Colombian regulation for clinical studies
By Marta Faccini
The Colombian Regulation for clinical studies began in 1993 with the issuance of Resolution No. 008430 of 1993 «by which the scientific, technical and administrative standards are established as requirements for the development of research activity in health» and which defines the following points:
- Institutions that carry out research on humans must have a Research Ethics Committee in charge of resolving all matters related to the subject, as well as the ethical aspects of research on human beings.
- As a research risk, the probability that the research subject suffers some damage as an immediate or late consequence of the study (classify the studies according to the type of risk).
- It also defines the informed consent and describes the requirements that must be met in the process. It establishes the conditions for carrying out studies in communities, in minors, subordinate or disabled groups, women of childbearing age, pregnant women, during labor, the puerperium, lactation and newborns, the use of embryos, deaths and fetuses and in cases of artificial fertilization, research on organs, tissues and their derivatives, or of new prophylactic, diagnostic, therapeutic and rehabilitation resources.
- Lastly, it defines the pharmacological investigations and the biosafety of the investigations and the cases in which these investigations can be carried out in the country. Resolution No. 3823 of 1997 established that drug research projects must be evaluated by the National Institute of Food and Drug Surveillance – INVIMA and subsequently Resolution No. 2378 of 2008 is issued «by which Good Clinical Practices are adopted for the institutions that conduct research with drugs in humans ”and in which INVIMA is delegated the responsibility of certifying and ensuring that the clinical studies carried out in the country are conducted in research centers in accordance with national and international standards .
It describes the requirements and evaluation processes that institutions that carry out clinical research in humans must comply with, taking into account the ethics committee, researcher, sponsor and clinical laboratory in order for each institution to obtain the certification that allows it to conduct clinical studies.
Resolution No. 2378 of 2008 establishes that the institutions where investigations are carried out with human beings, through the application and use of drugs, must have the certification of the conditions of the Unique System of Habilitation.
This implies that the research centers must also comply with the provisions of Resolution No. 2300 of 2014 «by which the procedures and conditions for registration of Health Service Providers and health services qualification are defined,» Decree Nº 2200 of 2005 “by which the activities and / or processes of the pharmaceutical service are regulated”, Resolution Nº 1403 of 2007 “by which the Management Model of the Pharmaceutical Service is determined, the Manual of Essential Conditions and procedures and other provisions «, Resolution No. 0444 OF 2008″ by which the Instrument for Verification of Compliance with Good Preparation Practices of Magisterial Preparations is adopted and other provisions are issued «and Decree No. 351 OF 2014» by which regulates the comprehensive management of waste generated in health care «and Resolution No. 1995 of 1999 that» establishes the standards for the management of clinical history ica ”.
Resolution No. 2011020764 of 2011 establishes the processes and periodicity of reports of adverse events in the clinical research phase with drugs in humans and applies to the report of Adverse Events associated with the safety of drugs in research with humans.
In addition to the aforementioned standards, Invima has generated Guidelines for the development of clinical studies that must be reviewed and implemented by the centers that carry out clinical studies:
- Guide for Research Ethics Committees (version of April 1, 2015) which describes the guidelines that the user must take into account for the formation, procedures, monitoring, surveillance and interaction of the Independent Ethics Committees with INVIMA .
- Guide for the Evaluation and Follow-up of Research protocols (version of May 5, 2016) whose objective is to publicize the guidelines for the evaluation, follow-up and completion of research protocols with drugs that are carried out in Colombia
- Guide of Medicines and Supplies for Clinical Research (version of April 1, 2015) which seeks to guarantee the proper handling and use of the investigational medicine in all its stages, from its manufacture to its destruction, as well as to guide the appropriate processes for the import, export of investigational drugs, other clinical research supplies and biological samples
- Guide for the selection of the Principal Investigator (version of April 1, 2015) describes the guidelines for the selection of the Principal Investigator and the criteria to establish their roles and responsibilities.
The main purpose of these regulations is to guarantee the protection of the rights, safety and well-being of the subjects participating in clinical research, and that these maintain the ethical and scientific guidelines that allow obtaining final reports of total quality and reliability. However, it generates for research centers the need to implement Quality and Risk Management programs that guarantee adherence to the regulatory framework established by the Institutions, researchers, Ethics Committees, and the entire team that participates in the implementation and development of clinical studies.