0A4F4F9BD490A749D5437F821CF06DF1
ABC Good Clinical Practice
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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 / political affiliation
Searching for indicator party:
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p.000019: Chairman of the Research Ethics Committee and the director of the entity's clinical laboratory.
p.000019: What other aspects should be taken into account when requesting the evaluation visit?
p.000019: 13.1 It is important to note that the evaluation process is divided into two phases:
p.000019: • In the first, a selection visit of projects under evaluation is carried out.
p.000019: • The second may consist of one or more visits where the compliance with the
p.000019: requirements demanded in the standard:
p.000019: twenty
p.000019: PHASE 1
p.000019: 1. START OF THE OPENING MEETING
p.000019: Between evaluator and delegate by the Institution
p.000019: 2. REVIEW AND REGISTRATION OF PROJECTS
p.000019: Last 12 months
p.000019: 3. RANDOM SELECTION OF PROJECTS
p.000019: 10% of projects or at least 2 projects
p.000019: PHASE 2
p.000019: 1. Evaluation to the Ethics Committee
p.000019: 4. Evaluation to Clinical Laboratory
p.000019: INVIMA evaluation visit
p.000019: 2. Evaluation to Researchers
p.000019: 3. Evaluation to Sponsor
p.000019: 13.2 Final report of results: At the end of each evaluation process with visits to stakeholders
p.000019: participants, the evaluation group generates a "visit record": document describing the findings of the
p.000019: evaluation.
p.000019: The analysis of this information determines the concept of compliance with requirements and the consequent
p.000019: granting of the Certificate in Good Clinical Practice.
p.000019: twenty-one
p.000019: Glossary
p.000019: Direct access: Authorization to examine, analyze, verify and reproduce any record and report that
p.000019: is important to the evaluation of a clinical study. Either party (for example, authorities and auditors
p.000019: of the sponsor) who has direct access, must take all reasonable precautions, within the provisions of
p.000019: the applicable regulatory requirements, to maintain the confidentiality of the identity of the subjects and
p.000019: of the information owned by the sponsor.
p.000019: Quality assurance: All the planned and systematic actions that are established to
p.000019: ensure that the study is being conducted and that data is generated, documented (recorded), and
p.000019: reported in compliance with Good Clinical Practice (PCB) and the regulations that apply to them.
p.000019: Random assignment: It is the process of assigning study subjects to treatment or control groups,
p.000019: using chance to determine subjects in order to reduce bias.
p.000019: Audit: It is a systematic and independent examination of the activities and documents related to the study,
p.000019: to determine if the activities were evaluated and the data was recorded, analyzed and
p.000019: Accurately reported according to the project, to the Sponsor's Standard Operating Procedures
p.000019: (Poes), to Good Clinical Practices and applicable regulatory requirements.
p.000019: Auditing Study Data: A Comparison of the Source Data and Records Associated with the Report
p.000019: intermediate or final, to determine if said data were accurately reported, establish whether the
p.000019: studies were carried out according to the project and the applicable PCBs, obtaining additional information not provided in the
p.000019: report and establish whether procedures were used to obtain the data that could
p.000019: invalidate them.
p.000019: Biosecurity in the clinical laboratory: It is the set of rules and procedures that guarantee the control of factors
...
Political / vulnerable
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p.000006: evaluation of institutions.
p.000006: We hope that the content of this publication will become a valuable source of consultation and an instrument
p.000006: to advance in the proper implementation and certification of Good Clinical Practices, for the benefit of
p.000006: health and quality of life of Colombians.
p.000006: Jairo Céspedes Camacho
p.000006: Managing Director
p.000007: 7
p.000007: What is a Good Clinical Practice?
p.000007: It is an international standard of ethical and scientific quality for the design, conduct, realization,
p.000007: monitoring, auditing, recording, analysis and reporting of clinical studies that involve the development of
p.000007: participation of human beings. This model ensures that the data and reported results are credible and
p.000007: accurate, and that the rights, integrity and confidentiality of the study subjects are protected.
p.000007: How were the Good Clinical Practices born?
p.000007: In 1995 the World Health Organization, based on regulations established in some
p.000007: countries, developed the “Guide to Good Clinical Practice for research of pharmaceutical products in human beings
p.000007: human ”, in order to establish standards applicable worldwide.
p.000007: In 2004, the World Health Organization formed a working group dedicated to studying in
p.000007: depth of the regulatory issue in Good Clinical Practice and Ethics. This working group formulated a series of
p.000007: recommendations, among which are:
p.000007: • The adoption of Good Clinical Practice guidelines for all clinical studies
p.000007: • The requirement of informed consent documents: those in which patients
p.000007: voluntarily accept their participation in medical studies (especially in vulnerable populations) and to
p.000007: obtaining biological samples in genetic studies.
p.000007: In the Americas, under the leadership of the Pan American Health Organization, work has been ongoing
p.000007: since 1999 with the initial formation of a regional working group charged with promoting Good
p.000007: Clinical Practices and provide nations with the respective implementation guides.
p.000009: 9
p.000009: Regional diagnostics have been carried out for a subsequent harmonization of regulations and
p.000009: The countries have accepted the recommendations of the working group, especially in relation to the
p.000009: Ethics Committees and informed consent.
p.000009: In 2005, the Technical Working Groups delegated by the countries that make up the Pan American Harmonization Network
p.000009: of the Pharmaceutical Regulation, REDPARF, prepared the document Good Clinical Practices: document of the
p.000009: Americas. This was sent to Colombia in March of the same year.
p.000009: What is the legal basis for the implementation of Good Clinical Practice in Colombia?
p.000009: The Ministry of Social Protection issued Resolution 2378 of June 27, 2008, through
p.000009: which were officially adopted and with mandatory character the Good Clinical Practices for
p.000009: institutions that conduct research with medicines in human beings in Colombia.
p.000009: Who is responsible for evaluating drug research protocols in humans?
p.000009: The group of experts that make up the Specialized Chamber of Medicines and Biological Products of
p.000009: The INVIMA Review Commission is in charge of evaluating the scientific, methodological and ethical aspects of
...
Health / Drug Usage
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p.000005: Good Clinical Practices
p.000005: MINISTRY OF SOCIAL PROTECTION
p.000005: National Institute for Food and Drug Surveillance - INVIMA
p.000005: Managing Director
p.000005: Jairo Céspedes Camacho
p.000005: Deputy Director of Health Records
p.000005: Clara Isabel Rodríguez Serrano
p.000005: Deputy Director of Medicines and Biological Products
p.000005: Martha Cecilia Rodríguez Ramírez
p.000005: Deputy Director of Health Supplies and Miscellaneous Products
p.000005: Ana Graciela Criado Aussant
p.000005: Deputy Director of Food and Alcoholic Beverages
p.000005: Laura Pasculli Henao
p.000005: General Secretary
p.000005: Perla Inés Llinás Álvarez
p.000005: Head of the Legal Advisory Office
p.000005: Aura Yineth Correa Child
p.000005: Head of the Planning, Informatics and Statistics Advisory Office
p.000005: Astreed Carolina Sierra Arias
p.000005: Head of Internal Control Office
p.000005: Norma Constanza García Ramírez
p.000005: Content Development Juana Tobos Otálora Paola Vitery Ortíz
p.000005: Adriana Vanegas Sánchez
p.000005: Editorial Coordination Teresa Huertas Molina Silvia Blanco Díaz
p.000005: Design and layout Bernardo Arias Blanco Monica Cabiativa Daza
p.000005: Print
p.000005: www.digitosydisenos.com
p.000005: Bogotá, D.C. 2009 ©
p.000005: Content
p.000005: INVIMA 5 Presentation
p.000005: Introduction 7
p.000005: 1. What is a Good Clinical Practice? 9
p.000005: 2. How were Good Clinical Practices born? 9
p.000005: 3. What is the legal basis for implementation
p.000005: of Good Clinical Practices in Colombia? 10
p.000005: 4. Who is in charge of evaluating the protocols
p.000005: research with drugs in humans? 10
p.000005: 5. Who participates in an investigation
p.000005: with medications in humans? eleven
p.000005: 6. What authority is it to verify
p.000005: compliance with Good Clinical Practices? 12
p.000005: 7. What is the certificate in Good Clinical Practice? 13
p.000005: 8. What is the scope of the certificate
p.000005: in Good Clinical Practice? 13
p.000005: 9. What are the main legal requirements that must be met in Good Clinical Practice and what role
p.000005: Does each member of the system play? 14
p.000005: 10. What are the roles and responsibilities
p.000005: from the main researchers? 17
p.000005: 11. What happens if a breach occurs
p.000005: of any of the requirements? 18
p.000005: 12. How to request an evaluation visit to qualify
p.000005: for the Certification in Good Clinical Practices? 19
p.000005: 13. What other aspects should be taken into account
p.000005: when requesting the evaluation visit? twenty
p.000005: 14. Glossary 22
p.000005: 15. Index of tables of the standard (Resolution 2378 of 2008) 28
p.000005: INVIMA Presentation
p.000005: The National Institute for Food and Drug Surveillance INVIMA is a public establishment of the
p.000005: national order, attached to the Ministry of Social Protection, which as Colombian Health Agency
p.000005: implements policies in the field of health surveillance and quality control.
