A624E35EC511A22EA96BE3E7265ABF72

Policy on Ethical Research, Bioethics, and Scientific Integrity

https://minciencias.gov.co/sites/default/files/ckeditor_files/PDF%20Pol%c3%adtica.pdf

http://leaux.net/URLS/ConvertAPI Text Files/42E43D99092046E4C29730DC691BDCBA.en.txt

Examining the file media/Synopses/42E43D99092046E4C29730DC691BDCBA.html:

This file was generated: 2020-03-08 14:35:58

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	drug	10
Health	HIV/AIDS	HIV	1
Health	Health	health	15
Health	healthy volunteers	healthy volunteers	1
Social	Age	age	1
Social	Racial Minority	race	1
Social	Youth/Minors	minor	2
General/Other	Relationship to Authority	authority	1

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.(None): 3. DEFINITIONS
p.(None): Observational study: Study in which medications are prescribed in the usual way, according to the
p.(None): conditions established in the authorization. The assignment of a patient to a therapeutic strategy
p.(None): concrete will not be decided in advance by the protocol of an essay, but will be determined by practice
p.(None): usual of medicine, and the decision to prescribe a certain medication will be clearly dissociated from the
p.(None): decision to include the patient in the study. No intervention, whether diagnostic, will be applied to patients
p.(None): or follow-up, which is not the usual clinical practice, and epidemiological methods will be used for
p.(None): analysis of the data collected.1
p.(None): Phases of clinical research: 2
p.(None): Phase I: These are initial safety studies of a new medication, usually conducted in healthy volunteers.
p.(None): • Various dose ranges can be evaluated.
p.(None): • They can be done in patients with disease when the mechanism of action of the medication or ethical aspects so
p.(None): require (HIV or cancer).
p.(None): • Pharmacokinetic studies are usually considered phase I
p.(None): Phase II to:
p.(None): • Clinical trials (pilots) to evaluate efficacy and safety in selected patient population
p.(None): with the disease or condition to be treated, diagnosed or prevented.
p.(None): • The objectives can be: Dose-response, patient type, dose frequency, or questions of
p.(None): safety and efficacy.
p.(None): Phase II b:
p.(None): • Well-controlled trials to evaluate efficacy and safety in patients suffering from the condition or disease.
p.(None): • These are the clinical studies that usually represent the most rigorous demonstration of the efficacy of a drug.
p.(None): They are called pivot studies.
p.(None): Phase III to:
p.(None): • Trials performed after the efficacy of the drug was demonstrated, but before the
p.(None): regulatory submission of sanitary authorization.
p.(None): • Studies in patients where the drug is directed.
p.(None): • Efficacy and safety data + number of patients.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions (eg insufficiency
p.(None): renal).
p.(None): • Provide very important information for IPP and labeling in general.
p.(None): 1 Order SAS / 3470/2009, of December 16, by which the guidelines on post-authorization type studies are published
p.(None): Observatory for medicines for human use., December 25, 2009.
p.(None): 2 Ramirez R. and Soto N. Preclinical and Clinical Studies. Executive Directorate of Product Authorization and
p.(None): Establishments COFEPRIS Mexico
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 2 of 11
p.(None): Phase III b:
p.(None): • Clinical studies that are performed after regulatory submission and related dossiers, but before
p.(None): Be approved and released.
p.(None): • Quality of life studies.
p.(None): Phase IV with intervention:
p.(None): • Trials conducted after drug launch
p.(None): • Provides additional efficacy and safety data
p.(None): • Different formulations, doses, duration of Tx, interactions with others, and comparisons.
p.(None): • Population groups (age, race, gender)
p.(None): • Critical to collect security data.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions
p.(None): Critical or very serious deviations: procedures or practices that negatively affect rights, security or
p.(None): the well-being of the subjects or the quality and integrity of the data.3
p.(None): Major or serious deviations: procedures or practices that could negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data.3
p.(None): Minor deviations: procedures or practices that are not expected to negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data. 3
p.(None): Amendment to the project: Written description of change (s) or formal clarification of a project4.
p.(None): Relevant Amendment: Those modifications of the protocol that may affect the safety of the
p.(None): subjects of study or of modifying the interpretation of the scientific evidence that supports the development of the study
p.(None): or are significant from any other point of view that affect the benefit / risk balance for
p.(None): the participating subjects5.
p.(None): Amendment Not relevant: All modifications to the protocol that do not affect the security of
p.(None): the subjects of studies, do not modify the interpretation of the scientific evidence that supports the development of
...

p.(None): Page 4 of 11
p.(None): • The main endpoint variable is objective and clinically relevant.
p.(None): • The criteria for evaluating the response have valid methods.
p.(None): • The failure criteria are specified.
p.(None): • It is allowed to replace losses.
p.(None): • All study information will be recorded so that it can be reported, interpreted and verified.
p.(None): precise way.
p.(None): • The data collection tool is adequate.
p.(None): • There is a format where adverse events are recorded.
p.(None): • The method of notification of the adverse event to the sponsor is specified.
p.(None): • Medical attention will be guaranteed to study subjects in case of an adverse event related to the
p.(None): study medication.
p.(None): • The patient care mechanism is specified, if an adverse event associated with the product occurs,
p.(None): while accessing the policy.
p.(None): • It has a contractual and extra contractual policy for adverse events associated and attributable to the product of
p.(None): investigation.
p.(None): • Procedures that guarantee the quality of each aspect of the project will be sufficiently and correctly implemented.
p.(None): study
p.(None): In accordance with the Phase of the clinical study to be submitted, in addition to the above, attention should be paid to:
p.(None): Phase I:
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher).
p.(None): • Adequate target population.
p.(None): • Sample size suitable for the study.
p.(None): Phase II:
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher)
p.(None): • Adequate target population
p.(None): • Sample size suitable for the study
p.(None): • Safety and tolerability of the research drug in humans.
p.(None): • Complete pharmacokinetic information of the research drug in humans.
p.(None): Phase III
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher)
p.(None): • Adequate target population
p.(None): • Sample size suitable for the study
p.(None): • Justified information of the investigational medicine regarding safety and efficacy in
p.(None): preliminary phases (phase I and phase II)
p.(None): • Updated information on the investigator's manual, regarding the research medication.
p.(None): Researcher's Manual: This document must contain all the information available from previous clinical studies
p.(None): (phase I, II, III as the case may be) on safety data of the molecule under investigation as
p.(None): toxicity, teratogenicity, pharmacodynamics, pharmacokinetics, physical and chemical properties, interactions with
p.(None): medications and / or food, side effects and adverse reactions, making clear the possible risks
p.(None): that can occur during the study. In addition, the investigator's manual must contain information
p.(None): Reliable from previous pre-clinical studies that justify the use of the molecule in humans.
p.(None): Informed Consent (ICF): The ethics committee should evaluate aspects such as materials and methods that are going to be
p.(None): used to obtain informed consent to the subjects participating in the clinical study, such as
p.(None): the
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
...

