FDA Data Compliance

Will the FDA accept data from a clinical research site in Colombia?

For international inspections of pharmaceutical trials, the FDA requires conducting the trials according to GCP and under the Ethics Committee approval. For medical devices, the FDA requires the conduct of the trial according to the Declaration of Helsinki (a requirement by Colombian law in Resolution 2378) and to the laws and regulations of the country where the trial is taking place.

If a Colombian research site receives a Good Clinical Practice Certificate from INVIMA, then it is also compliant with FDA requirements for international inspections for studies involving investigational drugs and biologics as well as for studies involving investigational medical devices.

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The following provides information regarding the Good Clinical Practice Certificate (GCP) that a clinical research site in Colombia receives from Colombia’s regulatory agency, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos; translated as National Drug and Food Surveillance Institute) and how it relates to conducting an FDA-compliant clinical trial in Colombia.

The International Conference on Harmonization issued the document titled Guidelines for Good Clinical Practice (please see Attachment 1 on this folder), which defines a set of guidelines by which clinical studies can be designed, implemented, completed, audited, analyzed and reported to ensure reliability. Latin American countries are not a part of the International Conference on Harmonization; however, conducting clinical studies in Latin American  countries —and the rest of the world— must follow strict ethical and scientific principles as it is described in the Declaration of Helsinki, the Nuremberg Code, the Declaration of Geneva and all the declarations related to the ethical conduction of clinical trials.

In this context, it became necessary to define harmonized GCP criteria in Latin America. In 2005, the Pan-American Health Organization —a regional office of the World Health Organization— held a meeting in the Dominican Republic in order to develop the Document of the Americas (please see Attachment 2 on this folder) to propose the guidelines for Good Clinical Practice throughout the region and to serve, as the foundation for regulatory agencies, investigators, ethics committees, universities and companies engaged in clinical research. The Pan-American Health Organization submitted the final version of the document to all Latin American countries in order to standardize the conduction of clinical trials throughout the continent.

The Ministry of Health and Social Protection of the Republic of Colombia received the Document of the Americas  and decided to adopt its proposed Good Clinical Practice guidelines in Colombia by issuing national law through Resolution 2378 (please see Attachment 3 of this folder) by which Good Clinical Practices are adopted by institutions conducting clinical research in human beings. This resolution is a list of requirements that clinical research sites in Colombia are obligated to follow in order to receive a Good Clinical Practice Certificate. These requirements apply to the principal investigator, the ethics committee, the clinical laboratory service, the pharmaceutical service and set standard operating procedures for all the required services and activities, as well as the training that all the personnel involved in clinical research must receive (i.e. research methods, ethics and Good Clinical Practice).

The Ministry of Health and Social Protection of the Republic of Colombia mandated INVIMA to issue the Good Clinical Practice Certificate to clinical research sites in Colombia that comply with its strict guidelines. Resolution 2378 has a comprehensive checklist that every site must complete. INVIMA then visits every site that applies for the certificate, verifies its compliance with the resolution´s checklist and grants the certificate (please see an example certificate on Attachment 4 of this folder).

With respect to whether the INVIMA Good Clinical Practices Certificate is compliant with FDA requirements, please refer to the following information which is taken from the Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators (please see Attachment 5 of this folder).


Studies Involving Investigational Drugs and Biologics

When FDA considers whether to accept non-U.S., non-IND clinical studies in support of an IND, NDA, or BLA, an FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 312.120. Specifically, the inspection will evaluate whether the following criteria are met:

  • The study is well-designed and well-conducted.
  • The study is conducted in accordance with Good Clinical Practice (GCP), which is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.
  • The study has been reviewed and approved (or provision of a favorable opinion) by an independent ethics committee (IEC) prior to study initiation, continuing review of an ongoing study by an IEC, and the freely given and documented informed consent of the subject (or the subject’s legally authorized representative if the subject is unable to provide consent) prior to any study-specific procedures.

Studies Involving Investigational Devices

FDA’s inspection of clinical investigators conducting foreign trials includes device trials in support of a premarket approval application (PMA) or a premarket notification (510(k)) submission.

For device studies conducted outside the U.S., FDA will accept research in support of a PMA, but which has not been conducted under an IDE, if certain conditions are met. An FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 814.15. Specifically, the inspection will evaluate whether the following criteria are met:

  • the data are valid; and
  • the studies are conducted in conformance with the “Declaration of Helsinki,” or the laws and regulations of the country in which the research is conducted, whichever affords greater protection to the human subjects.

FDA validates the authenticity and accuracy of data and confirms compliance during an inspection, which is performed under the circumstances listed above in section III. The FDA investigator may request documentation as to whether the study was conducted under the laws and regulations of the non-U.S. country and/or the Declaration of Helsinki, whichever accords greater protection to human subjects.

On April 22, 2015, the FDA issued a new draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States. The guidance recognizes the likelihood of increasing use of foreign data in the future, stating: “The number of IDE applications and submissions for marketing authorization supported by OUS clinical trials has increased in recent years and will likely continue to increase in the future.” The guidance reiterates the general principles regarding acceptance of foreign data described above, but it also provides examples of successful and unsuccessful uses of foreign data in prior submissions. The FDA also has issued a proposed rule (Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices, 78 Fed. Reg. 12,664 (Feb. 25, 2013) (to be codified at 21 C.F.R. pt. 807), not yet finalized, that would require foreign clinical data in all premarket submissions to comply with Good Clinical Practices (GCPs).

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