implementation
p.000004: testing;
p.000004: (5) The contracting authority shall prepare written detailed standard operating procedures (SOPs), in accordance with Good
p.000004: clinical practice;
p.000004: (6) The investigator and the examiner must agree and sign the clinical trial protocol, and
p.000004: determine the method of data entry.
p.000004: Article 6
p.000004: (Authorization for clinical trial of a medicinal product)
p.000004: (1) Each clinical trial of a medicinal product must be approved by the Agency for Medicinal Products and Medical Devices of Bosnia
p.000004: and Herzegovina (hereinafter: the Agency);
p.000004: (2) Prior to granting a license to conduct a clinical trial of a medicinal product "referred to in paragraph (2) of this Article"
p.000004: obtain the approval of the Clinical Trials Committee for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: (the Commission);
p.000004: (3) The Agency is obliged to issue a clinical trial authorization within 60 days from the date of admission
p.000004: a formal request, based on the Commission's opinion.
p.000004: Article 7
p.000004: (Costs of clinical trial of the drug)
p.000004: (1) The costs of applying for a clinical trial and licensing shall be borne by the applicant for the trial;
p.000004: (2) The amount of compensation for the work of the members of the Commission shall be determined by a decision of the Agency and shall be borne by the proposer
p.000004: testing.
p.000004: Article 8
p.000004: (Contents of request for clinical trial of drug)
p.000004: The following shall be attached to the application for authorization to conduct a clinical trial of a medicinal product and a medical device
p.000004: documentation:
p.000004: a) a cover letter with a mandatory list of documents with the date and signature of the applicant;
...
p.000004: who are allowed to open the code and name of the person authorized to do so. It is necessary to provide a system, which will
p.000004: in case of urgency, provide access to information about the treatment of the individual respondent. The system must allow access
p.000004: treatment of only one subject at a time. If the code is open, the same should be justified and documented in
p.000004: test lists of respondents;
p.000004: c) the types of statistical analysis must be specified in the clinical trial protocol and any deviation from
p.000004: the clinical trial protocol must be described and justified in the final trial report. Planned Analysis i
p.000004: its implementation must be carried out or confirmed and identified by an educated statistician. Options or
p.000004: the circumstances of the inter-assay during the trial must also be specified in the clinical trial protocol.
p.000004: The examiner and the authorized observer must ensure that the data is of the highest quality possible at the stage of their own
p.000004: collection, and the statistician must ensure uniformity of data during processing. The results of the analyzes must be presented
p.000004: in such a way that they allow the interpretation of clinical relevance by assessing the magnitude of the difference in treatment effect and interval
p.000004: reliability is more than just testing for statistical significance. An estimate of the data omitted from
p.000004: statistical analysis. All such exclusions must be documented so that they can be repeated if necessary
p.000004: analysis.
p.000004: (2) The clinical trial should be conducted in accordance with the clinical trial protocol agreed and signed by
p.000004: the contracting authority and the examiner.
p.000004: (3) The contracting authority and the examiner must agree on any change that occurs during the examination,
p.000004: sign it and add it in addition to the clinical trial protocol (amendment).
p.000004: (4) The clinical trial protocol must describe the objectives of the trial, the procedures to be followed,
p.000004: the reasons why the test is conducted on humans, the nature and degree of any known risk, the groups from which they will
p.000004: Respondents are also selected ways to ensure adequate information before respondent agrees
p.000004: participates in the examination.
p.000004: (5) The model of the protocol for conducting the clinical trial has the prescribed content in Annex number (II) and its constituent
p.000004: is part of this Ordinance.
p.000004: Article 12
p.000004: (Contents of Instructions for Examiner)
p.000004: (1) The Examiner Instruction is a brief overview of existing clinical and pre-clinical trial data on a
p.000004: examines in a clinical trial.
p.000004: (2) The proponent of the study must regularly obtain new knowledge of the medicinal product obtained during the clinical trial
p.000004: provide the examiner with supplemental instructions.
p.000004: (3) The examiner's instruction shall contain:
p.000004: a) the content of the clinical trial,
p.000004: b) the content of the clinical trial,
p.000004: c) introductory remarks,
p.000004: d) the physical, chemical and pharmaceutical properties of the pharmaceutical formulation and formulation,
p.000004: e) preclinical studies (preclinical pharmacology, pharmacokinetics and drug metabolism in animals; and
p.000004: toxicology);
p.000004: f) the effect of the test drug in humans (Pharmacokinetics, drug metabolism in humans, tolerability, effects,
...
p.000004: of the remaining drug. The examiner must not administer the medication being tested to any person not designated to receive it.
p.000004: (9) The test proponent shall be responsible for the proper packaging and labeling of the investigational medicinal products. The mark must
p.000004: indicate that the product is for clinical trial use only.
p.000004: (10) In blind tests, the packaging must be labeled in such a way as to prevent identification. U
p.000004: emergency situations must be able to determine the identity of current treatment received by a particular respondent.
p.000004: (11) In blind studies, the drug to be tested, including the control drug and placebo, must be of equal value.