p.000005: The scope of its management involves products of vital importance to society such as: medicines,
p.000005: biological products, natural and homeopathic products, diagnostic reagents, devices and elements
p.000005: medical surgical and dental, processed foods, meats, packaged beverages, alcoholic beverages,
p.000005: cosmetics, condoms, toiletries, among others.
p.000005: INVIMA's mission is to guarantee public health in Colombia, exercising inspection, surveillance and
p.000005: sanitary control of a scientific technical nature on matters within its competence.
p.000005: In accordance, INVIMA has defined the north of its management on three fundamental axes: guaranteeing the
p.000005: public health in Colombia, contribute to raising the country's health status so that it is recognized at the
p.000005: international, and be a support in competitiveness.
p.000005: INVIMA's Technical and Scientific Character
p.000005: In the execution of health policies, INVIMA interacts with four national systems: System
p.000005: of Public Health, Environmental Health System, System of Sanitary and Phytosanitary Measures and System of Science and
p.000005: Technology.
p.000005: The technical and scientific nature of INVIMA is supported by the Institute's interaction with agencies
p.000005: health organizations, organizations of the academic community, scientific associations and associations of
p.000005: professionals; and inside it is based on the conformation and full functioning of the six Specialized Rooms
...
p.000007: • The requirement of informed consent documents: those in which patients
p.000007: voluntarily accept their participation in medical studies (especially in vulnerable populations) and to
p.000007: obtaining biological samples in genetic studies.
p.000007: In the Americas, under the leadership of the Pan American Health Organization, work has been ongoing
p.000007: since 1999 with the initial formation of a regional working group charged with promoting Good
p.000007: Clinical Practices and provide nations with the respective implementation guides.
p.000009: 9
p.000009: Regional diagnostics have been carried out for a subsequent harmonization of regulations and
p.000009: The countries have accepted the recommendations of the working group, especially in relation to the
p.000009: Ethics Committees and informed consent.
p.000009: In 2005, the Technical Working Groups delegated by the countries that make up the Pan American Harmonization Network
p.000009: of the Pharmaceutical Regulation, REDPARF, prepared the document Good Clinical Practices: document of the
p.000009: Americas. This was sent to Colombia in March of the same year.
p.000009: What is the legal basis for the implementation of Good Clinical Practice in Colombia?
p.000009: The Ministry of Social Protection issued Resolution 2378 of June 27, 2008, through
p.000009: which were officially adopted and with mandatory character the Good Clinical Practices for
p.000009: institutions that conduct research with medicines in human beings in Colombia.
p.000009: Who is responsible for evaluating drug research protocols in humans?
p.000009: The group of experts that make up the Specialized Chamber of Medicines and Biological Products of
p.000009: The INVIMA Review Commission is in charge of evaluating the scientific, methodological and ethical aspects of
p.000009: research protocols with drugs in humans and give a "favorable" or "not favorable" concept of the
p.000009: themselves.
p.000009: Once the concept of the Specialized Room has been issued, which is published through the Act on the website
p.000009: www.invima.gov.co, the INVIMA Subdirectorate for Medicines and Biological Products welcomes the concept and
p.000009: "Approves" or "denies" the development of the research protocol.
p.000010: 10
p.000010: Who is involved in a drug research in humans?
p.000010: When a study is undertaken in which the safety and efficacy of a drug will be evaluated and
p.000010: involves human beings as part of it, various actors with specific responsibilities are integrated
p.000010: within the process:
p.000010: • The Institutional Ethics Committee: It is an independent body, made up of a professional group
p.000010: multidisciplinary with critical capacity that watches over the integrity of the participating subjects.
p.000010: • Health Services Provider Institution: This is where the research process takes place.
p.000010: This institution must have the certificate of the “Unique Enabling System”.
p.000010: • The principal investigator: He is the expert doctor in the matters related to the investigation matter, and is
p.000010: who conducts the study.
p.000010: • The clinical laboratory: It is in charge of taking, processing and packaging the samples related to the
p.000010: study.
p.000010: • The sponsor: It is the institution or organization that makes the contributions to finance the study.
p.000010: • The impartial witness: Person (s) who attend the procedure of declaration of informed consent and with
p.000010: Your signature attests that sufficient and clear information has been given about the study's risks and benefits. The witness
p.000010: impartial cannot have any
p.000010: link with the other actors in the investigation.
p.000010: • Participating subjects: People who voluntarily and informedly participate in the process of
p.000010: investigation.
p.000010: eleven
p.000010: SPONSOR
p.000010: Investigator Financer
p.000010: RESEARCH PRODUCT
p.000010: Pharmaceutical form
p.000010: CLINICAL STUDY
p.000010: CENTER WHERE THE STUDY IS CARRIED OUT - IPS
p.000010: Ethics Committee
p.000010: Institutional Independent
...
Searching for indicator substance:
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p.000022: humans involved in a study through, among other things, constant review, approval and review
p.000022: of the study project and amendments to the documentation and the informed consent of the subjects of the
p.000022: study.
p.000022: Independent Ethics Committee: Independent organization (a review board or institutional, regional committee,
p.000022: national or supranational), made up of medical / scientific professionals and non-medical / non-scientific members,
p.000022: whose responsibility is to ensure the protection of the rights, safety and well-being of human beings
p.000022: involved in a study and provide a public guarantee of that protection of the rights to
p.000022: through, among other aspects, the review and approval / favorable opinion of the study project, the
p.000022: capacity of researchers and the adequacy of the facilities, methods and material to be used when
p.000022: Obtain and document the informed consent of the study subjects.
p.000022: Confidential: Corresponds to information, reports or communications, property of the sponsor or the identity of a
p.000022: subject, which can only be disclosed to others who are authorized or to the health entity
p.000022: correspondent.
p.000022: 2. 3
p.000022: Comparator: A research or marketed product (eg, active control) or placebo
p.000022: (substance that, by itself lacking therapeutic action, produces some curative effect in the
p.000022: ill, if he receives it convinced that he really has such an action) often used in a study
p.000022: clinical.
p.000022: Informed consent: A process by which a subject voluntarily confirms their desire to
p.000022: participate in a particular study, after being informed about all aspects of it
p.000022: relevant and may affect your decision to participate. Informed consent is documented through the
p.000022: informed consent form, which must be signed and dated by the participant, two witnesses and the
p.000022: medical researcher.
p.000022: Quality Control (CC): The techniques and operational activities carried out within the insurance system of
p.000022: quality to verify that the quality requirements of related activities have been met
p.000022: with the study.
p.000022: Essential documents: Documents that individually and collectively allow an evaluation of the driving of a
p.000022: study and the quality of the general data.
p.000022: Source documents: Original documents, data and records (for example, hospital records, clinical sheets, notes
p.000022: laboratory reports, memoranda, subject diaries or evaluation checklists, records of delivery of the
p.000022: pharmacy, recorded data from automated instruments, certified copies or transcripts after
p.000022: verify that they are exact copies, microfiche, photographic negatives, magnetic media or microfilm,
p.000022: x-rays, subjects' records and records kept at the pharmacy in the laboratories and in the departments
p.000022: medical technicians involved in the clinical study).
p.000022: Project amendment: Written description of changes or formal clarification of a project.