p.(None): availability of an insurance policy in case of compensation or compensation, and the management of the
p.(None): data confidentiality, among others. The document must have a clear, legible letter with adequate information
p.(None): for the sociocultural level at the place of application, it must not be extensive, unambiguous and everything
p.(None): referred to in Resolution 8430 of 1993. It should be taken into account that the participation of minors
p.(None): It must follow the guidelines established in the mentioned resolution or in current sanitary norms.
p.(None): Likewise, informed consent must be evaluated for genetic samples, in which the sponsor specifies
p.(None): how these samples are going to be used, the time in which the destruction and the handling of the
p.(None): Confidentiality of this information. Take into account the guidelines for informed consents established in
p.(None): the Guide for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): research protocols ASS-RSA-GU031
p.(None): Amendments to the protocol (If applicable): When the modifications are relevant, that is to say that they affect the security of the
p.(None): participant or modify the design, statistical treatment and / or interpretation of the tests in the protocol,
p.(None): they should evaluate these characteristics in such a way that the integrity of
p.(None): Participating subjects It is important to consider that a relevant amendment may have the following
p.(None): Features: Changes in the safety and integrity of test subjects, change in criteria of
p.(None): inclusion and exclusion, extension of the window period, change in protocol design, statistical analysis,
p.(None): sample size, changes related to the drug, change in procedures, modification of
p.(None): efficacy and safety parameters, or those characteristics that the Ethics Committee considers in
p.(None): investigation. Take into account the guidelines for informed consents established in the
p.(None): Guide for the presentation of amendments, new centers, new researchers and informed consent
p.(None): of research protocols ASS-RSA-GU031
p.(None): 5. MAXIMUM EVALUATION TIME
p.(None): The clinical research protocol evaluation process is in charge of the Clinical Research Group of the
p.(None): Directorate of Medicines and Biological Products of Invima, with a maximum time of two (2) months to give
p.(None): response to the interested party
p.(None): NOTE: For the Clinical Research Protocols of impact on Public Health, the
p.(None): prioritization in its evaluation.
p.(None): 6. GUIDELINES FOR THE FOLLOW-UP OF RESEARCH PROTOCOLS
p.(None): The monitoring of research protocols is done in two different ways like this:
p.(None): 6.1 Evaluation of the documents related to the research protocol that must be submitted to the Invima:
p.(None): The documents referenced below must be submitted to the Clinical Research Group of the
p.(None): Directorate of Medicines and Biological Products, who will evaluate and analyze the approval or not
p.(None): documents:
p.(None): • Amendment to the protocol, new centers, new investigators and informed consents: You must complete
p.(None): the Format for the presentation of amendments, new centers, new researchers and
p.(None): informed consent of research protocols ASS-RSA-FM047, according to the Guide for the
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
...

p.(None): causality of the adverse event. Similarly, within the analysis performed by the ethics committee, you can qualify
p.(None): to the adverse event differently.
p.(None): The research center must have established the processes / activities that should be carried out in case
p.(None): that an adverse event occurs in order to ensure timely and adequate medical attention to the subjects
p.(None): participants.
p.(None): Research Product:
p.(None): The handling of the research product must be under the responsibility of a qualified professional
p.(None): (Pharmaceutical Chemist), according to what is established for the management of a Pharmaceutical Service in the regulations
p.(None): National in force.
p.(None): Among its processes / activities is the reception, storage, accounting, informed dispensation, destruction and / or
p.(None): return of the research product, among many others that according to their knowledge and capabilities can
p.(None): develop. All of the above must be documented and have records implemented that allow
p.(None): make traceability
p.(None): As for the dispensing of investigational drugs, an agile, safe, reliable and useful process must be created
p.(None): for the medication request, which must be supported by the information or assignment given by the Interactive
p.(None): Voice Response System (IVRS). With this information the Pharmaceutical Chemist must deliver to the participating subject the
p.(None): investigational medication and inform in a clear and common vocabulary the use and storage of the medication, it is
p.(None): say, among other things, transport conditions, storage conditions and taking times; this in order to
p.(None): avoid or reduce the risk of drug interaction with concomitant medication. Therefore it is responsibility
p.(None): within the dispensation generate information mechanisms to ensure that the subject has complete information and
p.(None): adequate management of the investigational medication, such as through brochures, which should be
p.(None): previously evaluated and approved by the Research Ethics Committee.
p.(None): During the storage process, the Pharmaceutical Chemist is responsible for monitoring the conditions of
p.(None): Storage of research products, is also responsible for ensuring the control of dates
p.(None): of expiration of these products to avoid expiring expired medications to research subjects.
p.(None): As stated in the Colombian regulations for the management of expired medication or with
p.(None): Obvious problems in terms of quality or that by prior authorization of the sponsor must be removed, must
p.(None): There is a separate and identified storage area.
p.(None): With respect to the return and / or destruction of the investigational drug, a
p.(None): Process implemented in which records of this activity are kept. In cases that are returned
p.(None): the medicine to the sponsor or sent to another institution for its destruction, is the responsibility of the Center of
p.(None): investigation require a copy of this process, which should rest in the file where control of the
p.(None): medicine guaranteeing the management of the inventory of the product under investigation in a clear and reliable way.
p.(None): For the latter case, databases may be developed where at least the following are specified
p.(None): fields: medication identification code, expiration date, lot number, date received in
p.(None): the center, date of dispensation, data of the research subject, date of return of medications to
p.(None): center (if applicable) and return date to the sponsor or CRO (Contract Research Organization) (if applicable).
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 10 of 11
p.(None): It is important to remember that it is the responsibility of the Principal Investigator and / or the Pharmaceutical Chemist to carry out
p.(None): follow up to treatment adherence.
p.(None): Coordination of clinical studies
p.(None): Within the institution there must be a specific site where the administrative part of the
p.(None): research study, which must have the infrastructure, space, technical capacity and human resources
p.(None): competent, according to the number, complexity and difficulty of the research studies carried out
...

p.(None): RSA-FM046
p.(None): • Format for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): ASS-RSA-FM047 research protocols
p.(None): Guide for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): research protocols ASS-RSA-GU031
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 11 of 11
p.(None): • Format for Notification of Closure of Clinical Studies (Protocols) ASS-RSA-FM049
p.(None): Guide for Notification of Closure of Clinical Studies (Protocols) ASS-RSA-GU033
p.(None): • Format for Presentation and Evaluation of New Requests for Importing Supplies for
p.(None): Research protocols ASS-RSA-FM052
p.(None): Presentation and Evaluation Format for New Applications for the Export of Biological Samples for
p.(None): ASS-RSA-FM053 Research protocols
p.(None): Guide for the Presentation of New Requests for Importing Supplies and Exporting Samples
p.(None): Biological for research protocols ASS-RSA-GU036
p.(None): • Format Annual Report of Research Projects ASS-RSA-FM063
p.(None): Guide for the completion of the annual research project format ASS-RSA-GU041
p.(None): • Presentation format and evaluation of modifications to the ASS-RSA-FM054 researcher's manual
p.(None): Guide for the Presentation and Evaluation of Modifications to the ASS-RSA-GU037 Investigator Manual
p.(None): • Format for the presentation of studies of drug stability in research ASS-RSA-FM088
p.(None): Guide for the Presentation of Research Stability Studies in Research ASS-RSA-GU055
p.(None): • Guide for Research Ethics Committees ASS-RSA-GU040
p.(None): • Guide for Medicines and Clinical Research Supplies ASS-RSA-GU045
p.(None): • Guide for the completion of the adverse event report formats in research protocols ASS-
p.(None): RSA-GU057
p.(None): • Format deviation notification in clinical trials ASS-RSA-FM101
p.(None): • List of research protocols developed by the institution (IPS): active and closed studies
p.(None): ASS-AYC- FM046
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
...