p.000004: appearance, taste, smell and other physical characteristics.
p.000004: (12) It is the responsibility of the test proponent to ensure that the packaging of the investigational medicinal product is of appropriate dimensions for
p.000004: testing and appropriate for the respondents and is required to provide sufficient samples of each batch used for the sake of
p.000004: needs for re-analysis and control in the future.
p.000004: (13) Should the formulation of the control drug change, the need for comparative in vivo biological consideration should be considered
p.000004: tests and test dissolution or other in vitro tests.
p.000004: Article 26
p.000004: (Clinical Trial Observer)
p.000004: (1) The competent observer shall be determined by the contracting authority with the consent of the examiner. The number of competent observers depends on
p.000004: the complexity of drug testing and the number of participating centers. The competent observer must be available to the examiner.
p.000004: (2) The primary obligation of the competent observer is to supervise the conduct of the test and to ensure that it is conducted in accordance with that
p.000004: test protocol.
p.000004: (3) Any unjustified deviation from the test protocol and any violation of Good Clinical Practice by a competent observer
p.000004: must, without delay, inform the investigator, the Agency and the professional institution where the clinical is performed
p.000004: examination.
p.000004: Article 27
p.000004: (Special Obligations of Clinical Trial Observer)
p.000004: (1) In addition to the basic obligation "referred to in Article 26 of this Ordinance", the competent observer shall also have the obligation:
p.000004: a) supervise the implementation of the test protocol and ensure that all test data is kept orderly and complete
p.000004: recorded;
p.000004: b) determine whether adequate space, personnel and equipment, laboratories,
p.000004: and assess the availability of an adequate number of subjects during the examination;
p.000004: c) ensure that staff assisting the examiner in the examination are informed of the examination and that all details are respected
p.000004: testing;
p.000004: d) ensure liaison between the examiner and the proposer of the test during the conduct of the test;
p.000004: e) ensure that the test lists of respondents are filled in correctly;
p.000004: f) examine whether the supplies, distribution and refund of the investigational medicinal product have been secured and documented at
p.000004: appropriate manner in accordance with regulations;
...
p.000004: b) that there is information on the quantities of the drug being tested;
p.000004: b.
p.000004: c) storage conditions of the investigational medicinal product;
p.000004: d) treatment with returned or unused drug.
p.000004: Article 28
p.000004: (Side effects, side effects and adverse events during clinical trial of the drug)
p.000004: (1) The occurrence of any undesirable effect, adverse reaction or adverse event of a did drug must be taken carefully
p.000004: monitor and record in detail throughout the examination.
p.000004: (2) The clinical trial protocol shall specify the method by which adverse reactions, adverse reactions or
p.000004: adverse events "referred to in paragraph (1) of this Article".
p.000004: (3) The investigator shall make available to the Agency questionnaires for reporting adverse reactions.
p.000004: (4) The client must report all adverse reactions to the Agency and the ethical committee of the institution where the clinical is performed.
p.000004: examination.
p.000004: (5) The reports "referred to in paragraph (4) of this Article” must contain evaluations of causation and possible impact on the
p.000004: examination and future use of the product being tested, as well as the identification of the subjects and methods of testing.
p.000004: (6) Upon completion of the study, any recorded adverse reactions of did drug or medical devices must be determined
p.000004: and evaluated in the final report.
p.000004: (7) The contracting authority shall, without delay, inform the examiner of any trial of the same medicinal product, anywhere
p.000004: and discontinued at any time, as well as withdrawal of that medicine for lack of safety.
p.000004: Article 29
p.000004: (Notes and information during the clinical trial of the medicine)
p.000004: (1) The purpose of keeping notes in the drug test procedure is to register information, transfer information,
p.000004: effective and proper modification of information obtained from respondents into data that can be used in the report.Svi
p.000004: test procedures must be documented.
p.000004: (2) The basic feature of the uniqueness of the data is to ensure a "blind" test with respect to species determination
p.000004: treatment, which begins with the randomization of subjects into different groups and is maintained throughout the data processing
p.000004: until the decision to open the code is made.
p.000004: (3) In the case of electronic data processing, the confidentiality of the database must be specifically ensured as well as its accuracy.
p.000004: Article 30
p.000004: (Method and time limit for keeping clinical trial records)
p.000004: (1) The contracting authority shall ensure that the respondents' identification codes are archived for security reasons and
p.000004: efficiency.
p.000004: (2) The contracting authority shall take appropriate measures to keep the other documentation relating to
p.000004: examination.
p.000004: (3) The information "referred to in paragraph (2) of this Article" may be stored on a microfilm or electronically, provided that there is a copy on
p.000004: paper.
p.000004: (4) The trial contracting authority must keep the clinical trial protocol, documentation, permit and all other documents
p.000004: concerning the tests, including certificates on how to perform the procedures 5 years after the end of the clinical trials,
p.000004: that is, even after the said deadline, if other applicable criteria or agreements between the contracting authorities so require
p.000004: examiners and examiners.
