Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the National Food and Drug Surveillance Institute (INVIMA) in Colombia. Here is an overview of this registry:

Registry name: National Food and Drug Surveillance Institute (INVIMA)

Country: Colombia

Year established: 2012

Points of interest:

  • Clinical trials in Colombia must be reported to INVIMA
  • In 2012, INVIMA was restructured to take on additional responsibilities for the country’s public health, including increased transparency and surveillance measures
  • Protocol registration for all interventional clinical trials occurring in Colombia are mandatory, in the Spanish language
  • The principal clinical trial researcher must submit written summaries covering the status of the study to a research ethics committee at least once a year
  • The researcher must notify the INVIMA of any significant change that affects the conduct of the trial
  • Regardless of the study’s outcomes, the principal researcher is responsible for disseminating the study data is disseminated among the scientific community
  • Under the Colombian Data Privacy Law (1581/2012), clinical trial data is considered a “special data category” because it encompasses personal health data. As such, the researchers must obtain written consent from subjects.

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