Health / HIV/AIDS

Searching for indicator HIV:

(return to top)
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 1 of 11
p.(None): 1. OBJECTIVE:
p.(None): Publicize the guidelines for evaluation, monitoring and completion of the protocols for
p.(None): research with medicines that are carried out in Colombia.
p.(None): 2. REACH:
p.(None): This guide is applicable to Sponsors or whoever does their time, Research Organizations for
p.(None): Contract (OIC) or CRO in its acronym in English, Ethics Committees (IEC), Research Centers,
p.(None): Researchers and their Research team involved in the development of a Research Protocol with
p.(None): Medicines in humans.
p.(None): 3. DEFINITIONS
p.(None): Observational study: Study in which medications are prescribed in the usual way, according to the
p.(None): conditions established in the authorization. The assignment of a patient to a therapeutic strategy
p.(None): concrete will not be decided in advance by the protocol of an essay, but will be determined by practice
p.(None): usual of medicine, and the decision to prescribe a certain medication will be clearly dissociated from the
p.(None): decision to include the patient in the study. No intervention, whether diagnostic, will be applied to patients
p.(None): or follow-up, which is not the usual clinical practice, and epidemiological methods will be used for
p.(None): analysis of the data collected.1
p.(None): Phases of clinical research: 2
p.(None): Phase I: These are initial safety studies of a new medication, usually conducted in healthy volunteers.
p.(None): • Various dose ranges can be evaluated.
p.(None): • They can be done in patients with disease when the mechanism of action of the medication or ethical aspects so
p.(None): require (HIV or cancer).
p.(None): • Pharmacokinetic studies are usually considered phase I
p.(None): Phase II to:
p.(None): • Clinical trials (pilots) to evaluate efficacy and safety in selected patient population
p.(None): with the disease or condition to be treated, diagnosed or prevented.
p.(None): • The objectives can be: Dose-response, patient type, dose frequency, or questions of
p.(None): safety and efficacy.
p.(None): Phase II b:
p.(None): • Well-controlled trials to evaluate efficacy and safety in patients suffering from the condition or disease.
p.(None): • These are the clinical studies that usually represent the most rigorous demonstration of the efficacy of a drug.
p.(None): They are called pivot studies.
p.(None): Phase III to:
p.(None): • Trials performed after the efficacy of the drug was demonstrated, but before the
p.(None): regulatory submission of sanitary authorization.
p.(None): • Studies in patients where the drug is directed.
p.(None): • Efficacy and safety data + number of patients.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions (eg insufficiency
p.(None): renal).
p.(None): • Provide very important information for IPP and labeling in general.
p.(None): 1 Order SAS / 3470/2009, of December 16, by which the guidelines on post-authorization type studies are published
p.(None): Observatory for medicines for human use., December 25, 2009.
p.(None): 2 Ramirez R. and Soto N. Preclinical and Clinical Studies. Executive Directorate of Product Authorization and
p.(None): Establishments COFEPRIS Mexico
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
...

Health / Health

Searching for indicator health:

(return to top)
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 1 of 11
p.(None): 1. OBJECTIVE:
p.(None): Publicize the guidelines for evaluation, monitoring and completion of the protocols for
p.(None): research with medicines that are carried out in Colombia.
p.(None): 2. REACH:
p.(None): This guide is applicable to Sponsors or whoever does their time, Research Organizations for
p.(None): Contract (OIC) or CRO in its acronym in English, Ethics Committees (IEC), Research Centers,
p.(None): Researchers and their Research team involved in the development of a Research Protocol with
p.(None): Medicines in humans.
p.(None): 3. DEFINITIONS
p.(None): Observational study: Study in which medications are prescribed in the usual way, according to the
p.(None): conditions established in the authorization. The assignment of a patient to a therapeutic strategy
p.(None): concrete will not be decided in advance by the protocol of an essay, but will be determined by practice
p.(None): usual of medicine, and the decision to prescribe a certain medication will be clearly dissociated from the
p.(None): decision to include the patient in the study. No intervention, whether diagnostic, will be applied to patients
p.(None): or follow-up, which is not the usual clinical practice, and epidemiological methods will be used for
p.(None): analysis of the data collected.1
p.(None): Phases of clinical research: 2
p.(None): Phase I: These are initial safety studies of a new medication, usually conducted in healthy volunteers.
p.(None): • Various dose ranges can be evaluated.
...

p.(None): • Pharmacokinetic studies are usually considered phase I
p.(None): Phase II to:
p.(None): • Clinical trials (pilots) to evaluate efficacy and safety in selected patient population
p.(None): with the disease or condition to be treated, diagnosed or prevented.
p.(None): • The objectives can be: Dose-response, patient type, dose frequency, or questions of
p.(None): safety and efficacy.
p.(None): Phase II b:
p.(None): • Well-controlled trials to evaluate efficacy and safety in patients suffering from the condition or disease.
p.(None): • These are the clinical studies that usually represent the most rigorous demonstration of the efficacy of a drug.
p.(None): They are called pivot studies.
p.(None): Phase III to:
p.(None): • Trials performed after the efficacy of the drug was demonstrated, but before the
p.(None): regulatory submission of sanitary authorization.
p.(None): • Studies in patients where the drug is directed.
p.(None): • Efficacy and safety data + number of patients.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions (eg insufficiency
p.(None): renal).
p.(None): • Provide very important information for IPP and labeling in general.
p.(None): 1 Order SAS / 3470/2009, of December 16, by which the guidelines on post-authorization type studies are published
p.(None): Observatory for medicines for human use., December 25, 2009.
p.(None): 2 Ramirez R. and Soto N. Preclinical and Clinical Studies. Executive Directorate of Product Authorization and
p.(None): Establishments COFEPRIS Mexico
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 2 of 11
p.(None): Phase III b:
p.(None): • Clinical studies that are performed after regulatory submission and related dossiers, but before
p.(None): Be approved and released.
p.(None): • Quality of life studies.
p.(None): Phase IV with intervention:
p.(None): • Trials conducted after drug launch
p.(None): • Provides additional efficacy and safety data
p.(None): • Different formulations, doses, duration of Tx, interactions with others, and comparisons.
p.(None): • Population groups (age, race, gender)
p.(None): • Critical to collect security data.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions
p.(None): Critical or very serious deviations: procedures or practices that negatively affect rights, security or
p.(None): the well-being of the subjects or the quality and integrity of the data.3
p.(None): Major or serious deviations: procedures or practices that could negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data.3
p.(None): Minor deviations: procedures or practices that are not expected to negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data. 3
p.(None): Amendment to the project: Written description of change (s) or formal clarification of a project4.
p.(None): Relevant Amendment: Those modifications of the protocol that may affect the safety of the
...

p.(None): the subjects of studies, do not modify the interpretation of the scientific evidence that supports the development of
p.(None): essay and are not significant from any other point of view, which affect the balance
p.(None): benefit / risk for participating subjects.5
p.(None): Sponsor2: Individual, company, institution or organization responsible for initiating, administering / controlling and / or
p.(None): Fund a clinical study. This function can be performed by a corporation or agency outside the institution
p.(None): or by the researcher or hospital institution.
p.(None): 4. GUIDELINES FOR THE INITIAL PRESENTATION OF RESEARCH PROTOCOLS FOR THEIR EVALUATION
p.(None): According to Resolution 2378 of 2008 and 3823 of 1997, sponsors have the obligation to
p.(None): submit for approval by the Invima (Directorate of Medicines and Biological Products) the protocols of
p.(None): research with medicines carried out in Colombia between Phase I and Phase IV (with intervention)
p.(None): which are evaluated by the Clinical Research Group. Phase research protocols
p.(None): Observational IV (Observational studies) do not have to be submitted for approval by the Invima.
p.(None): 3 Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
p.(None): (Inspection reports to EMA 2000-2012). European Medicines Agency. 01 December 2014. INS / GCP / 46309/2012
p.(None): 4 Resolution 2378 of 2008
p.(None): 5 Directive 2001/20 / EC of the European Parliament and of the Council of April 4, 2001; Article 10; Item a) - Address
p.(None): of Medicines and Biological Products
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 3 of 11
p.(None): Therefore the documents must be submitted to the Clinical Research Group of the Directorate of Medicines and
p.(None): Biological Products of the Invima, complying with the requirements specified in the Presentation Format
p.(None): and Evaluation of Research Protocols ASS-RSA-FM055.
p.(None): This submission must be in accordance with the provisions of the Presentation and Evaluation Format of the
p.(None): Research ASS-RSA-FM055 and Checklist format for receiving documents related to
p.(None): ASS-RSA-FM046 research protocols and the others that they relate to.
p.(None): The decision of the evaluation of the protocol (approval or not), will be notified to the sponsor by means of a
p.(None): administrative act Likewise, a list of the Research Protocols can be found on the Invima website
p.(None): Clinic submitted to the Clinical Research Group, which is updated monthly.
p.(None): Note: The extension of a study is considered as a new research protocol, so it must be submitted
p.(None): as such.
p.(None): EVALUATION OF THE PROTOCOL BY THE ETHICS COMMITTEE:
p.(None): Before submitting a new clinical study to Invima, it must be evaluated by a Committee (s) of
p.(None): Research Ethics attached to the certification in Good Clinical Practices of a Research Center.
p.(None): This evaluation must be completed in “PART II: INFORMATION ABOUT THE PROTOCOL OF
p.(None): RESEARCH TO BE DILIGENCED BY THE RESEARCH ETHICS COMMITTEE (CEI) ”
...