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000024: safety and / or efficacy.
p.000024: Non-clinical study: Biomedical studies not performed in humans.
p.000024: Multicenter study: Clinical study conducted according to a single project but in more than one place and, therefore,
p.000024: performed by more than one researcher.
p.000024: Evaluator: Person designated by INVIMA or another entity in charge of executing the evaluation process,
p.000024: to carry out said procedure in one or more institutions.
p.000024: Adverse Event (AE): Any adverse medical occurrence in a patient or subject of a clinical investigation a
p.000024: who was administered a pharmaceutical product and who does not necessarily have a causal relationship with
p.000024: this treatment. Therefore, an adverse event (EA) can be any unfavorable sign and not
p.000024: intentional (including abnormal laboratory finding), symptom or disease temporarily associated with
p.000024: the use of a medicinal (research) product, whether or not related to it.
p.000024: Serious Adverse Event (EAS): Any adverse medical occurrence in a patient or subject of a clinical investigation a
p.000024: who was administered a pharmaceutical product and who does not necessarily have a causal relationship with this treatment.
p.000024: Therefore, an adverse event (EA) can be any unfavorable and unintended sign (including
p.000024: abnormal laboratory finding) symptom or disease temporarily associated with the use of a product
p.000024: medicinal (research), whether or not related to it, that at any dose:
p.000024: a) Results in death.
p.000024: b) Threatens life.
p.000024: c) Requires hospitalization of the patient or prolongation of the existing hospitalization.
p.000024: d) Results in persistent or significant disability / invalidity.
p.000024: Case Report Form (FRC): It is a printed, optical or electronic document designed to
p.000024: record all the information required in the project to be reported to the sponsor about each subject of the
p.000024: study.
p.000024: Committee Operational Guides (GOC): Detailed and written instructions to achieve uniformity in the
p.000024: execution of a specific function. Equivalent to the Standardized Operating Procedures Manual (MPOE).
p.000025: 25
p.000025: Inspection: The action of the health authorities or the Ministry of Social Protection to carry out
p.000025: an official review of documents, facilities, records and any other resources that the authorities
p.000025: consider that they are related to the clinical study and that they can be located at the site where the
p.000025: study, at the facilities of the sponsor, the Contract Research Organization (OIC), or other
p.000025: sites that the authorities consider appropriate.
p.000025: Health Services Provider Institution (IPS): For the purposes of this resolution, they are considered
p.000025: as such health service providers and professional practice groups that have infrastructure
p.000025: physical to provide health services.
p.000025: Researcher: Person responsible for conducting a clinical study at the institution. If a study is
p.000025: led by a group of individuals, the investigator is the responsible leader of the group and will be called an investigator
p.000025: principal.
p.000025: Investigator's Manual: Compilation of clinical and non-clinical data on the products of
p.000025: research that is relevant to the study of research products in humans.
p.000025: Standard Operating Procedures Manual (MPOE): Detailed written instructions to achieve
p.000025: uniformity in the execution of a specific function. Equivalent to the Written Operational Guides (GOC).
...
Health / Physically Ill
Searching for indicator sick:
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p.000005: • Sanctioning processes
p.000005: INVIMA in the Country
p.000005: INVIMA has placed eight Territorial Working Groups at the service of Colombians, which are being strengthened to
p.000005: consolidate the presence of the Institute in the Country, with the technical, scientific and administrative capacity to assume
p.000005: all your skills.
p.000005: The Territorial Working Groups of INVIMA and its host cities are:
p.000005: 1. Caribbean Coast 1 with headquarters in Barranquilla and coverage in Atlántico, Guajira, Magdalena and Cesar
p.000005: 2. Costa Caribe 2 with headquarters in Montería and coverage in Córdoba, Sucre, Bolívar and San Andrés, Providencia and Santa
p.000005: Katherine
p.000005: 3. Centro Oriente 1 with headquarters in Bucaramanga and coverage in Santander and Norte de Santander
p.000005: 4. Centro Oriente 2 with headquarters in Bogotá and coverage in Boyacá, Cundinamarca and Amazonas
p.000005: 5. Centro Oriente 3 based in Neiva
p.000005: and coverage in Tolima, Huila and Caquetá
p.000005: 6. Occidente 1 with headquarters in Medellín and coverage in Antioquia, Chocó, Caldas, Quindío and Risaralda
p.000005: 7. Occidente 2 with headquarters in Cali and coverage in Valle del Cauca, Cauca, Nariño and Putumayo
p.000005: 8. Orinoquía based in Villavicencio and coverage in
p.000005: Meta, Casanare, Arauca, Guaviare, Guainía, Vichada and Vaupés
p.000005: INVIMA carries out its management, always seeking the health and well-being of all Colombians.
p.000006: 6
p.000006: Introduction
p.000006: Scientific and technological advances in health represent a challenge in terms of
p.000006: health surveillance, especially when research for the development of new drugs
p.000006: They directly involve for their studies the participation of human beings, healthy and / or sick.
p.000006: As the National Health Agency, INVIMA is responsible for evaluating the protocols of the
p.000006: clinical investigations to be carried out in Colombia, follow up on the approved research course and
p.000006: issue the Certificate in Good Clinical Practices to the Healthcare Institutions that
p.000006: carry out or plan to start clinical investigations with medications in Colombia, all this with the
p.000006: fundamental objective of guaranteeing the protection of the rights, safety and well-being of the participating colombians
p.000006: in clinical research, and that the parameters for the development of the research keep the
p.000006: ethical and scientific guidelines that allow obtaining final reports of total quality and reliability.
p.000006: This ABC publication of Good Clinical Practices, aimed at those interested in developing research with
p.000006: medicines in humans, has been carried out by INVIMA in order to disclose in a language
p.000006: clear and simple, fundamental aspects such as the concept and historical context of Good Clinical Practice,
p.000006: steps to follow for the certification process and the main components involved in the process of
p.000006: evaluation of institutions.
p.000006: We hope that the content of this publication will become a valuable source of consultation and an instrument
p.000006: to advance in the proper implementation and certification of Good Clinical Practices, for the benefit of
p.000006: health and quality of life of Colombians.
p.000006: Jairo Céspedes Camacho
p.000006: Managing Director
p.000007: 7
p.000007: What is a Good Clinical Practice?
p.000007: It is an international standard of ethical and scientific quality for the design, conduct, realization,
...
Health / alcoholism
Searching for indicator alcoholic:
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p.000005: Good Clinical Practices
p.000005: MINISTRY OF SOCIAL PROTECTION
p.000005: National Institute for Food and Drug Surveillance - INVIMA
p.000005: Managing Director
p.000005: Jairo Céspedes Camacho
p.000005: Deputy Director of Health Records
p.000005: Clara Isabel Rodríguez Serrano
p.000005: Deputy Director of Medicines and Biological Products
p.000005: Martha Cecilia Rodríguez Ramírez
p.000005: Deputy Director of Health Supplies and Miscellaneous Products
p.000005: Ana Graciela Criado Aussant
p.000005: Deputy Director of Food and Alcoholic Beverages
p.000005: Laura Pasculli Henao
p.000005: General Secretary
p.000005: Perla Inés Llinás Álvarez
p.000005: Head of the Legal Advisory Office
p.000005: Aura Yineth Correa Child
p.000005: Head of the Planning, Informatics and Statistics Advisory Office
p.000005: Astreed Carolina Sierra Arias
p.000005: Head of Internal Control Office
p.000005: Norma Constanza García Ramírez
p.000005: Content Development Juana Tobos Otálora Paola Vitery Ortíz
p.000005: Adriana Vanegas Sánchez
p.000005: Editorial Coordination Teresa Huertas Molina Silvia Blanco Díaz
p.000005: Design and layout Bernardo Arias Blanco Monica Cabiativa Daza
p.000005: Print
p.000005: www.digitosydisenos.com
p.000005: Bogotá, D.C. 2009 ©
p.000005: Content
p.000005: INVIMA 5 Presentation
p.000005: Introduction 7
p.000005: 1. What is a Good Clinical Practice? 9
p.000005: 2. How were Good Clinical Practices born? 9
p.000005: 3. What is the legal basis for implementation
p.000005: of Good Clinical Practices in Colombia? 10
p.000005: 4. Who is in charge of evaluating the protocols
p.000005: research with drugs in humans? 10
p.000005: 5. Who participates in an investigation
p.000005: with medications in humans? eleven
p.000005: 6. What authority is it to verify
p.000005: compliance with Good Clinical Practices? 12
p.000005: 7. What is the certificate in Good Clinical Practice? 13
p.000005: 8. What is the scope of the certificate
p.000005: in Good Clinical Practice? 13
p.000005: 9. What are the main legal requirements that must be met in Good Clinical Practice and what role
p.000005: Does each member of the system play? 14
p.000005: 10. What are the roles and responsibilities
p.000005: from the main researchers? 17
p.000005: 11. What happens if a breach occurs
p.000005: of any of the requirements? 18
p.000005: 12. How to request an evaluation visit to qualify
p.000005: for the Certification in Good Clinical Practices? 19
p.000005: 13. What other aspects should be taken into account
p.000005: when requesting the evaluation visit? twenty
p.000005: 14. Glossary 22
p.000005: 15. Index of tables of the standard (Resolution 2378 of 2008) 28
p.000005: INVIMA Presentation
p.000005: The National Institute for Food and Drug Surveillance INVIMA is a public establishment of the
p.000005: national order, attached to the Ministry of Social Protection, which as Colombian Health Agency
p.000005: implements policies in the field of health surveillance and quality control.
p.000005: The scope of its management involves products of vital importance to society such as: medicines,
p.000005: biological products, natural and homeopathic products, diagnostic reagents, devices and elements
p.000005: medical surgical and dental, processed foods, meats, packaged beverages, alcoholic beverages,
p.000005: cosmetics, condoms, toiletries, among others.