p.000004: Article 31
p.000004: (Examiner's obligations)
p.000004: (1) The examiner shall be responsible for strictly implementing the clinical trial protocol as follows:
p.000004: a) The examiner may not make any changes to the approved test except in the case of a direct procedure if necessary
p.000004: to eliminate the obvious imminent risk or danger to the respondents by obligatory notifying the Agency thereof;
p.000004: b) in the case of annexes to the clinical trial protocol, the prior approval of the Commission shall be obtained;
p.000004: c) the form of the annexes to the protocol related to the conduct of the clinical trial of the medicinal product has the prescribed contents in Annex no.
p.000004: (III) and is an integral part of this Regulation;
p.000004: d) the examiner must provide appropriate information to the subjects in the clinical trial and comply with the provisions
p.000004: The Declaration of Helsinki and the International Ethical Guidelines for Human Biomedical Testing;
p.000004: e) The nature of the information to be communicated to the subjects depends on the complexity of the clinical trial and the type of drug
p.000004: being examined;
p.000004: f) the information "referred to in point e) of this paragraph" shall, as a rule, be given both verbally and in writing and in a language which is
p.000004: understandable to the respondent;
p.000004: g) the examiner is obliged to inform the subjects about their participation in the clinical trial, to mark the persons from whom
p.000004: may request assistance in an emergency, and alert to the need to keep the said information with them;
p.000004: h) the examiner must be aware of the properties and effects, including information obtained prior to the clinical trial, o
p.000004: the product being tested clinically;
p.000004: i) the examiner must be aware of all relevant new product information that appears during the clinical course
p.000004: testing;
p.000004: j) in the case of a serious undesirable effect, the examiner must inform the proposer of the test without delay,
p.000004: the professional institution where the clinical trial is conducted and through the applicant the Agency;
p.000004: k) the examiner must be available at periodic visits by the competent observer and during the supervision
p.000004: the pharmaceutical inspector as well as the persons designated by the test proponent for quality assurance.
p.000004: (2) The examiner must ensure that:
p.000004: a) safe treatment with the medicinal product being tested during and after the test;
p.000004: b) that the investigational medicinal product is used only in accordance with the clinical trial protocol and is being tested
p.000004: include respondents who are responsible to the examiner;
p.000004: c) the dose and instructions for use are appropriate and understood by each subject;
p.000004: d) that the unused drug under test be returned or destroyed and the notes made on it
p.000004: keep activities according to the test protocol.
p.000004: Article 32
p.000004: (Obligations of the contracting authority)
p.000004: (1) The contracting authority shall be responsible for the implementation of the quality assurance system with regard to site verification
p.000004: the conduct of the examination, all data and records relating thereto.
p.000004: (2) All observations and findings must be available for verification to ensure the credibility of all information, and that
p.000004: the conclusions drawn from the processing of the raw data obtained are correct.
p.000004: (3) Verification procedures must be justified and specified.
p.000004: (4) Sampling should be controlled by a statistically acceptable method of verification in testing.
p.000004: (5) Quality control must be applied at every stage of data processing, to ensure that all data
p.000004: be safe and properly handled.
p.000004: PART THREE - CLINICAL TESTING OF MEDICAL AGENT
p.000004: Article 33
p.000004: (Purpose of clinical trial of medical device)
p.000004: Testing of a medical device is performed to determine or confirm its effectiveness, safety and quality, in agreement
p.000004: declared use specified by the manufacturer.
p.000004: Article 34
p.000004: (Medical drug classes and clinical trial)
p.000004: (1) A clinical trial of a medical device is the determination or confirmation of the safety of a medical device,
p.000004: its effectiveness and compliance with the general and specific requirements as specified by the manufacturer.
p.000004: (2) A clinical trial shall be conducted for a Class IIa, IIb and Class III medical device, until a Class I medical device,
p.000004: except for a medical device that is sterile or that contains a radiation source.
p.000004: (3) For the clinical trial "referred to in paragraph (2) of this Article", the license shall be issued by the Agency.
p.000004: (4) The clinical trial procedure of a medical device must correspond to current scientific and technical achievements
...
p.000004: ("Official Gazette of the Federation of Bosnia and Herzegovina", No. 61/04), Rulebook on Amendments to the Rulebook on Good Clinical Practice
p.000004: and clinical trials of the medicinal product (Official Gazette of the Federation of Bosnia and Herzegovina, No. 56/05), Rulebook on Clinical
p.000004: drug testing ("Official Gazette of the Republika Srpska", no. 64/05) and Rulebook on Amendments to the Rulebook on
p.000004: clinical trial of the medicinal product (Official Gazette of the Republika Srpska, No. 23/07).
p.000004: Article 42
p.000004: (Entry into Force and Publication)
p.000004: This Rulebook shall enter into force on the day of its adoption and shall be published in the Official Gazette of BiH.
p.000004: No. 08-02-2-1172-2-JD / 09
p.000004: December 10, 2009
p.000004: Minister
p.000004: Mr. Sredoje Novic, s. r.