p.(None): Research protocol to Invima and will be carried out based on what is established in the regulations
p.(None): in force and the Guide for the presentation of the amendments, new centers, new researchers and consents
p.(None): informed of research protocols ASS-RSA-GU031
p.(None): Research Protocol: Evaluation of the aspects that imply the technical quality of the
p.(None): clinical study, as well as its subsequent development at the research site. Among the minimum aspects to
p.(None): evaluate are:
p.(None): • The study will be conducted according to the ethical principles set forth in the Helsinki Declaration, the guidelines
p.(None): of Good Clinical Practice and regulatory requirements (Resolution 8430 of 1993 and Resolution 2378 of
p.(None): 2008 or current applicable standards)
p.(None): • The realization of the Research Protocol is justified according to the available knowledge
p.(None): • The risks in relation to the benefits, for the subject of study and for society, have been the
p.(None): sufficiently compared.
p.(None): • It has a theoretical foundation.
p.(None): • There is a fundamental objective.
p.(None): • The protocol design is adequate.
p.(None): • The statistical design is adequate.
p.(None): • There is a plan for analyzing the results.
p.(None): • The inclusion and exclusion criteria are adequately specified.
p.(None): • The protocol is reproducible.
p.(None): • If placebo is used, its use is justified.
p.(None): • Supportive therapy is used.
p.(None): • Concomitant treatment is specified.
p.(None): • A washing period is necessary.
p.(None): • The allocation of treatment to research subjects is appropriate.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 4 of 11
p.(None): • The main endpoint variable is objective and clinically relevant.
p.(None): • The criteria for evaluating the response have valid methods.
p.(None): • The failure criteria are specified.
p.(None): • It is allowed to replace losses.
p.(None): • All study information will be recorded so that it can be reported, interpreted and verified.
p.(None): precise way.
p.(None): • The data collection tool is adequate.
p.(None): • There is a format where adverse events are recorded.
p.(None): • The method of notification of the adverse event to the sponsor is specified.
p.(None): • Medical attention will be guaranteed to study subjects in case of an adverse event related to the
p.(None): study medication.
p.(None): • The patient care mechanism is specified, if an adverse event associated with the product occurs,
p.(None): while accessing the policy.
p.(None): • It has a contractual and extra contractual policy for adverse events associated and attributable to the product of
p.(None): investigation.
p.(None): • Procedures that guarantee the quality of each aspect of the project will be sufficiently and correctly implemented.
p.(None): study
p.(None): In accordance with the Phase of the clinical study to be submitted, in addition to the above, attention should be paid to:
p.(None): Phase I:
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher).
p.(None): • Adequate target population.
p.(None): • Sample size suitable for the study.
p.(None): Phase II:
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher)
...

p.(None): • Complete pharmacokinetic information of the research drug in humans.
p.(None): Phase III
p.(None): • Complete pre-clinical information (review of the pre-clinical information available in the manual
p.(None): of the researcher)
p.(None): • Adequate target population
p.(None): • Sample size suitable for the study
p.(None): • Justified information of the investigational medicine regarding safety and efficacy in
p.(None): preliminary phases (phase I and phase II)
p.(None): • Updated information on the investigator's manual, regarding the research medication.
p.(None): Researcher's Manual: This document must contain all the information available from previous clinical studies
p.(None): (phase I, II, III as the case may be) on safety data of the molecule under investigation as
p.(None): toxicity, teratogenicity, pharmacodynamics, pharmacokinetics, physical and chemical properties, interactions with
p.(None): medications and / or food, side effects and adverse reactions, making clear the possible risks
p.(None): that can occur during the study. In addition, the investigator's manual must contain information
p.(None): Reliable from previous pre-clinical studies that justify the use of the molecule in humans.
p.(None): Informed Consent (ICF): The ethics committee should evaluate aspects such as materials and methods that are going to be
p.(None): used to obtain informed consent to the subjects participating in the clinical study, such as
p.(None): the
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 5 of 11
p.(None): budgeted time for the taking of informed consent, which contemplates the pertinent information to
p.(None): bias-free research, which explains the coverage of the attention of adverse events, the possible
p.(None): risks and expected benefits, completely voluntary participation and which can be abandoned in
p.(None): any time of the study without the participant having a negative effect on health care, others
p.(None): alternative treatments when applicable, the schedule, number of visits and laboratory tests that
p.(None): will be made to the participant, the budget for food and transportation when applicable, the
p.(None): availability of an insurance policy in case of compensation or compensation, and the management of the
p.(None): data confidentiality, among others. The document must have a clear, legible letter with adequate information
p.(None): for the sociocultural level at the place of application, it must not be extensive, unambiguous and everything
p.(None): referred to in Resolution 8430 of 1993. It should be taken into account that the participation of minors
p.(None): It must follow the guidelines established in the mentioned resolution or in current sanitary norms.
p.(None): Likewise, informed consent must be evaluated for genetic samples, in which the sponsor specifies
p.(None): how these samples are going to be used, the time in which the destruction and the handling of the
p.(None): Confidentiality of this information. Take into account the guidelines for informed consents established in
p.(None): the Guide for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): research protocols ASS-RSA-GU031
p.(None): Amendments to the protocol (If applicable): When the modifications are relevant, that is to say that they affect the security of the
p.(None): participant or modify the design, statistical treatment and / or interpretation of the tests in the protocol,
p.(None): they should evaluate these characteristics in such a way that the integrity of
p.(None): Participating subjects It is important to consider that a relevant amendment may have the following
p.(None): Features: Changes in the safety and integrity of test subjects, change in criteria of
p.(None): inclusion and exclusion, extension of the window period, change in protocol design, statistical analysis,
p.(None): sample size, changes related to the drug, change in procedures, modification of
p.(None): efficacy and safety parameters, or those characteristics that the Ethics Committee considers in
p.(None): investigation. Take into account the guidelines for informed consents established in the
p.(None): Guide for the presentation of amendments, new centers, new researchers and informed consent
p.(None): of research protocols ASS-RSA-GU031
p.(None): 5. MAXIMUM EVALUATION TIME
p.(None): The clinical research protocol evaluation process is in charge of the Clinical Research Group of the
p.(None): Directorate of Medicines and Biological Products of Invima, with a maximum time of two (2) months to give
p.(None): response to the interested party
p.(None): NOTE: For the Clinical Research Protocols of impact on Public Health, the
p.(None): prioritization in its evaluation.
p.(None): 6. GUIDELINES FOR THE FOLLOW-UP OF RESEARCH PROTOCOLS
p.(None): The monitoring of research protocols is done in two different ways like this:
p.(None): 6.1 Evaluation of the documents related to the research protocol that must be submitted to the Invima:
p.(None): The documents referenced below must be submitted to the Clinical Research Group of the
p.(None): Directorate of Medicines and Biological Products, who will evaluate and analyze the approval or not
p.(None): documents:
p.(None): • Amendment to the protocol, new centers, new investigators and informed consents: You must complete
p.(None): the Format for the presentation of amendments, new centers, new researchers and
p.(None): informed consent of research protocols ASS-RSA-FM047, according to the Guide for the
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 6 of 11
p.(None): presentation of the amendments, new centers, new researchers and informed consents of
p.(None): research protocols ASS-RSA-GU031
p.(None): • Stability Studies: The Format for the presentation of studies of
p.(None): stability of investigational drugs ASS-RSA-FM088 according to the Guide for the presentation of
p.(None): stability studies of research drugs ASS-RSA-GU055
p.(None): • New requests for Import of Supplies and Export of Biological Samples:
p.(None): fill out the presentation and evaluation format for new import requests for supplies for
p.(None): ASS-RSA-FM052 research protocols and Presentation and evaluation format for new export applications
p.(None): of biological samples for research protocols ASS-RSA-FM053 according to the Guide for
p.(None): presentation of new requests for import of supplies and export of biological samples for protocols
p.(None): ASS-RSA-GU036
p.(None): • Modifications to the Investigator Manual: The Presentation and Evaluation Format of
p.(None): modifications to the ASS-RSA-FM054 researcher's manual according to the Presentation Guide and
p.(None): Evaluation of modifications to the researcher's manual ASS-RSA-GU037.
p.(None): • Annual Report: The Annual Report of Research Projects FormatASS-RSA-FM063 must be completed in accordance
p.(None): to the Guide for the Diligenciamiento of the Annual Format of Projects of Investigation ASS-RSA-GU041
p.(None): • Protocol Closure: The format for notification of closure of clinical studies (protocols) must be completed.
p.(None): ASS-RSA-FM049 according to the Guide for notification of closure of clinical studies (protocols) ASS-RSA- GU033
...