p.000005: INVIMA's mission is to guarantee public health in Colombia, exercising inspection, surveillance and
p.000005: sanitary control of a scientific technical nature on matters within its competence.
p.000005: In accordance, INVIMA has defined the north of its management on three fundamental axes: guaranteeing the
p.000005: public health in Colombia, contribute to raising the country's health status so that it is recognized at the
p.000005: international, and be a support in competitiveness.
p.000005: INVIMA's Technical and Scientific Character
p.000005: In the execution of health policies, INVIMA interacts with four national systems: System
p.000005: of Public Health, Environmental Health System, System of Sanitary and Phytosanitary Measures and System of Science and
p.000005: Technology.
p.000005: The technical and scientific nature of INVIMA is supported by the Institute's interaction with agencies
p.000005: health organizations, organizations of the academic community, scientific associations and associations of
p.000005: professionals; and inside it is based on the conformation and full functioning of the six Specialized Rooms
p.000005: of the Review Commission (Medicines and Biological Products, Natural Products, Homeopathic Medicines,
p.000005: Food and Alcoholic Beverages, Medical Devices and Various Products, and In Vitro Diagnostic Reagents),
p.000005: in the specialization of the Missionary Subdirections and in the professional capacity of those who make up the teams of
p.000005: job.
p.000005: INVIMA's powers
p.000005: INVIMA develops its management as a Health Authority with the exercise of these powers
p.000005: fundamental:
p.000005: 5
p.000005: • Issuance of Sanitary Registries and Sanitary Notifications
p.000005: • Certification visits
p.000005: • Inspection, Surveillance and Control Actions
p.000005: • Pre and post marketing surveillance, and special programs
p.000005: • National Reference Laboratory
p.000005: • Regulatory harmonization in health matters
p.000005: • Knowledge Management and Applied Research
p.000005: • Training and Technical Assistance
p.000005: • Sanctioning processes
p.000005: INVIMA in the Country
p.000005: INVIMA has placed eight Territorial Working Groups at the service of Colombians, which are being strengthened to
p.000005: consolidate the presence of the Institute in the Country, with the technical, scientific and administrative capacity to assume
p.000005: all your skills.
p.000005: The Territorial Working Groups of INVIMA and its host cities are:
p.000005: 1. Caribbean Coast 1 with headquarters in Barranquilla and coverage in Atlántico, Guajira, Magdalena and Cesar
p.000005: 2. Costa Caribe 2 with headquarters in Montería and coverage in Córdoba, Sucre, Bolívar and San Andrés, Providencia and Santa
p.000005: Katherine
p.000005: 3. Centro Oriente 1 with headquarters in Bucaramanga and coverage in Santander and Norte de Santander
p.000005: 4. Centro Oriente 2 with headquarters in Bogotá and coverage in Boyacá, Cundinamarca and Amazonas
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000019: • The name of the sponsor or sponsors with whom they have developed these activities
p.000019: • The contact details of the institution's directors, the main researchers, the
p.000019: Chairman of the Research Ethics Committee and the director of the entity's clinical laboratory.
p.000019: What other aspects should be taken into account when requesting the evaluation visit?
p.000019: 13.1 It is important to note that the evaluation process is divided into two phases:
p.000019: • In the first, a selection visit of projects under evaluation is carried out.
p.000019: • The second may consist of one or more visits where the compliance with the
p.000019: requirements demanded in the standard:
p.000019: twenty
p.000019: PHASE 1
p.000019: 1. START OF THE OPENING MEETING
p.000019: Between evaluator and delegate by the Institution
p.000019: 2. REVIEW AND REGISTRATION OF PROJECTS
p.000019: Last 12 months
p.000019: 3. RANDOM SELECTION OF PROJECTS
p.000019: 10% of projects or at least 2 projects
p.000019: PHASE 2
p.000019: 1. Evaluation to the Ethics Committee
p.000019: 4. Evaluation to Clinical Laboratory
p.000019: INVIMA evaluation visit
p.000019: 2. Evaluation to Researchers
p.000019: 3. Evaluation to Sponsor
p.000019: 13.2 Final report of results: At the end of each evaluation process with visits to stakeholders
p.000019: participants, the evaluation group generates a "visit record": document describing the findings of the
p.000019: evaluation.
p.000019: The analysis of this information determines the concept of compliance with requirements and the consequent
p.000019: granting of the Certificate in Good Clinical Practice.
p.000019: twenty-one
p.000019: Glossary
p.000019: Direct access: Authorization to examine, analyze, verify and reproduce any record and report that
p.000019: is important to the evaluation of a clinical study. Either party (for example, authorities and auditors
p.000019: of the sponsor) who has direct access, must take all reasonable precautions, within the provisions of
p.000019: the applicable regulatory requirements, to maintain the confidentiality of the identity of the subjects and
p.000019: of the information owned by the sponsor.
p.000019: Quality assurance: All the planned and systematic actions that are established to
p.000019: ensure that the study is being conducted and that data is generated, documented (recorded), and
p.000019: reported in compliance with Good Clinical Practice (PCB) and the regulations that apply to them.
p.000019: Random assignment: It is the process of assigning study subjects to treatment or control groups,
p.000019: using chance to determine subjects in order to reduce bias.
p.000019: Audit: It is a systematic and independent examination of the activities and documents related to the study,
p.000019: to determine if the activities were evaluated and the data was recorded, analyzed and
p.000019: Accurately reported according to the project, to the Sponsor's Standard Operating Procedures
p.000019: (Poes), to Good Clinical Practices and applicable regulatory requirements.
p.000019: Auditing Study Data: A Comparison of the Source Data and Records Associated with the Report
p.000019: intermediate or final, to determine if said data were accurately reported, establish whether the
p.000019: studies were carried out according to the project and the applicable PCBs, obtaining additional information not provided in the
p.000019: report and establish whether procedures were used to obtain the data that could
p.000019: invalidate them.
p.000019: Biosecurity in the clinical laboratory: It is the set of rules and procedures that guarantee the control of factors
p.000019: of physical, chemical, biological and ergonomic risk that may affect the personnel linked to the clinical laboratory
p.000019: or to community members.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000022: study and the quality of the general data.
p.000022: Source documents: Original documents, data and records (for example, hospital records, clinical sheets, notes
p.000022: laboratory reports, memoranda, subject diaries or evaluation checklists, records of delivery of the
p.000022: pharmacy, recorded data from automated instruments, certified copies or transcripts after
p.000022: verify that they are exact copies, microfiche, photographic negatives, magnetic media or microfilm,
p.000022: x-rays, subjects' records and records kept at the pharmacy in the laboratories and in the departments
p.000022: medical technicians involved in the clinical study).
p.000022: Project amendment: Written description of changes or formal clarification of a project.
p.000022: Funding entity: Individual, company, institution or organization responsible for financing a clinical study.
p.000022: Biological specimen / sample: Tissues, liquids, or substances derived from the human body for the purpose of being
p.000022: analyzed and thus provide information for the diagnosis, prevention or treatment of any disease or
p.000022: for the evaluation of the health of a person.
p.000024: 24
p.000024: Clinical Study: Also called a clinical trial. It is any investigation that is made in beings
p.000024: humans with the intention of discovering or verifying the clinical, pharmacological and / or any other effects
p.000024: pharmacodynamic effect of investigational products, any adverse reaction and / or to study the
p.000024: absorption, distribution, metabolism and excretion of products under investigation, in order to check their
p.000024: safety and / or efficacy.
p.000024: Non-clinical study: Biomedical studies not performed in humans.
p.000024: Multicenter study: Clinical study conducted according to a single project but in more than one place and, therefore,
p.000024: performed by more than one researcher.
p.000024: Evaluator: Person designated by INVIMA or another entity in charge of executing the evaluation process,
p.000024: to carry out said procedure in one or more institutions.
p.000024: Adverse Event (AE): Any adverse medical occurrence in a patient or subject of a clinical investigation a
p.000024: who was administered a pharmaceutical product and who does not necessarily have a causal relationship with
p.000024: this treatment. Therefore, an adverse event (EA) can be any unfavorable sign and not
p.000024: intentional (including abnormal laboratory finding), symptom or disease temporarily associated with
p.000024: the use of a medicinal (research) product, whether or not related to it.
p.000024: Serious Adverse Event (EAS): Any adverse medical occurrence in a patient or subject of a clinical investigation a
p.000024: who was administered a pharmaceutical product and who does not necessarily have a causal relationship with this treatment.
p.000024: Therefore, an adverse event (EA) can be any unfavorable and unintended sign (including
p.000024: abnormal laboratory finding) symptom or disease temporarily associated with the use of a product
p.000024: medicinal (research), whether or not related to it, that at any dose:
p.000024: a) Results in death.
p.000024: b) Threatens life.
p.000024: c) Requires hospitalization of the patient or prolongation of the existing hospitalization.
p.000024: d) Results in persistent or significant disability / invalidity.
p.000024: Case Report Form (FRC): It is a printed, optical or electronic document designed to
p.000024: record all the information required in the project to be reported to the sponsor about each subject of the
p.000024: study.