p.000004: Annex (1)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Medicines Agency of Bosnia and Herzegovina
p.000004: APPLICATION FOR A CLINICAL TESTING AUTHORIZATION / CLINICAL TEST APPLICATION
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: test proponent Test drug, name, form (s) of drug, strength (s)
p.000004: contract research organization
p.000004: examiner
p.000004: Drug manufacturer (name, address):
p.000004: Medication registered in BiH: yes License number:
p.000004: no
p.000004: Marketing Authorization Holder (name, address):
p.000004: The approval procedure in Bosnia and Herzegovina is ongoing: yes
p.000004: Number of requests: no
p.000004: The drug has been tested in Bosnia and Herzegovina:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: licensing: no
p.000004: Country, year and approval number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration: Dosage in clinical trial: Active substance (s), name
p.000004: (for radiopharmaceuticals - radionuclide):
p.000004: Substance contained in a drug already registered in the world: no
p.000004: yes Countries where it is registered and year of registration:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: the drug in question contains more active substances: yes
p.000004: Type of medicine:
p.000004: no Specify total number:
...
p.000004: testing
p.000004: 19. Time until completion of examination;
p.000004: 20. Information to be provided to the respondents including information on how they will be notified of the examination and how and where
p.000004: will give consent;
p.000004: 21. Instructions for persons, e.g. how the persons will be informed of the manner in which the examination will be conducted and its application;
p.000004: 22. Definition of medical care for the subjects after the examination including the method of treatment;
p.000004: 23. Data on financing, insurance, liability and transfer / distribution of responsibilities;
p.000004: 24. List of references referred to in the test plan.
p.000004: Annex (III)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Medicines Agency of Bosnia and Herzegovina
p.000004: APPLICATION FOR AUTHORIZATION FOR AMENDMENT OF THE CLINICAL TEST
p.000004: Amendments to the clinical trial plan (protocol) Amendments to the original clinical trial request
p.000004: Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the proponent of the examination to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: trial proponent Type of clinical trial modification
p.000004: contract research organization
p.000004: examiner
p.000004: These amendments mainly relate to the precautionary measures already in place that do not
p.000004: clinical trial amendments:
p.000004: Changes made in the safety and integrity of the respondents yes
p.000004: no Changes made in the interpretation of the professional documentation / test results yes no
p.000004: Changes made in the quality of the investigated medical product yes no
p.000004: Changes in the management or management of the clinical trial:
p.000004: Amendments or inclusion of additional examination site, change of principal examiner yes no
p.000004: Changes to the trial client, legal representative, applicant for the clinical trial
p.000004: Yes no
p.000004: Changes in the Transfer of Major Assignments and Obligations in the Clinical Trial Not to Specify:
p.000004: Other changes
p.000004: Yes no
p.000004: Specify:
p.000004: Second:
p.000004: Yes no
p.000004: Specify:
p.000004: Content of clinical trial amendments:
p.000004: Amendments to the information provided in the clinical trial request yes no
p.000004: additions to the clinical trial plan (protocol) yes no
p.000004: Amendments to other documents
p.000004: Yes no
p.000004: Specify:
p.000004: Second:
p.000004: Yes no
p.000004: Specify:
p.000004: Reasons for amendments:
p.000004: Short description of the amendments:
p.000004: Submitted documentation Part / page:
p.000004: from to
p.000004: Proof of Paid List of Changed Documents
p.000004: Part / Side: from-to
p.000004: Review proposed changes
p.000004: Other documents
p.000004: Supporting documentation
p.000004: I declare that the information in the request and the supporting documentation is true and that no important fact that may affect
p.000004: the safety of the participants in the examination and the credibility of the conclusions are not hidden.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
p.000004: Annex (IV)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Medicines Agency of Bosnia and Herzegovina
p.000004: CLINICAL TEST COMPLETION NOTICE
p.000004: Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Proposer (name, address):
p.000004: Applicant, authorized by the proponent of the examination to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: proponent of the examination
p.000004: Completion of examination
p.000004: contract research organization
p.000004: examiner
p.000004: Completion of examination in Bosnia and Herzegovina yes no Date:. . .year.
p.000004: Completion of testing in all countries where the test was conducted
p.000004: yes
p.000004: no Date:. . .year.
p.000004: Premature examination completed yes
p.000004: Suspension yes
p.000004: Reason for provisionally ending the test:
p.000004: Security yes
p.000004: Inefficiency yes
p.000004: Testing not started yes
p.000004: Second yes
p.000004: no Date:. . .year.
p.000004: no Date:. . .year.
p.000004: no no no no
p.000004: Specify:
p.000004: Number of subjects still receiving therapy at the time of discontinuation or suspension of a clinical trial at
p.000004: Bosnia and Herzegovina
p.000004: In case of interruption of the clinical trial or its early termination, briefly describe in the Appendix:
p.000004: - justification for termination or early termination of the examination
p.000004: - the proposed treatment of subjects receiving therapy at the time of early termination or suspension
p.000004: - the consequences of prematurely discontinuing the trial to evaluate the results and analyze the benefit-risk balance of the test drug
p.000004: I declare that the information given in the notice is correct and that clinical trial reports will be submitted
p.000004: The Agency and the responsible ethics committee within 90 days of the completion of the examination in all countries in which it was conducted
p.000004: examination.