p.(None): Below are some guidelines for conducting a clinical study protocol within a Center for
p.(None): Research, which can be evaluated in follow-up visits.
p.(None): • The development of a clinical study in the country cannot begin until a concept of
p.(None): approval by Invima.
p.(None): • The research center must have a manual where all aspects are contemplated
p.(None): general operations about the investigation procedure. This manual must be approved by the representative
p.(None): legal of the institution and be aligned to its quality management system. In addition, a
p.(None): manual of functions and / or responsibilities of the research team and have documented the policy of
p.(None): conflicts of interest and confidentiality policy.
p.(None): • Each institution has the responsibility of verifying by means of a documented procedure, the supports of the
p.(None): Resumes of researchers and other members of the research team, including validation of the
p.(None): Information from undergraduate and graduate studies.
p.(None): • The clinical study must be conducted in accordance with current regulations and as defined by the Ethics Committee in
p.(None): Research, therefore should have the right amount of human resources, infrastructure and technical tools.
p.(None): • The medical history must be unified, according to Resolution 1995 of 1999; is the document
p.(None): source par excellence and must record all data related to the medical act, the application of
p.(None): inclusion and exclusion criteria, acceptance of informed consent and allocation procedure
p.(None): random of
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 7 of 11
p.(None): Participating subjects There should not be a parallel medical history within the file
p.(None): investigation study. A copy of the medical record may be included but this must be constantly updated.
p.(None): and be consistent with the original medical history.
p.(None): • The clinical study must have source documents that allow verifying the information
p.(None): Registered to the sponsor through the Data Collection Notebook (Case Report Forms - CRF).
p.(None): • The inclusion of participating subjects should be done according to the research protocol, maintaining the
p.(None): confidentiality
p.(None): • All medical decisions must be in charge of a medical professional with scientific competence
p.(None): adequate care.
p.(None): • Any document delivered to the participating subject, such as recruitment announcements, clinical study material
p.(None): among others, they must have been previously evaluated according to the confidentiality parameters and
p.(None): Well-being with the subject.
p.(None): • Informed consent and / or informed consent, regardless of type (general, genetic, etc.), must be
p.(None): reviewed and approved by the Research Ethics Committee, must comply with current regulations and must be
p.(None): applied only by the IP or IS, who fully knows the clinical research protocol and the specialty
p.(None): of the same. On the other hand it must be done in a suitable place for reading, where the possible participant subject
p.(None): I can read it calmly without time pressures. This must be signed, accepted and understood by
p.(None): part of the participant before starting any procedure and must be supported in the document
p.(None): main source that is the medical history.
p.(None): • In order to fully guarantee the understanding of informed consent by the
p.(None): participants, mechanisms should be sought to assess the ability to understand and be
p.(None): Documented supported.
p.(None): • It should be clarified that in the case that the participating subject is a minor, it must be
p.(None): apply informed consent according to current regulations and consent
p.(None): informed to the responsible adult.
p.(None): Research Team:
p.(None): This is responsible for carrying out the development of the clinical study protocol in the research center,
p.(None): led by the principal investigator and made up of health professionals according to the characteristics of
p.(None): Each study The minimum members that it must contain are:
p.(None): • Principal investigator (IP): He is responsible for the research protocol he assumes, so
p.(None): both is responsible for the entire research team, who may delegate functions according to
p.(None): The suitability of each professional. You must have full knowledge of the protocol, methodology, background, driving,
p.(None): file and all aspects that have to do with the clinical research study and therefore has the
p.(None): ability to support an audit or monitoring visit.
p.(None): • Secondary researcher (IS): Is the person in which the researcher delegates specific clinical or clinical functions.
p.(None): procedure in the research study. It may be one or more secondary researchers.
p.(None): • Research coordinator: The research coordinator must be a professional in the area of health,
p.(None): delegate to handle the administrative aspects of the study. You must have the experience and suitability in
p.(None): research evaluated and defined by the research ethics committee. You can carry out several studies of
p.(None): according to their technical and labor capacity, however the number of clinical studies should be considered
p.(None): and patients in charge to avoid overreaching their burden.
p.(None): • Pharmaceutical chemist: Is the person responsible for all product handling of
p.(None): research (medications and supplies), from receipt, storage, accounting, dispensing and return
p.(None): and / or destruction. On the other hand it is a support for the analysis of the Adverse Events that are presented and to perform
p.(None): Pharmaceutical care activities
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 8 of 11
p.(None): • Bacteriologist (a): Is the person responsible for taking, packing, shipping, conservation and
p.(None): Sample processing required by the clinical studies protocol.
p.(None): The research team must have designed a work plan that includes the functions and times that
p.(None): must comply according to the processes carried out in each of the protocols under its responsibility,
p.(None): These same functions must be registered in the format of responsibilities (log responsability) of each study.
p.(None): The work plan is subject to verification in follow-up visits to protocols and to the
p.(None): Certification in Good Clinical Practices by Invima. On the other hand the Principal Investigator
p.(None): As leader of the research team, you should review and monitor the processes performed by each member.
p.(None): Every member of the research team must be trained in Good Clinical Practices through a face-to-face course
p.(None): or virtual, which must include training in national regulations in force in research, before
p.(None): come into contact with the research subject.
p.(None): The research team must have constant training according to the needs it deems relevant in
p.(None): the investigation process (BPC) or the protocols that are being carried out.
p.(None): The research team must guarantee the adherence of the participating subject to the research protocol, through
p.(None): of different internally created procedures. These procedures must be previously approved by the committee
p.(None): of ethics
p.(None): Ethical Regulations:
...