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000022: multicenter.
p.000022: Institutional Ethics Committee (CEI): Independent organization made up of medical, scientific members
p.000022: and non-scientists, whose responsibility is to guarantee the protection of the rights, safety and well-being of
p.000022: humans involved in a study through, among other things, constant review, approval and review
p.000022: of the study project and amendments to the documentation and the informed consent of the subjects of the
p.000022: study.
p.000022: Independent Ethics Committee: Independent organization (a review board or institutional, regional committee,
p.000022: national or supranational), made up of medical / scientific professionals and non-medical / non-scientific members,
p.000022: whose responsibility is to ensure the protection of the rights, safety and well-being of human beings
p.000022: involved in a study and provide a public guarantee of that protection of the rights to
p.000022: through, among other aspects, the review and approval / favorable opinion of the study project, the
p.000022: capacity of researchers and the adequacy of the facilities, methods and material to be used when
p.000022: Obtain and document the informed consent of the study subjects.
p.000022: Confidential: Corresponds to information, reports or communications, property of the sponsor or the identity of a
p.000022: subject, which can only be disclosed to others who are authorized or to the health entity
p.000022: correspondent.
p.000022: 2. 3
p.000022: Comparator: A research or marketed product (eg, active control) or placebo
p.000022: (substance that, by itself lacking therapeutic action, produces some curative effect in the
p.000022: ill, if he receives it convinced that he really has such an action) often used in a study
p.000022: clinical.
p.000022: Informed consent: A process by which a subject voluntarily confirms their desire to
p.000022: participate in a particular study, after being informed about all aspects of it
p.000022: relevant and may affect your decision to participate. Informed consent is documented through the
p.000022: informed consent form, which must be signed and dated by the participant, two witnesses and the
p.000022: medical researcher.
p.000022: Quality Control (CC): The techniques and operational activities carried out within the insurance system of
p.000022: quality to verify that the quality requirements of related activities have been met
p.000022: with the study.
p.000022: Essential documents: Documents that individually and collectively allow an evaluation of the driving of a
p.000022: study and the quality of the general data.
p.000022: Source documents: Original documents, data and records (for example, hospital records, clinical sheets, notes
p.000022: laboratory reports, memoranda, subject diaries or evaluation checklists, records of delivery of the
p.000022: pharmacy, recorded data from automated instruments, certified copies or transcripts after
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000026: 26
p.000026: administered, delivered or used by the subject. The obligations of a sponsor-researcher include both the
p.000026: from a sponsor like a researcher.
p.000026: Standard Operating Procedures (SOPs): Detailed and written instructions to achieve uniformity in the
p.000026: execution of a specific function.
p.000026: Investigational product / medicine: Pharmaceutical form of an active ingredient or placebo that is being
p.000026: testing or using as a reference in a clinical study, including a product with an authorization from
p.000026: marketing when used or conditioned (formulated or packaged) in a manner different from that
p.000026: approved, or when used to obtain more information about a previously approved use.
p.000026: Project: Document that describes the objective or objectives, design, methodology, considerations
p.000026: statistics and organization of a study. Generally also provides background and rationale
p.000026: for the study, but these could be provided in other documents referenced in the project. East
p.000026: term includes its amendments.
p.000026: Audit Report: The sponsor's auditor's written evaluation of the results of the
p.000026: audit.
p.000026: Study subject: The individual participating in a clinical study, either as a recipient of the
p.000026: products under investigation or as a control.
p.000026: Quality system: It is defined as the group of actions and processes that aim to guarantee the quality of the
p.000026: results over time, immediately detect changes in the results due to failures in any of the
p.000026: components of the processes and monitor the different factors that can alter the precision of the results.
p.000026: Impartial Witness: Independent study person, who cannot be influenced in bad faith by staff
p.000026: involved in the investigation, who is present in the process of obtaining informed consent, if the
p.000026: subject or the representative of the subject legally accepted does not know how to read, and who is responsible for reading
p.000026: informed consent and any other written information provided to the subject or by the subject.
p.000027: 27
p.000027: Index of tables of the standard (Resolution 2378 of 2008)
p.000027: Chapter II
p.000027: Chapter III
p.000027: Chapter IV
p.000028: 28
p.000028: TABLE 1
p.000028: TABLE 2
p.000028: TABLE 3
p.000028: TABLE 4
p.000028: Table 1
p.000028: Table 2
p.000028: TABLE 5
p.000028: TABLE 6
p.000028: TABLE 7
p.000028: TABLE 8
p.000028: TABLE 9
p.000028: TABLE 10
p.000028: TABLE 11
p.000028: TABLE 12
p.000028: TABLE 13
p.000028: TABLE 14
p.000028: TABLE 15
p.000028: TABLE 16
p.000028: TABLE 17
p.000028: TABLE 18
p.000028: TABLE 19
p.000028: TABLE 20
p.000028: I II
p.000028: TABLE 1
p.000028: TABLE 2
p.000028: TABLE 3
p.000028: TABLE 4
p.000028: TABLE 5
p.000028: TABLE 6
p.000028: TABLE 7
p.000028: TABLE 8
p.000028: TABLE 9
p.000028: RESPONSIBILITIES OF THE INVESTIGATION ETHICS COMMITTEE (CEI) COMPOSITION OF THE INVESTIGATION ETHICS COMMITTEE (CEI)
p.000028: PROCEDURES OF THE INVESTIGATION ETHICS COMMITTEE (CEI)
p.000028: DOCUMENTATION AND RECORD FILE OF THE INVESTIGATION COMMITTEE (CEI)
p.000028: Number of files of participating subjects to be evaluated for each selected study
p.000028: Number of files to select to assess informed consent
p.000028: INVESTIGATOR'S COMPETENCE
...
Social / Women
Searching for indicator women:
(return to top)
p.000016: Chapter II, Table 13
p.000016: Study staff
p.000016: Chapter II, Table 7
p.000016: Compliance with ethical regulations
p.000016: Chapter II, Table 8
p.000016: Adherence to the project while conducting the study
p.000016: Chapter II, Table 9
p.000016: Information management
p.000016: Chapter II, Table 10
p.000016: Inclusion and monitoring of participants
p.000016: in the study
p.000016: Chapter II, Table 12
p.000016: Adverse events presented in participating subjects
p.000016: Chapter II, Table 11
p.000017: 17
p.000017: What happens if there is a breach of any of the requirements?
p.000017: Institutions that carry out clinical studies with medications must meet ALL the requirements
p.000017: stipulated in Chapter II of Resolution 2378 of 2008, in order to guarantee the suitability of the process
p.000017: of research, the protection and safety of the participating subjects and the validity of the results.
p.000017: Taking into account that some of these aspects are more relevant than others, the following is
p.000017: they present the requirements classified into two categories, (high importance and medium importance) defined
p.000017: in accordance with the relationship that each aspect evaluated has with the safety and rights of the subjects
p.000017: study participants.
p.000017: Highly important aspects
p.000017: Failure to comply with critical aspects has a high impact on the quality of the investigation and may jeopardize the
p.000017: safety of the participants.
p.000017: Aspects of medium importance
p.000017: Failure to comply with this section has a medium impact on the quality of the investigation and does not jeopardize the
p.000017: safety of the participants.
p.000017: 1. Number of members (men and women)
p.000017: 2. Minutes of the Committee.
p.000017: 3. Approval of the project by INVIMA or the delegated Health Entity.
p.000017: 4. Files.
p.000017: 5. Regarding the evaluation of researchers.
p.000017: 6. Resumes of the researchers.
p.000017: 7. Records and training certificates for all personnel.
p.000017: 8. Conflict statements signed by the investigator.
p.000017: 9. Manuals of procedures.
p.000017: 10. Handling and procedure of the amendments.
p.000017: 11. Formats of case reports.
p.000017: 12. Written procedures and records.
p.000017: 13. Selection of participants.
p.000017: 14. Controls and monitoring of each and every
p.000017: participants selected for the study.
p.000017: 15. Reports of adverse effects.
p.000017: 16. Handling of biological samples.
p.000017: 17. Instructions for handling the product to be investigated.
p.000017: 18. Informed consent.
p.000017: 19. Registration of the project in a public or private testing network.
p.000017: 1. Manual or operational guide of the Committee.
p.000017: 2. Manual and / or format for preparing reports.
p.000017: 3. Specification in the manual of the number of members required to comply with a quorum.
p.000017: 4. Coincidence in the number of patients recruited and the sample size specified in the project.
p.000017: 4.a. Verification that the patient has a copy of the informed consent.
p.000017: 4.b. Copy of the certificate or certification where INVIMA approved the use of the product for research.
p.000017: NOTE: INVIMA will choose different corrective measures, which will vary according to the
p.000017: number of breaches of these requirements, taking into account this classification.
p.000018: 18
p.000018: How to request an evaluation visit to opt for the Certi fi cation in Good Clinical Practice?