p.000004: Name and surname of the responsible person
p.000004: Date Signature of responsible person
p.000004: Annex (V)
p.000004: Medicines Agency of Bosnia and Herzegovina
p.000004: Address: Veljka Mlađenovića b.b. ; 78000 Banja Luka, Bosnia and Herzegovina, Phones: +387 (0) 51 456040; +387 (0) 51 456050
p.000004: Fax +387 (0) 51 450301; E-mail: klinicka@alims.gov.ba
p.000004: Number: Received by:
p.000004: Date of receipt:
p.000004: Request date with additional documentation:
p.000004: Date of receipt of additional documentation:
p.000004: Date when the request is formally complete:
p.000004: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000004: APPLICATION FOR A CLINICAL TESTING OF A MEDICAL MEDICINE / APPLICATION OF A CLINICAL TEST
p.000004: Request for Clinical Trial Authorization Application for Clinical Trial Test Name:
p.000004: Clinical trial plan (protocol) number, including number of amendments, if required:
p.000004: Investigator (name, address):
p.000004: Applicant, authorized by the contracting authority to cooperate with the Agency during the examination, if not
p.000004: ordering authority (name, address):
p.000004: Contact address (name, address, telephone, fax, e-mail):
p.000004: Applicant: Investigator
p.000004: contract research organization
p.000004: examiner
p.000004: Tested medical device, name, form (s) of medical device, packaging (s)
p.000004: Manufacturer of medical device (name, address):
p.000004: Medical device registered in BiH: yes Certificate number:
p.000004: no
p.000004: Holder of certificate for registration of the register of medical devices (name, address):
p.000004: The procedure for certification in Bosnia and Herzegovina is underway:
p.000004: yes Number of requests: no
p.000004: The medical device has been tested in BiH:
p.000004: Registered in other countries
p.000004: Study number and date
p.000004: yes licensing: no
p.000004: Country, year and certificate number:
p.000004: Yes no
p.000004: Shelf life: Storage conditions:
p.000004: Method of administration of medical device:
p.000004: Active substance (s), name (for medicinal products containing the medicinal product or medicinal substances):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: Countries where the medical device is registered and year of registration:
p.000004: no yes
p.000004: the medicinal product being tested contains more active substances:
p.000004: Type of medical device:
p.000004: Class I Class IIa Class IIb Class III
p.000004: In vitro diagnostic medical devices
p.000004: Medical Information:
p.000004: Name, type, model:
p.000004: Label, size, packaging:
p.000004: Proposal for the labeling of the medical device and instructions for use:
p.000004: Clinical trial plan:
p.000004: Yes no
p.000004: Specify the total number:
p.000004: Main objective of the test:
p.000004: Methods:
p.000004: Control system:
...
General/Other / participants in a control group
Searching for indicator control group:
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p.000004: consent, preferably in writing.
p.000004: 10. When obtaining a test consent, the physician must be especially careful if the subject is dependent on it
p.000004: position or give consent under pressure. In this case, consent should be given to a physician who is not involved
p.000004: into the examination and which is completely independent.
p.000004: 11. If the respondent is not legally competent consent should be obtained from his legal representative in accordance with
p.000004: national legislation. Whenever a minor is in a position to give consent, it must be obtained with his consent
p.000004: legal representative.
p.000004: 12. The test plan must always include a statement of ethical elements and indicate that they are
p.000004: the principles of this declaration were respected.
p.000004: II Medical examination combined with professional supervision (clinical trial)
p.000004: 1. In treating a patient, the physician must be able to use new diagnostic and therapeutic measures, if any
p.000004: in his view, they offer hope for saving lives, restoring health and reducing suffering.
p.000004: 2. The potential benefits, dangers and inconveniences of the new method must be weighed against the benefits
p.000004: the best standard diagnostic and therapeutic methods.
p.000004: 3. In each clinical study, each patient, including one in the control group, should have, if available,
p.000004: the best, most proven diagnostic and therapeutic method available. That, in cases where there is no proven
p.000004: diagnostic or therapeutic methods, does not exclude the use of placebo.
p.000004: 4. A patient's refusal to participate in the examination should never affect his or her relationship with the physician.
p.000004: 5. If the doctor deems it necessary not to obtain consent, the specific reasons for this must be stated in the plan
p.000004: (protocol) tests, to be submitted to an independent representative.
p.000004: 6. The physician may combine medical examination with professional supervision in order to acquire new medical knowledge
p.000004: only to the extent that the test is justified in terms of its potential diagnostic or therapeutic
p.000004: values for the patient.
p.000004: III Non-therapeutic biomedical testing in humans (non-clinical biomedical testing)
p.000004: 1. In the purely scientific application of medical examination to humans, it is the duty of the physician to remain a protector
p.000004: the life and health of the person to be tested.
p.000004: 2. The subject must be a volunteer, healthy or ill, for whom the type of examination is not related to his or her own
p.000004: disease.
p.000004: 3. The examiner or examination team must suspend the tests if it concludes that further testing may be detrimental
p.000004: to the respondent.
p.000004: 4. In human inquiry, the interest of science and society can never be more important than the welfare of the respondents.
p.000004: 2004 Audits
...