p.(None): make periodic, annual and final reports of each protocol in clinical research, which must be submitted
p.(None): to the Ethics Committee and the sponsor to consolidate it and send a final report of the study to Invima.
p.(None): The researcher must have available for review all records, correspondences, budget and
p.(None): other documents submitted and approved by the Ethics Committee, which may be subject to
p.(None): audit by the competent authorities and by the Ethics Committee when required.
p.(None): The ethics committee must verify that the policy is in force, which covers the adverse events of the study,
p.(None): compensation in case of death and you must also verify the accessibility of said policy, you must also verify
p.(None): the processes for the attention of the adverse events of the participating subjects, while accessing
p.(None): The insurance policy.
p.(None): Note: The Ethics Committee is the highest authority at the research site, however the principal investigator
p.(None): You can use the resource to inform the Invima of any observations or inconsistencies generated from the
p.(None): ethics committee in its approvals according to current regulations.
p.(None): Adverse events:
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 9 of 11
p.(None): Adverse events that are generated in the development of clinical research protocols should be reported as
p.(None): according to the regulations in force to the sponsor and / or regulatory agency in the corresponding formats according to the
p.(None): Guide for the completion of the adverse event report formats in ASS-RSA- research protocols
p.(None): GU057. On the other hand these must be registered in the adverse event report formats of the protocol of
p.(None): corresponding investigation.
p.(None): The principal investigator according to his knowledge, criteria, competence and experience within the
p.(None): Research study and / or with the support of the research team professionals should determine the
p.(None): causality of the adverse event. Similarly, within the analysis performed by the ethics committee, you can qualify
p.(None): to the adverse event differently.
p.(None): The research center must have established the processes / activities that should be carried out in case
p.(None): that an adverse event occurs in order to ensure timely and adequate medical attention to the subjects
p.(None): participants.
p.(None): Research Product:
p.(None): The handling of the research product must be under the responsibility of a qualified professional
p.(None): (Pharmaceutical Chemist), according to what is established for the management of a Pharmaceutical Service in the regulations
p.(None): National in force.
p.(None): Among its processes / activities is the reception, storage, accounting, informed dispensation, destruction and / or
...

p.(None): During the storage process, the Pharmaceutical Chemist is responsible for monitoring the conditions of
p.(None): Storage of research products, is also responsible for ensuring the control of dates
p.(None): of expiration of these products to avoid expiring expired medications to research subjects.
p.(None): As stated in the Colombian regulations for the management of expired medication or with
p.(None): Obvious problems in terms of quality or that by prior authorization of the sponsor must be removed, must
p.(None): There is a separate and identified storage area.
p.(None): With respect to the return and / or destruction of the investigational drug, a
p.(None): Process implemented in which records of this activity are kept. In cases that are returned
p.(None): the medicine to the sponsor or sent to another institution for its destruction, is the responsibility of the Center of
p.(None): investigation require a copy of this process, which should rest in the file where control of the
p.(None): medicine guaranteeing the management of the inventory of the product under investigation in a clear and reliable way.
p.(None): For the latter case, databases may be developed where at least the following are specified
p.(None): fields: medication identification code, expiration date, lot number, date received in
p.(None): the center, date of dispensation, data of the research subject, date of return of medications to
p.(None): center (if applicable) and return date to the sponsor or CRO (Contract Research Organization) (if applicable).
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 10 of 11
p.(None): It is important to remember that it is the responsibility of the Principal Investigator and / or the Pharmaceutical Chemist to carry out
p.(None): follow up to treatment adherence.
p.(None): Coordination of clinical studies
p.(None): Within the institution there must be a specific site where the administrative part of the
p.(None): research study, which must have the infrastructure, space, technical capacity and human resources
p.(None): competent, according to the number, complexity and difficulty of the research studies carried out
p.(None): out in the IPS. This site must keep the privacy, confidentiality and security required by the
p.(None): Good Clinical Practices, therefore it cannot be shared with another area of the Research Center.
p.(None): The research file must contain the minimum documents set forth in Resolution 2378 of 2008, must
p.(None): be in a suitable space according to the number of studies carried out in the
p.(None): institution, which guarantees the custody and integrity of the documents. This must be separated from the care area and
p.(None): from any other administrative area of the institution including the research area, but at
p.(None): scope of the research team, finally it must be locked up so that confidentiality is kept
p.(None): Own study.
p.(None): In the case of closed studies you must have a defined space. Its storage will be at least two (2) years
p.(None): after approval of the marketing application or until at least two years have elapsed since the
p.(None): formal suspension of the clinical development of the research product.
p.(None): SPONSOR:
...

p.(None): invimabpc@invima.gov.co in a maximum time of 15 working days since the Sponsor / CRO has knowledge.
p.(None): There must be a contractual agreement between the sponsor and the institution / researcher, which must be signed by
p.(None): the legal representative of each of the parties. The document must include aspects such as: term of
p.(None): contract, budget and method of payment, responsibilities of the parties, confidentiality, insurance or
p.(None): compensation, conflict of interest, measures or penalties in case of non-compliance, retention time of the
p.(None): archive, among others.
p.(None): Likewise, the agreements made between other parties involved for the development of the clinical study
p.(None): must be in writing, between the institution and contracted services such as the ethics committee, laboratory
p.(None): clinical or other services.
p.(None): It is the responsibility of the Sponsor to submit any changes made in the study of Invima to the approval of the Invima
p.(None): investigation.
p.(None): 7. ANNEXES
p.(None): • Format of Presentation and Evaluation of Research Protocols ASS-RSA-FM055
p.(None): Guide for the presentation of research protocols ASS-RSA-GU030
p.(None): Format Checklist for receiving documents related to research protocols ASS-
p.(None): RSA-FM046
p.(None): • Format for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): ASS-RSA-FM047 research protocols
p.(None): Guide for the presentation of amendments, new centers, new researchers and informed consents of
p.(None): research protocols ASS-RSA-GU031
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 11 of 11
p.(None): • Format for Notification of Closure of Clinical Studies (Protocols) ASS-RSA-FM049
p.(None): Guide for Notification of Closure of Clinical Studies (Protocols) ASS-RSA-GU033
p.(None): • Format for Presentation and Evaluation of New Requests for Importing Supplies for
p.(None): Research protocols ASS-RSA-FM052
p.(None): Presentation and Evaluation Format for New Applications for the Export of Biological Samples for
p.(None): ASS-RSA-FM053 Research protocols
p.(None): Guide for the Presentation of New Requests for Importing Supplies and Exporting Samples
p.(None): Biological for research protocols ASS-RSA-GU036
p.(None): • Format Annual Report of Research Projects ASS-RSA-FM063
p.(None): Guide for the completion of the annual research project format ASS-RSA-GU041
p.(None): • Presentation format and evaluation of modifications to the ASS-RSA-FM054 researcher's manual
p.(None): Guide for the Presentation and Evaluation of Modifications to the ASS-RSA-GU037 Investigator Manual
p.(None): • Format for the presentation of studies of drug stability in research ASS-RSA-FM088
p.(None): Guide for the Presentation of Research Stability Studies in Research ASS-RSA-GU055
p.(None): • Guide for Research Ethics Committees ASS-RSA-GU040
p.(None): • Guide for Medicines and Clinical Research Supplies ASS-RSA-GU045
p.(None): • Guide for the completion of the adverse event report formats in research protocols ASS-
p.(None): RSA-GU057
p.(None): • Format deviation notification in clinical trials ASS-RSA-FM101
...