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000022: Participant subject identification code: Unique identifier that the researcher assigns to
p.000022: each subject of the study to protect the identity of the latter and that is used instead of the name of the
p.000022: subject when the investigator reports adverse events and / or some other data related to the study.
p.000022: Coordinating Committee: A committee that may be organized by the sponsor to coordinate the conduct of a study
p.000022: multicenter.
p.000022: Institutional Ethics Committee (CEI): Independent organization made up of medical, scientific members
p.000022: and non-scientists, whose responsibility is to guarantee the protection of the rights, safety and well-being of
p.000022: humans involved in a study through, among other things, constant review, approval and review
p.000022: of the study project and amendments to the documentation and the informed consent of the subjects of the
p.000022: study.
p.000022: Independent Ethics Committee: Independent organization (a review board or institutional, regional committee,
p.000022: national or supranational), made up of medical / scientific professionals and non-medical / non-scientific members,
p.000022: whose responsibility is to ensure the protection of the rights, safety and well-being of human beings
p.000022: involved in a study and provide a public guarantee of that protection of the rights to
p.000022: through, among other aspects, the review and approval / favorable opinion of the study project, the
p.000022: capacity of researchers and the adequacy of the facilities, methods and material to be used when
p.000022: Obtain and document the informed consent of the study subjects.
p.000022: Confidential: Corresponds to information, reports or communications, property of the sponsor or the identity of a
p.000022: subject, which can only be disclosed to others who are authorized or to the health entity
p.000022: correspondent.
p.000022: 2. 3
p.000022: Comparator: A research or marketed product (eg, active control) or placebo
p.000022: (substance that, by itself lacking therapeutic action, produces some curative effect in the
p.000022: ill, if he receives it convinced that he really has such an action) often used in a study
p.000022: clinical.
p.000022: Informed consent: A process by which a subject voluntarily confirms their desire to
p.000022: participate in a particular study, after being informed about all aspects of it
p.000022: relevant and may affect your decision to participate. Informed consent is documented through the
p.000022: informed consent form, which must be signed and dated by the participant, two witnesses and the
p.000022: medical researcher.
p.000022: Quality Control (CC): The techniques and operational activities carried out within the insurance system of
p.000022: quality to verify that the quality requirements of related activities have been met
p.000022: with the study.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000005: National Institute for Food and Drug Surveillance - INVIMA
p.000005: Managing Director
p.000005: Jairo Céspedes Camacho
p.000005: Deputy Director of Health Records
p.000005: Clara Isabel Rodríguez Serrano
p.000005: Deputy Director of Medicines and Biological Products
p.000005: Martha Cecilia Rodríguez Ramírez
p.000005: Deputy Director of Health Supplies and Miscellaneous Products
p.000005: Ana Graciela Criado Aussant
p.000005: Deputy Director of Food and Alcoholic Beverages
p.000005: Laura Pasculli Henao
p.000005: General Secretary
p.000005: Perla Inés Llinás Álvarez
p.000005: Head of the Legal Advisory Office
p.000005: Aura Yineth Correa Child
p.000005: Head of the Planning, Informatics and Statistics Advisory Office
p.000005: Astreed Carolina Sierra Arias
p.000005: Head of Internal Control Office
p.000005: Norma Constanza García Ramírez
p.000005: Content Development Juana Tobos Otálora Paola Vitery Ortíz
p.000005: Adriana Vanegas Sánchez
p.000005: Editorial Coordination Teresa Huertas Molina Silvia Blanco Díaz
p.000005: Design and layout Bernardo Arias Blanco Monica Cabiativa Daza
p.000005: Print
p.000005: www.digitosydisenos.com
p.000005: Bogotá, D.C. 2009 ©
p.000005: Content
p.000005: INVIMA 5 Presentation
p.000005: Introduction 7
p.000005: 1. What is a Good Clinical Practice? 9
p.000005: 2. How were Good Clinical Practices born? 9
p.000005: 3. What is the legal basis for implementation
p.000005: of Good Clinical Practices in Colombia? 10
p.000005: 4. Who is in charge of evaluating the protocols
p.000005: research with drugs in humans? 10
p.000005: 5. Who participates in an investigation
p.000005: with medications in humans? eleven
p.000005: 6. What authority is it to verify
p.000005: compliance with Good Clinical Practices? 12
p.000005: 7. What is the certificate in Good Clinical Practice? 13
p.000005: 8. What is the scope of the certificate
p.000005: in Good Clinical Practice? 13
p.000005: 9. What are the main legal requirements that must be met in Good Clinical Practice and what role
p.000005: Does each member of the system play? 14
p.000005: 10. What are the roles and responsibilities
p.000005: from the main researchers? 17
p.000005: 11. What happens if a breach occurs
p.000005: of any of the requirements? 18
p.000005: 12. How to request an evaluation visit to qualify
p.000005: for the Certification in Good Clinical Practices? 19
p.000005: 13. What other aspects should be taken into account
p.000005: when requesting the evaluation visit? twenty
p.000005: 14. Glossary 22
p.000005: 15. Index of tables of the standard (Resolution 2378 of 2008) 28
p.000005: INVIMA Presentation
p.000005: The National Institute for Food and Drug Surveillance INVIMA is a public establishment of the
p.000005: national order, attached to the Ministry of Social Protection, which as Colombian Health Agency
p.000005: implements policies in the field of health surveillance and quality control.
p.000005: The scope of its management involves products of vital importance to society such as: medicines,
p.000005: biological products, natural and homeopathic products, diagnostic reagents, devices and elements
p.000005: medical surgical and dental, processed foods, meats, packaged beverages, alcoholic beverages,
p.000005: cosmetics, condoms, toiletries, among others.
p.000005: INVIMA's mission is to guarantee public health in Colombia, exercising inspection, surveillance and
p.000005: sanitary control of a scientific technical nature on matters within its competence.
p.000005: In accordance, INVIMA has defined the north of its management on three fundamental axes: guaranteeing the
p.000005: public health in Colombia, contribute to raising the country's health status so that it is recognized at the
p.000005: international, and be a support in competitiveness.
p.000005: INVIMA's Technical and Scientific Character
p.000005: In the execution of health policies, INVIMA interacts with four national systems: System
p.000005: of Public Health, Environmental Health System, System of Sanitary and Phytosanitary Measures and System of Science and
p.000005: Technology.
p.000005: The technical and scientific nature of INVIMA is supported by the Institute's interaction with agencies
p.000005: health organizations, organizations of the academic community, scientific associations and associations of
p.000005: professionals; and inside it is based on the conformation and full functioning of the six Specialized Rooms
p.000005: of the Review Commission (Medicines and Biological Products, Natural Products, Homeopathic Medicines,
p.000005: Food and Alcoholic Beverages, Medical Devices and Various Products, and In Vitro Diagnostic Reagents),
p.000005: in the specialization of the Missionary Subdirections and in the professional capacity of those who make up the teams of
p.000005: job.
p.000005: INVIMA's powers
p.000005: INVIMA develops its management as a Health Authority with the exercise of these powers
p.000005: fundamental:
p.000005: 5
p.000005: • Issuance of Sanitary Registries and Sanitary Notifications
p.000005: • Certification visits
p.000005: • Inspection, Surveillance and Control Actions
p.000005: • Pre and post marketing surveillance, and special programs
p.000005: • National Reference Laboratory
p.000005: • Regulatory harmonization in health matters
p.000005: • Knowledge Management and Applied Research
p.000005: • Training and Technical Assistance
p.000005: • Sanctioning processes
p.000005: INVIMA in the Country
p.000005: INVIMA has placed eight Territorial Working Groups at the service of Colombians, which are being strengthened to
p.000005: consolidate the presence of the Institute in the Country, with the technical, scientific and administrative capacity to assume
p.000005: all your skills.
p.000005: The Territorial Working Groups of INVIMA and its host cities are:
p.000005: 1. Caribbean Coast 1 with headquarters in Barranquilla and coverage in Atlántico, Guajira, Magdalena and Cesar
p.000005: 2. Costa Caribe 2 with headquarters in Montería and coverage in Córdoba, Sucre, Bolívar and San Andrés, Providencia and Santa
p.000005: Katherine
p.000005: 3. Centro Oriente 1 with headquarters in Bucaramanga and coverage in Santander and Norte de Santander
p.000005: 4. Centro Oriente 2 with headquarters in Bogotá and coverage in Boyacá, Cundinamarca and Amazonas
p.000005: 5. Centro Oriente 3 based in Neiva
p.000005: and coverage in Tolima, Huila and Caquetá
p.000005: 6. Occidente 1 with headquarters in Medellín and coverage in Antioquia, Chocó, Caldas, Quindío and Risaralda
p.000005: 7. Occidente 2 with headquarters in Cali and coverage in Valle del Cauca, Cauca, Nariño and Putumayo
p.000005: 8. Orinoquía based in Villavicencio and coverage in
p.000005: Meta, Casanare, Arauca, Guaviare, Guainía, Vichada and Vaupés
...