Searching for indicator placebo:
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p.000004: c) Pharmacogenomics is a study of variations in DNA and RNA characteristics related to a given drug response;
p.000004: d) Pharmacogenetics is a branch of pharmacogenomics and is defined as a study of variations in DNA strand sequences related to
p.000004: drug response;
p.000004: e) Pharmacodynamics is the study of the interaction between a drug and its molecular targets;
p.000004: f) Genes are functional segments of genetic material that serve as a schematic blueprint for protein synthesis;
p.000004: g) A genome is the total genetic material of an organism;
p.000004: h) The Institutional Ethics Committee is an independent, advisory body whose duty is to evaluate the justification
p.000004: clinical trial, as well as the possibility of conducting a clinical trial according to the principles of Good Clinical Practice, and all
p.000004: this to ensure and protect the rights, safety and well-being of the subjects involved in the clinical trial;
p.000004: i) The examiner is the person responsible for conducting the clinical trial in the institution where it is conducted;
p.000004: j) The Principal Investigator is the investigator who is responsible for conducting the clinical trial of the medicinal product if clinical
p.000004: drug testing is conducted by the research team;
p.000004: k) The applicant is a person who participates in the clinical trial as a beneficiary of the investigational medicinal product
p.000004: the drug in the trial compares or placebo;
p.000004: l) Clinical Trial Report is a written report of the course of a clinical trial of any therapeutic,
p.000004: a prophylactic or diagnostic product, comprising clinical and statistical data processing, presentation, analysis and
p.000004: conclusions;
p.000004: m) Single or double blind examination means that the candidate does not know what he is receiving or that he does not
p.000004: the respondent, the examiner, or the competent observer do not know what anyone has received.
p.000004: n) Data coding categories
p.000004: Single-coded data and samples are marked with one specific code and do not imply any personal information
p.000004: identifiers. In the case of single coding, data or samples can be linked to a specific person
p.000004: using the encryption key. The clinical investigator is responsible for keeping the coding key. Since the samples and
p.000004: supporting information can be indirectly linked to the research subject, using a coding key, can be taken
p.000004: procedures such as drawing a sample or returning individual results at the request of the subject. Single use
p.000004: coded data and samples allows clinical monitoring, monitoring of the subject or supplementing of the subject's data.
p.000004: Single coding is currently the standard used in clinical research and offers an additional guarantee of
p.000004: subject identifiers, in relation to the general principles of trust in the health care system and privacy protection in
p.000004: daily medical practice;
...
p.000004: (Respondents' voluntary consent principles - Declaration of Helsinki)
p.000004: The principles of voluntary consent of the subjects must be applied in each clinical trial, in accordance with the provisions
p.000004: The Declaration of Helsinki, and in particular:
p.000004: a) the respondent is provided with information about the clinical trial in oral and written form;
p.000004: b) no compulsion to participate in the clinical trial is allowed;
p.000004: c) the respondents, their loved ones, guardians and legal representatives must be allowed to acquire
p.000004: knowledge of test details;
p.000004: d) the information "referred to in paragraph (3) of this Article" must contain a clear message that it is an examination, that participation
p.000004: in the clinical trial is voluntary and that refusal to participate, that is, refusal to participate in the trial
p.000004: freely;
p.000004: e) respondents must have sufficient time to decide whether or not they wish to participate in the examination;
p.000004: f) the subjects must be aware and agree to check the test results and be aware that it is
p.000004: participation in the examination protected as professional secrecy and as such made available to the public;
p.000004: g) the candidate must be informed about the insurance and treatment procedures for treatment in case of damage or
p.000004: disabilities caused by participation in a clinical trial;
p.000004: h) the respondent must know the circumstances under which the examiner or the applicant may terminate his examination
p.000004: participation in testing;
p.000004: i) the candidate must be fully informed of the examination, including the objective, the expected benefit for the respondent,
p.000004: ie other persons, control treatment / placebo, hazards and inconveniences (eg invasive procedures) and, where appropriate,
p.000004: interpretation of accepted alternative standard medical treatment;
p.000004: j) if the candidate is unable to give his or her personal consent to participate in the clinical trial of the medicinal product, if not
p.000004: awareness, that is, incapable of judgment, this consent can be given by parents, guardians, legal representatives,
p.000004: the spouse and if the examiner considers that participation may benefit the respondent's well-being and interests;
p.000004: k) if the candidate is a blind person, a deaf person who cannot read, a dumb person who cannot write and a deaf person
p.000004: A person makes a statement about participation in a clinical trial in the presence of one witness.
p.000004: Article 15
p.000004: (Requirements for clinical trial of a drug in minors)
p.000004: (1) If necessary and under special precautionary measures, clinical trials of the medicinal product may also be performed on persons
p.000004: up to 18 years of age who are ill or are in a condition for which the drug being tested is intended.
p.000004: (2) A clinical trial of a medicinal product involving juvenile subjects shall be conducted under the conditions prescribed by law and
p.000004: by this rulebook.