Health / healthy volunteers

Searching for indicator healthy volunteers:

Searching for indicator age:

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p.(None): regulatory submission of sanitary authorization.
p.(None): • Studies in patients where the drug is directed.
p.(None): • Efficacy and safety data + number of patients.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions (eg insufficiency
p.(None): renal).
p.(None): • Provide very important information for IPP and labeling in general.
p.(None): 1 Order SAS / 3470/2009, of December 16, by which the guidelines on post-authorization type studies are published
p.(None): Observatory for medicines for human use., December 25, 2009.
p.(None): 2 Ramirez R. and Soto N. Preclinical and Clinical Studies. Executive Directorate of Product Authorization and
p.(None): Establishments COFEPRIS Mexico
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 2 of 11
p.(None): Phase III b:
p.(None): • Clinical studies that are performed after regulatory submission and related dossiers, but before
p.(None): Be approved and released.
p.(None): • Quality of life studies.
p.(None): Phase IV with intervention:
p.(None): • Trials conducted after drug launch
p.(None): • Provides additional efficacy and safety data
p.(None): • Different formulations, doses, duration of Tx, interactions with others, and comparisons.
p.(None): • Population groups (age, race, gender)
p.(None): • Critical to collect security data.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions
p.(None): Critical or very serious deviations: procedures or practices that negatively affect rights, security or
p.(None): the well-being of the subjects or the quality and integrity of the data.3
p.(None): Major or serious deviations: procedures or practices that could negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data.3
p.(None): Minor deviations: procedures or practices that are not expected to negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data. 3
p.(None): Amendment to the project: Written description of change (s) or formal clarification of a project4.
p.(None): Relevant Amendment: Those modifications of the protocol that may affect the safety of the
p.(None): subjects of study or of modifying the interpretation of the scientific evidence that supports the development of the study
p.(None): or are significant from any other point of view that affect the benefit / risk balance for
p.(None): the participating subjects5.
p.(None): Amendment Not relevant: All modifications to the protocol that do not affect the security of
p.(None): the subjects of studies, do not modify the interpretation of the scientific evidence that supports the development of
p.(None): essay and are not significant from any other point of view, which affect the balance
p.(None): benefit / risk for participating subjects.5
...

Searching for indicator race:

Searching for indicator minor:

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p.(None): Observatory for medicines for human use., December 25, 2009.
p.(None): 2 Ramirez R. and Soto N. Preclinical and Clinical Studies. Executive Directorate of Product Authorization and
p.(None): Establishments COFEPRIS Mexico
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 2 of 11
p.(None): Phase III b:
p.(None): • Clinical studies that are performed after regulatory submission and related dossiers, but before
p.(None): Be approved and released.
p.(None): • Quality of life studies.
p.(None): Phase IV with intervention:
p.(None): • Trials conducted after drug launch
p.(None): • Provides additional efficacy and safety data
p.(None): • Different formulations, doses, duration of Tx, interactions with others, and comparisons.
p.(None): • Population groups (age, race, gender)
p.(None): • Critical to collect security data.
p.(None): • Controlled and uncontrolled studies, groups of patients with special conditions
p.(None): Critical or very serious deviations: procedures or practices that negatively affect rights, security or
p.(None): the well-being of the subjects or the quality and integrity of the data.3
p.(None): Major or serious deviations: procedures or practices that could negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data.3
p.(None): Minor deviations: procedures or practices that are not expected to negatively affect rights,
p.(None): the safety or well-being of the subjects or the quality and integrity of the data. 3
p.(None): Amendment to the project: Written description of change (s) or formal clarification of a project4.
p.(None): Relevant Amendment: Those modifications of the protocol that may affect the safety of the
p.(None): subjects of study or of modifying the interpretation of the scientific evidence that supports the development of the study
p.(None): or are significant from any other point of view that affect the benefit / risk balance for
p.(None): the participating subjects5.
p.(None): Amendment Not relevant: All modifications to the protocol that do not affect the security of
p.(None): the subjects of studies, do not modify the interpretation of the scientific evidence that supports the development of
p.(None): essay and are not significant from any other point of view, which affect the balance
p.(None): benefit / risk for participating subjects.5
p.(None): Sponsor2: Individual, company, institution or organization responsible for initiating, administering / controlling and / or
p.(None): Fund a clinical study. This function can be performed by a corporation or agency outside the institution
p.(None): or by the researcher or hospital institution.
p.(None): 4. GUIDELINES FOR THE INITIAL PRESENTATION OF RESEARCH PROTOCOLS FOR THEIR EVALUATION
p.(None): According to Resolution 2378 of 2008 and 3823 of 1997, sponsors have the obligation to
p.(None): submit for approval by the Invima (Directorate of Medicines and Biological Products) the protocols of
p.(None): research with medicines carried out in Colombia between Phase I and Phase IV (with intervention)
...

p.(None): Registered to the sponsor through the Data Collection Notebook (Case Report Forms - CRF).
p.(None): • The inclusion of participating subjects should be done according to the research protocol, maintaining the
p.(None): confidentiality
p.(None): • All medical decisions must be in charge of a medical professional with scientific competence
p.(None): adequate care.
p.(None): • Any document delivered to the participating subject, such as recruitment announcements, clinical study material
p.(None): among others, they must have been previously evaluated according to the confidentiality parameters and
p.(None): Well-being with the subject.
p.(None): • Informed consent and / or informed consent, regardless of type (general, genetic, etc.), must be
p.(None): reviewed and approved by the Research Ethics Committee, must comply with current regulations and must be
p.(None): applied only by the IP or IS, who fully knows the clinical research protocol and the specialty
p.(None): of the same. On the other hand it must be done in a suitable place for reading, where the possible participant subject
p.(None): I can read it calmly without time pressures. This must be signed, accepted and understood by
p.(None): part of the participant before starting any procedure and must be supported in the document
p.(None): main source that is the medical history.
p.(None): • In order to fully guarantee the understanding of informed consent by the
p.(None): participants, mechanisms should be sought to assess the ability to understand and be
p.(None): Documented supported.
p.(None): • It should be clarified that in the case that the participating subject is a minor, it must be
p.(None): apply informed consent according to current regulations and consent
p.(None): informed to the responsible adult.
p.(None): Research Team:
p.(None): This is responsible for carrying out the development of the clinical study protocol in the research center,
p.(None): led by the principal investigator and made up of health professionals according to the characteristics of
p.(None): Each study The minimum members that it must contain are:
p.(None): • Principal investigator (IP): He is responsible for the research protocol he assumes, so
p.(None): both is responsible for the entire research team, who may delegate functions according to
p.(None): The suitability of each professional. You must have full knowledge of the protocol, methodology, background, driving,
p.(None): file and all aspects that have to do with the clinical research study and therefore has the
p.(None): ability to support an audit or monitoring visit.
p.(None): • Secondary researcher (IS): Is the person in which the researcher delegates specific clinical or clinical functions.
p.(None): procedure in the research study. It may be one or more secondary researchers.
p.(None): • Research coordinator: The research coordinator must be a professional in the area of health,
p.(None): delegate to handle the administrative aspects of the study. You must have the experience and suitability in
p.(None): research evaluated and defined by the research ethics committee. You can carry out several studies of
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): of the deviations should be defined whether or not it affects the research subject and generate corrective measures
p.(None): or depending on the severity of an improvement plan, which must be verified by the ethics committee in
p.(None): audit or other monitoring mechanism.
p.(None): As established by the research ethics committee and the Invima, the research center must
p.(None): make periodic, annual and final reports of each protocol in clinical research, which must be submitted
p.(None): to the Ethics Committee and the sponsor to consolidate it and send a final report of the study to Invima.
p.(None): The researcher must have available for review all records, correspondences, budget and
p.(None): other documents submitted and approved by the Ethics Committee, which may be subject to
p.(None): audit by the competent authorities and by the Ethics Committee when required.
p.(None): The ethics committee must verify that the policy is in force, which covers the adverse events of the study,
p.(None): compensation in case of death and you must also verify the accessibility of said policy, you must also verify
p.(None): the processes for the attention of the adverse events of the participating subjects, while accessing
p.(None): The insurance policy.
p.(None): Note: The Ethics Committee is the highest authority at the research site, however the principal investigator
p.(None): You can use the resource to inform the Invima of any observations or inconsistencies generated from the
p.(None): ethics committee in its approvals according to current regulations.
p.(None): Adverse events:
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To see the controlled document enter https://www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE
p.(None): SANITARY RECORDS AND ASSOCIATED PROCEDURES
p.(None): GUIDE FOR THE EVALUATION AND MONITORING OF RESEARCH PROTOCOLS
p.(None): Code: ASS-RSA-GU039 Version: 03 Issue Date: 06/07/2018
p.(None): Page 9 of 11
p.(None): Adverse events that are generated in the development of clinical research protocols should be reported as
p.(None): according to the regulations in force to the sponsor and / or regulatory agency in the corresponding formats according to the
p.(None): Guide for the completion of the adverse event report formats in ASS-RSA- research protocols
p.(None): GU057. On the other hand these must be registered in the adverse event report formats of the protocol of
p.(None): corresponding investigation.
p.(None): The principal investigator according to his knowledge, criteria, competence and experience within the
p.(None): Research study and / or with the support of the research team professionals should determine the
p.(None): causality of the adverse event. Similarly, within the analysis performed by the ethics committee, you can qualify
p.(None): to the adverse event differently.
p.(None): The research center must have established the processes / activities that should be carried out in case
p.(None): that an adverse event occurs in order to ensure timely and adequate medical attention to the subjects
...