p.000010: multidisciplinary with critical capacity that watches over the integrity of the participating subjects.
p.000010: • Health Services Provider Institution: This is where the research process takes place.
p.000010: This institution must have the certificate of the “Unique Enabling System”.
p.000010: • The principal investigator: He is the expert doctor in the matters related to the investigation matter, and is
p.000010: who conducts the study.
p.000010: • The clinical laboratory: It is in charge of taking, processing and packaging the samples related to the
p.000010: study.
p.000010: • The sponsor: It is the institution or organization that makes the contributions to finance the study.
p.000010: • The impartial witness: Person (s) who attend the procedure of declaration of informed consent and with
p.000010: Your signature attests that sufficient and clear information has been given about the study's risks and benefits. The witness
p.000010: impartial cannot have any
p.000010: link with the other actors in the investigation.
p.000010: • Participating subjects: People who voluntarily and informedly participate in the process of
p.000010: investigation.
p.000010: eleven
p.000010: SPONSOR
p.000010: Investigator Financer
p.000010: RESEARCH PRODUCT
p.000010: Pharmaceutical form
p.000010: CLINICAL STUDY
p.000010: CENTER WHERE THE STUDY IS CARRIED OUT - IPS
p.000010: Ethics Committee
p.000010: Institutional Independent
p.000010: Principal investigator
p.000010: Research team
p.000010: Clinical laboratory
p.000010: Participating Subjects
p.000010: Impartial witness
p.000010: Which authority is responsible for verifying compliance with Good Clinical Practices?
p.000010: Resolution 2378 of 2008 establishes that it is INVIMA's responsibility to verify that the institutions
p.000010: that develop or intend to carry out research in Colombia with drugs in human beings, comply with
p.000010: Good Clinical Practices and in such a case, it is INVIMA who issues the corresponding certificate.
p.000012: 12
p.000012: What is the certi fi cate in Good Clinical Practice?
p.000012: It is the certificate that INVIMA grants, for a period of five (5) years, to the Institutions
p.000012: Providers of Health Services that advance or wish to initiate research with medications in human beings
p.000012: human, legally authorizing them for this purpose.
p.000012: This document is issued once verification of compliance with the contemplated requirements is verified on inspection visits.
p.000012: in Resolution 2378 of 2008.
p.000012: What is the scope of the certificate in Good Clinical Practice?
p.000012: Taking into account that the Certificate in Good Clinical Practices issued by INVIMA authorizes a whole
p.000012: research process covered under a system, which includes the design, conduct, realization, monitoring,
p.000012: audit, registration, analysis and reporting of clinical studies, will specifically certify the Institutions
p.000012: Providers of Health Services where the studies are carried out.
p.000012: About the other actors (Ethics Committee, clinical laboratory and sponsor), who are fundamental in the process
p.000012: certification, INVIMA evaluators verify compliance with the requirements
p.000012: specifically for each one in Resolution 2378 of 2008.
p.000012: IMPORTANT: Institutions that do not have a clinical laboratory and / or Research Ethics Committee within their
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000022: humans involved in a study through, among other things, constant review, approval and review
p.000022: of the study project and amendments to the documentation and the informed consent of the subjects of the
p.000022: study.
p.000022: Independent Ethics Committee: Independent organization (a review board or institutional, regional committee,
p.000022: national or supranational), made up of medical / scientific professionals and non-medical / non-scientific members,
p.000022: whose responsibility is to ensure the protection of the rights, safety and well-being of human beings
p.000022: involved in a study and provide a public guarantee of that protection of the rights to
p.000022: through, among other aspects, the review and approval / favorable opinion of the study project, the
p.000022: capacity of researchers and the adequacy of the facilities, methods and material to be used when
p.000022: Obtain and document the informed consent of the study subjects.
p.000022: Confidential: Corresponds to information, reports or communications, property of the sponsor or the identity of a
p.000022: subject, which can only be disclosed to others who are authorized or to the health entity
p.000022: correspondent.
p.000022: 2. 3
p.000022: Comparator: A research or marketed product (eg, active control) or placebo
p.000022: (substance that, by itself lacking therapeutic action, produces some curative effect in the
p.000022: ill, if he receives it convinced that he really has such an action) often used in a study
p.000022: clinical.
p.000022: Informed consent: A process by which a subject voluntarily confirms their desire to
p.000022: participate in a particular study, after being informed about all aspects of it
p.000022: relevant and may affect your decision to participate. Informed consent is documented through the
p.000022: informed consent form, which must be signed and dated by the participant, two witnesses and the
p.000022: medical researcher.
p.000022: Quality Control (CC): The techniques and operational activities carried out within the insurance system of
p.000022: quality to verify that the quality requirements of related activities have been met
p.000022: with the study.
p.000022: Essential documents: Documents that individually and collectively allow an evaluation of the driving of a
p.000022: study and the quality of the general data.
p.000022: Source documents: Original documents, data and records (for example, hospital records, clinical sheets, notes
p.000022: laboratory reports, memoranda, subject diaries or evaluation checklists, records of delivery of the
p.000022: pharmacy, recorded data from automated instruments, certified copies or transcripts after
p.000022: verify that they are exact copies, microfiche, photographic negatives, magnetic media or microfilm,
p.000022: x-rays, subjects' records and records kept at the pharmacy in the laboratories and in the departments
p.000022: medical technicians involved in the clinical study).
...
p.000025: Standard Operating Procedures Manual (MPOE): Detailed written instructions to achieve
p.000025: uniformity in the execution of a specific function. Equivalent to the Written Operational Guides (GOC).
p.000025: Monitoring: It is the act of monitoring the process of a clinical study and ensuring that it is conducted, recorded
p.000025: and reported in accordance with the project, Standard Operating Procedures Manual (MPOE), Good
p.000025: Clinical Practice (PCB) and the applicable regulatory requirements.
p.000025: Contract research organization: Person or organization (commercial, academic or otherwise)
p.000025: hired by the sponsor to perform one or more of the sponsor's duties and functions related to the
p.000025: study.
p.000025: Study participant / participating subject: Individual participating in a clinical study, either as a recipient
p.000025: of the products under investigation or as a control subject.
p.000025: Sponsor: Individual, company, institution or organization responsible for initiating, managing,
p.000025: control and / or finance a clinical study. This function may be performed by a corporation or
p.000025: agency external to the institution or by the investigator or hospital institution.
p.000025: Research Sponsor: Individual who initiates and conducts, alone or with others, a clinical trial and
p.000025: under whose immediate direction the product under investigation is
p.000026: 26
p.000026: administered, delivered or used by the subject. The obligations of a sponsor-researcher include both the
p.000026: from a sponsor like a researcher.
p.000026: Standard Operating Procedures (SOPs): Detailed and written instructions to achieve uniformity in the
p.000026: execution of a specific function.
p.000026: Investigational product / medicine: Pharmaceutical form of an active ingredient or placebo that is being
p.000026: testing or using as a reference in a clinical study, including a product with an authorization from
p.000026: marketing when used or conditioned (formulated or packaged) in a manner different from that
p.000026: approved, or when used to obtain more information about a previously approved use.
p.000026: Project: Document that describes the objective or objectives, design, methodology, considerations
p.000026: statistics and organization of a study. Generally also provides background and rationale
p.000026: for the study, but these could be provided in other documents referenced in the project. East
p.000026: term includes its amendments.
p.000026: Audit Report: The sponsor's auditor's written evaluation of the results of the
p.000026: audit.
p.000026: Study subject: The individual participating in a clinical study, either as a recipient of the
p.000026: products under investigation or as a control.
p.000026: Quality system: It is defined as the group of actions and processes that aim to guarantee the quality of the
p.000026: results over time, immediately detect changes in the results due to failures in any of the
p.000026: components of the processes and monitor the different factors that can alter the precision of the results.
p.000026: Impartial Witness: Independent study person, who cannot be influenced in bad faith by staff
p.000026: involved in the investigation, who is present in the process of obtaining informed consent, if the
p.000026: subject or the representative of the subject legally accepted does not know how to read, and who is responsible for reading
p.000026: informed consent and any other written information provided to the subject or by the subject.
p.000027: 27
...