...
p.000004: d) to provide and deliver appropriately labeled and appropriately coded medicines for testing prepared in accordance with
p.000004: principles of Good Manufacturing Practice and properly packaged in such a way as to protect the product from damage, provided that it is
p.000004: process blindness ensured;
p.000004: e) keep sufficient samples of each batch and data on the analysis and characteristics of the product under test
p.000004: so that they can be re-examined if necessary by an independent laboratory;
p.000004: f) provide the examiner with the opportunity to establish in his institution a system for proper and safe handling,
p.000004: storage, privacy, return and destruction of the investigational medicinal product, and appoints a responsible person to perform these
p.000004: affairs;
p.000004: g) determine and provide training for the competent observer;
p.000004: h) designate persons to supervise the process and to verify the statistical processing and write the test report;
p.000004: i) to consider with the examiner without delay all side effects and take appropriate safety measures
p.000004: to submit the report of adverse reaction to the Agency;
p.000004: j) ensure that a full final test report is prepared;
p.000004: k) provide adequate compensation for the treatment or treatment for the subjects in case of damage or death
p.000004: related to the examination except for those resulting from malpractice or negligence.
p.000004: Article 25
p.000004: (Special obligations of test proponent)
p.000004: (1) In addition to the obligations "referred to in Article 24 of this Ordinance", the testing proponent shall be obliged to secure the supply of the medicinal product for
p.000004: test (test product or reference product, including placebo) so that they are appropriate
p.000004: quality and undergo quality assurance procedures.
p.000004: (2) The manner in which the test proponent supplies the examiner with the drugs under examination shall be
p.000004: described in the clinical trial protocol.
p.000004: (3) The proposer of the test shall supply the examiner with the drug when he has obtained the necessary clinical trial permit from
p.000004: Import Agencies and Consents by the Entity Ministries of Health.
p.000004: (4) The proponent of the test shall, when delivering the medicines "referred to in paragraph (3) of this Article," submit it to the examiner
p.000004: and written instructions on how to handle and store these medicines, as well as instructions on how to handle what they will after the test
p.000004: possibly remaining unused.
p.000004: (5) The proponent of the examination shall be obliged to draw up the delivery of medicines as well as the written instructions "from paragraph (4) of this Article"
p.000004: a written statement.
p.000004: (6) The test proponent must ensure the stability of the investigational medicinal product as well as its regular supply
p.000004: throughout the examination.
p.000004: (7) The proponent of the test shall be obliged to describe in detail the manner in which the investigational medicinal product will be labeled,
p.000004: deliver, distribute and store.
p.000004: (8) The notes must contain information on the transport, shipment, receipt, distribution, return and destruction of each
p.000004: of the remaining drug. The examiner must not administer the medication being tested to any person not designated to receive it.
p.000004: (9) The test proponent shall be responsible for the proper packaging and labeling of the investigational medicinal products. The mark must
p.000004: indicate that the product is for clinical trial use only.
p.000004: (10) In blind tests, the packaging must be labeled in such a way as to prevent identification. U
p.000004: emergency situations must be able to determine the identity of current treatment received by a particular respondent.
p.000004: (11) In blind studies, the drug to be tested, including the control drug and placebo, must be of equal value.
p.000004: appearance, taste, smell and other physical characteristics.
p.000004: (12) It is the responsibility of the test proponent to ensure that the packaging of the investigational medicinal product is of appropriate dimensions for
p.000004: testing and appropriate for the respondents and is required to provide sufficient samples of each batch used for the sake of
p.000004: needs for re-analysis and control in the future.
p.000004: (13) Should the formulation of the control drug change, the need for comparative in vivo biological consideration should be considered
p.000004: tests and test dissolution or other in vitro tests.
p.000004: Article 26
p.000004: (Clinical Trial Observer)
p.000004: (1) The competent observer shall be determined by the contracting authority with the consent of the examiner. The number of competent observers depends on
p.000004: the complexity of drug testing and the number of participating centers. The competent observer must be available to the examiner.
p.000004: (2) The primary obligation of the competent observer is to supervise the conduct of the test and to ensure that it is conducted in accordance with that
p.000004: test protocol.
p.000004: (3) Any unjustified deviation from the test protocol and any violation of Good Clinical Practice by a competent observer
p.000004: must, without delay, inform the investigator, the Agency and the professional institution where the clinical is performed
p.000004: examination.
p.000004: Article 27
p.000004: (Special Obligations of Clinical Trial Observer)
...