Orphaned Trigger Words

p.(None): research protocols ASS-RSA-GU031
p.(None): • Stability Studies: The Format for the presentation of studies of
p.(None): stability of investigational drugs ASS-RSA-FM088 according to the Guide for the presentation of
p.(None): stability studies of research drugs ASS-RSA-GU055
p.(None): • New requests for Import of Supplies and Export of Biological Samples:
p.(None): fill out the presentation and evaluation format for new import requests for supplies for
p.(None): ASS-RSA-FM052 research protocols and Presentation and evaluation format for new export applications
p.(None): of biological samples for research protocols ASS-RSA-FM053 according to the Guide for
p.(None): presentation of new requests for import of supplies and export of biological samples for protocols
p.(None): ASS-RSA-GU036
p.(None): • Modifications to the Investigator Manual: The Presentation and Evaluation Format of
p.(None): modifications to the ASS-RSA-FM054 researcher's manual according to the Presentation Guide and
p.(None): Evaluation of modifications to the researcher's manual ASS-RSA-GU037.
p.(None): • Annual Report: The Annual Report of Research Projects FormatASS-RSA-FM063 must be completed in accordance
p.(None): to the Guide for the Diligenciamiento of the Annual Format of Projects of Investigation ASS-RSA-GU041
p.(None): • Protocol Closure: The format for notification of closure of clinical studies (protocols) must be completed.
p.(None): ASS-RSA-FM049 according to the Guide for notification of closure of clinical studies (protocols) ASS-RSA- GU033
p.(None): 6.2 Monitoring of research protocols: It will be carried out through visits to research centers that are
p.(None): developing the monitoring protocol. In this type of visits the status of a clinical study is verified in a
p.(None): research center, where the selection process, informed consent, management of
p.(None): the data (collection, registration and transcription), the management of the investigational medication, the
p.(None): current documentation approved by the Invima, the necessary documentation for the development of the clinical study and the
p.(None): monitoring of the protocol by the research ethics committee, among other things.
p.(None): Follow-up visits to the research protocol are made each time the Invima
p.(None): consider necessary and without prior notice. These visits are made in accordance with the provisions of paragraph 1,
p.(None): Article 4 of Resolution 2378 of 2008.
p.(None): Below are some guidelines for conducting a clinical study protocol within a Center for
p.(None): Research, which can be evaluated in follow-up visits.
p.(None): • The development of a clinical study in the country cannot begin until a concept of
p.(None): approval by Invima.
p.(None): • The research center must have a manual where all aspects are contemplated
p.(None): general operations about the investigation procedure. This manual must be approved by the representative
p.(None): legal of the institution and be aligned to its quality management system. In addition, a
p.(None): manual of functions and / or responsibilities of the research team and have documented the policy of
p.(None): conflicts of interest and confidentiality policy.
p.(None): • Each institution has the responsibility of verifying by means of a documented procedure, the supports of the
p.(None): Resumes of researchers and other members of the research team, including validation of the
p.(None): Information from undergraduate and graduate studies.
p.(None): • The clinical study must be conducted in accordance with current regulations and as defined by the Ethics Committee in
p.(None): Research, therefore should have the right amount of human resources, infrastructure and technical tools.
p.(None): • The medical history must be unified, according to Resolution 1995 of 1999; is the document
p.(None): source par excellence and must record all data related to the medical act, the application of ...

p.(None): Sample processing required by the clinical studies protocol.
p.(None): The research team must have designed a work plan that includes the functions and times that
p.(None): must comply according to the processes carried out in each of the protocols under its responsibility,
p.(None): These same functions must be registered in the format of responsibilities (log responsability) of each study.
p.(None): The work plan is subject to verification in follow-up visits to protocols and to the
p.(None): Certification in Good Clinical Practices by Invima. On the other hand the Principal Investigator
p.(None): As leader of the research team, you should review and monitor the processes performed by each member.
p.(None): Every member of the research team must be trained in Good Clinical Practices through a face-to-face course
p.(None): or virtual, which must include training in national regulations in force in research, before
p.(None): come into contact with the research subject.
p.(None): The research team must have constant training according to the needs it deems relevant in
p.(None): the investigation process (BPC) or the protocols that are being carried out.
p.(None): The research team must guarantee the adherence of the participating subject to the research protocol, through
p.(None): of different internally created procedures. These procedures must be previously approved by the committee
p.(None): of ethics
p.(None): Ethical Regulations:
p.(None): The Ethics Committee must have a procedure for receiving, evaluating, analyzing, socializing, monitoring the
p.(None): decisions and approvals made regarding research protocols.
p.(None): The Research Center cannot initiate a clinical study protocol without its approval.
p.(None): initially by its ethics committee and it has the approval of the Invima. It is considered the beginning of a
p.(None): clinical study, when the first research subject is included at the time of pre-selection.
p.(None): It is the responsibility of the Research Center to submit for approval of the Research Ethics Committee
p.(None): any changes made in the research study and report any deviation that occurs during the
p.(None): Conduction of the study. The ethics committee has the obligation to receive the information, analyze it and
p.(None): To issue a concept, all these processes must be documented in the archives of the ethics committee. For that matter
p.(None): of the deviations should be defined whether or not it affects the research subject and generate corrective measures
p.(None): or depending on the severity of an improvement plan, which must be verified by the ethics committee in
p.(None): audit or other monitoring mechanism.
p.(None): As established by the research ethics committee and the Invima, the research center must
p.(None): make periodic, annual and final reports of each protocol in clinical research, which must be submitted
p.(None): to the Ethics Committee and the sponsor to consolidate it and send a final report of the study to Invima.
p.(None): The researcher must have available for review all records, correspondences, budget and
p.(None): other documents submitted and approved by the Ethics Committee, which may be subject to
p.(None): audit by the competent authorities and by the Ethics Committee when required.
p.(None): The ethics committee must verify that the policy is in force, which covers the adverse events of the study,
p.(None): compensation in case of death and you must also verify the accessibility of said policy, you must also verify
p.(None): the processes for the attention of the adverse events of the participating subjects, while accessing
p.(None): The insurance policy. ...

Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
age	Age
authority	Relationship to Authority
drug	Drug Usage
health	Health
healthy volunteers	healthy volunteers
minor	Youth/Minors
race	Racial Minority

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers

Trigger Words

capacity

consent

ethics

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	drug	10
Health	HIV/AIDS	HIV	1
Health	Health	health	15
Health	healthy volunteers	healthy volunteers	1
Social	Age	age	1
Social	Racial Minority	race	1
Social	Youth/Minors	minor	2
General/Other	Relationship to Authority	authority	1

Policy on Ethical Research, Bioethics, and Scientific Integrity

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Drug Usage

Health / HIV/AIDS

Health / Health

Health / healthy volunteers

Social / Age

Social / Racial Minority

Social / Youth/Minors

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input