Orphaned Trigger Words
p.000012: It is the certificate that INVIMA grants, for a period of five (5) years, to the Institutions
p.000012: Providers of Health Services that advance or wish to initiate research with medications in human beings
p.000012: human, legally authorizing them for this purpose.
p.000012: This document is issued once verification of compliance with the contemplated requirements is verified on inspection visits.
p.000012: in Resolution 2378 of 2008.
p.000012: What is the scope of the certificate in Good Clinical Practice?
p.000012: Taking into account that the Certificate in Good Clinical Practices issued by INVIMA authorizes a whole
p.000012: research process covered under a system, which includes the design, conduct, realization, monitoring,
p.000012: audit, registration, analysis and reporting of clinical studies, will specifically certify the Institutions
p.000012: Providers of Health Services where the studies are carried out.
p.000012: About the other actors (Ethics Committee, clinical laboratory and sponsor), who are fundamental in the process
p.000012: certification, INVIMA evaluators verify compliance with the requirements
p.000012: specifically for each one in Resolution 2378 of 2008.
p.000012: IMPORTANT: Institutions that do not have a clinical laboratory and / or Research Ethics Committee within their
p.000012: facilities, may have the external support of these components.
p.000013: 13
p.000013: What are the main legal requirements that must be met in Good Clinical Practice and what role does it play?
p.000013: each of the members of the system?
p.000013: In the first instance, INVIMA verifies that the Institution that Provides Health Services where
p.000013: will carry out the study, is certified in the Unique Habilitation System defined by the
p.000013: Ministry of Social Protection and verified by the Secretaries of Health. This Unique System of
p.000013: Habilitation is the set of rules, requirements and procedures by which it is established, registered,
p.000013: verifies and controls compliance with the basic conditions of technological and scientific capacity,
p.000013: patrimonial and financial sufficiency and technical-administrative capacity of health service providers.
p.000013: INVIMA also verifies that the actors involved in the study are clearly defined.
p.000013: clinical.
p.000013: IMPORTANT: The evaluation visits for certification in Good Clinical Practices will be informed by the
p.000013: INVIMA with a maximum of 10 days in advance.
p.000013: The requirements that each of the actors involved in the clinical study must specifically meet are
p.000013: defined in the technical annex of Resolution 2378 of 2008.
p.000013: The Chapters and Reference Tables of these requirements are listed below:
p.000014: 14
p.000014: ETHICS COMMITTEE
p.000014: IN INVESTIGATION AND DELEGATION
p.000014: Compliance with responsibilities
p.000014: Chapter II, Table 1
p.000014: Correct composition of the committee
p.000014: Chapter II, Table 2
p.000014: Compliance with procedures
p.000014: Chapter II, Table 3
p.000014: Existence of required documentation
p.000014: Chapter II, Table 4
p.000014: Manuals, operating guides, procedures, minutes, correspondence, others
p.000014: PRINCIPAL RESEARCHERS
p.000014: Investigator skills
p.000014: Chapter II, Table 5
p.000014: Compliance with the duties and responsibilities of the principal investigator
p.000014: Chapter II, Table 6 - 16
p.000014: Existence of required documentation
p.000014: Chapter II, Table 17
p.000014: Manuals, operating guides, procedures, minutes, correspondence, others
p.000014: fifteen
p.000014: SPONSOR OF THE INVESTIGATIONS
p.000014: Compliance with responsibilities
p.000014: Chapter II, Table 18
p.000014: Functions of the sponsor
p.000014: Chapter II, Table 18
p.000014: Relations with the financing entity
p.000014: Chapter II, Table 20
p.000014: Project files, INVIMA approval document, product delivery and return letters, manuals,
p.000014: budget, monitoring reports, others
p.000014: Existence of required documentation
p.000014: Chapter II, Table 18 - 20
p.000014: SPONSOR OF THE INVESTIGATIONS
p.000014: Application of operating procedures
p.000014: Chapter IV, Table 9
p.000014: Certificate of registration to the special registry of health service providers
p.000014: Chapter IV, Table 9
p.000014: Use of necessary equipment and technology
p.000014: Chapter IV, Table 8
p.000014: Certificate of compliance with enabling conditions
p.000014: Chapter IV, Table 8
p.000014: Compliance with
p.000014: Compliance with laboratory personnel responsibilities
p.000014: procedures for the
p.000014: sample handling
p.000014: Chapter IV, Table 7
p.000014: Laboratory director
...
p.000028: TABLE 9
p.000028: TABLE 10
p.000028: TABLE 11
p.000028: TABLE 12
p.000028: TABLE 13
p.000028: TABLE 14
p.000028: TABLE 15
p.000028: TABLE 16
p.000028: TABLE 17
p.000028: TABLE 18
p.000028: TABLE 19
p.000028: TABLE 20
p.000028: I II
p.000028: TABLE 1
p.000028: TABLE 2
p.000028: TABLE 3
p.000028: TABLE 4
p.000028: TABLE 5
p.000028: TABLE 6
p.000028: TABLE 7
p.000028: TABLE 8
p.000028: TABLE 9
p.000028: RESPONSIBILITIES OF THE INVESTIGATION ETHICS COMMITTEE (CEI) COMPOSITION OF THE INVESTIGATION ETHICS COMMITTEE (CEI)
p.000028: PROCEDURES OF THE INVESTIGATION ETHICS COMMITTEE (CEI)
p.000028: DOCUMENTATION AND RECORD FILE OF THE INVESTIGATION COMMITTEE (CEI)
p.000028: Number of files of participating subjects to be evaluated for each selected study
p.000028: Number of files to select to assess informed consent
p.000028: INVESTIGATOR'S COMPETENCE
p.000028: FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING THE STANDARDIZATION OF PROCEDURES
p.000028: DUTIES OF THE PRINCIPAL INVESTIGATOR WITH RESPECT TO THE STUDY STAFF
p.000028: FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING COMPLIANCE WITH ETHICAL REGULATIONS
p.000028: FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING ADHERENCE TO THE PROJECT DURING THE CONDUCT OF THE STUDY
p.000028: FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING INFORMATION MANAGEMENT
p.000028: RESPONSIBILITIES AND FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING ADVERSE EVENTS PRESENTED IN SUBJECTS
p.000028: PARTICIPANTS
p.000028: FUNCTIONS OF THE PRINCIPAL INVESTIGATOR REGARDING THE INCLUSION AND MONITORING OF PARTICIPANTS IN THE STUDY
p.000028: ROLES / RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR WITH RESPECT TO THE REQUEST FOR INFORMED CONSENT
p.000028: RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR WITH RESPECT TO THE MANAGEMENT OF THE PRODUCT (MEDICINAL PRODUCT) IN INVESTIGATION
p.000028: RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR WITH RESPECT TO THE COLLECTION AND PROCESSING OF SAMPLES AND BIOLOGICAL SPECIMENS
p.000028: RESPONSIBILITIES AND FUNCTIONS OF THE PRINCIPAL INVESTIGATOR WITH RESPECT TO THE DISCLOSURE OF RESULTS OF THE INVESTIGATION
p.000028: DOCUMENTS AND RECORDS THAT THE PRINCIPAL INVESTIGATOR MUST HAVE IN THE FILES
p.000028: RESPONSIBILITIES OF THE STUDIO SPONSOR
p.000028: FUNCTIONS OF THE SPONSOR
p.000028: RELATIONS WITH THE FINANCING ENTITY
p.000028: APPLICATION INSTRUCTION
p.000028: TECHNICAL SHEET FOR THE INSTITUTIONAL EVALUATION OF ENTITIES THAT ADVANCE CLINICAL INVESTIGATION WITH HUMAN BEINGS
p.000028: MANDATORY REQUIREMENTS TO BE FULFILLED BY ALL CLINICAL LABORATORY REQUIREMENTS FOR THE LABORATORY DIRECTOR
p.000028: REQUIREMENTS OF THE PROFESSIONAL IN CHARGE OF THE STUDY IN THE
p.000028: CLINICAL LABORATORY
p.000028: REQUIREMENTS TO BE FULFILLED BY THE PERSONNEL INVOLVED IN THE COLLECTION, PROCESSING, STORAGE AND TRANSPORT OF THE
p.000028: BIOLOGICAL SPECIMENS OF SUBJECTS PARTICIPATING IN THE INVESTIGATION
p.000028: QUALITY SYSTEM
p.000028: INTERNAL AUDIT PROGRAM
p.000028: MANAGEMENT OF SAMPLES OF PARTICIPANTS IN THE INVESTIGATION
p.000028: EQUIPMENT, MATERIALS AND REAGENTS
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| alcoholic | alcoholism |
| authority | Relationship to Authority |
| disability | Mentally Disabled |
| drug | Drug Usage |
| faith | Religion |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| property | Property Ownership |
| sick | Physically Ill |
| single | Marital Status |
| substance | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
developing
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input