p.000004: no license:
p.000004: yes Earth, year and number
p.000004: do not allow: Storage conditions:
p.000004: Dosage in clinical trial:
p.000004: Active substance (s), name (for radiopharmaceuticals - radionuclide)
p.000004: Substance contained in a drug already registered in the world: no yes
p.000004: Countries where the medicine is registered,
p.000004: Registration year:
p.000004: Active substance manufacturer (name, address):
p.000004: Amount of active substance per unit dosage unit, per unit volume or per unit mass:
p.000004: The drug contains several active substances:
p.000004: yes Specify total number: no
p.000004: Comparative administration of another, registered medicinal product is permitted as standard for therapy:
p.000004: no
p.000004: Testing characteristics:
p.000004: Main Test Objective: Other Objectives:
p.000004: Therapeutic area:
p.000004: Cardiovascular CNS Respiratory
p.000004: Antiinfective Oncology Gastrointestinal Endocrinology
p.000004: Dermatology Others
p.000004: Test Phases: I II III IV Bioequivalence Test
p.000004: Types of testing:
p.000004: New indications Pharmacokinetic studies Dose determination New group
p.000004: patients New drug combination New pharmaceutical
p.000004: shape
p.000004: Increase the number of respondents Second tests
p.000004: Post-marketing testing Specify:
p.000004: If therapeutic effect is tested, provide indications:
p.000004: Test mode:
p.000004: Randomized Cross-Comparative Placebo Controlled
p.000004: Open Other
p.000004: Respondents:
p.000004: Single blind Specify:
p.000004: Healthy volunteers
p.000004: Double blind
p.000004: Patients
p.000004: Double dummy
p.000004: Number of patients: Total in all centers Total in BiH:
p.000004: Total number of respondents: Total number of respondents in BiH
p.000004: Single-center testing In multiple centers in BiH International multicenter
p.000004: in countries:
p.000004: Duration of drug administration:
p.000004: Single dose Repeated dose Specify number of days:
p.000004: Sunday: month:
p.000004: The period of thought after
p.000004: last take of the drug no yes
p.000004: Estimated test duration:
p.000004: Specify the monitoring period:
p.000004: Patient Involvement Criterion: Gender: Age:
p.000004: Disease:
p.000004: Institution at which the examination is carried out
p.000004: Name:
p.000004: Address (including postcode): Name of examiner:
p.000004: Laboratory tests shall be carried out in the laboratories of the institutions where the tests are carried out
p.000004: that not only in some Names and
p.000004: addresses of laboratories not part of the testing institutions
p.000004: Test quality control: yes
p.000004: no Monitor Oditor Other Specify:
p.000004: Indicative starting date of the test:
p.000004: The test is related to obtaining a marketing authorization in BiH: yes
p.000004: Clinical trial is already approved in other countries: yes country, license number,
...
p.000004: position or give consent under pressure. In this case, consent should be given to a physician who is not involved
p.000004: into the examination and which is completely independent.
p.000004: 11. If the respondent is not legally competent consent should be obtained from his legal representative in accordance with
p.000004: national legislation. Whenever a minor is in a position to give consent, it must be obtained with his consent
p.000004: legal representative.
p.000004: 12. The test plan must always include a statement of ethical elements and indicate that they are
p.000004: the principles of this declaration were respected.
p.000004: II Medical examination combined with professional supervision (clinical trial)
p.000004: 1. In treating a patient, the physician must be able to use new diagnostic and therapeutic measures, if any
p.000004: in his view, they offer hope for saving lives, restoring health and reducing suffering.
p.000004: 2. The potential benefits, dangers and inconveniences of the new method must be weighed against the benefits
p.000004: the best standard diagnostic and therapeutic methods.
p.000004: 3. In each clinical study, each patient, including one in the control group, should have, if available,
p.000004: the best, most proven diagnostic and therapeutic method available. That, in cases where there is no proven
p.000004: diagnostic or therapeutic methods, does not exclude the use of placebo.
p.000004: 4. A patient's refusal to participate in the examination should never affect his or her relationship with the physician.
p.000004: 5. If the doctor deems it necessary not to obtain consent, the specific reasons for this must be stated in the plan
p.000004: (protocol) tests, to be submitted to an independent representative.
p.000004: 6. The physician may combine medical examination with professional supervision in order to acquire new medical knowledge
p.000004: only to the extent that the test is justified in terms of its potential diagnostic or therapeutic
p.000004: values for the patient.
p.000004: III Non-therapeutic biomedical testing in humans (non-clinical biomedical testing)
p.000004: 1. In the purely scientific application of medical examination to humans, it is the duty of the physician to remain a protector
p.000004: the life and health of the person to be tested.
p.000004: 2. The subject must be a volunteer, healthy or ill, for whom the type of examination is not related to his or her own
p.000004: disease.
p.000004: 3. The examiner or examination team must suspend the tests if it concludes that further testing may be detrimental
p.000004: to the respondent.
p.000004: 4. In human inquiry, the interest of science and society can never be more important than the welfare of the respondents.
p.000004: 2004 Audits
p.000004: Every patient who has entered the study has the right to be treated by the best method and upon leaving the study.
p.000004: Testing of each new procedure should be compared according to the best existing method, where it exists, not
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| another country | Other Country |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| control group | participants in a control group |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| gender | gender |
| healthyXvolunteers | Healthy People |
| ill | ill |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| not conscious | Unconscious People |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| placebo | participants in a control group |
| prisoners | Criminal Convictions |
| single | Marital Status |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| drug | ['substance'] |
| parent | ['parents'] |
| parents | ['parent'] |
| placebo | ['controlXgroup'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input