Clinical protocols to be assessed in 2 months
On April 12, 2016, the Colombian National Institute for Drug and Food Surveillance (INVIMA) reported that the time to assess clinical trial research protocols will be reduced from 4.5 to 2 months. The reduction will be achieved through the improvement of the processes, without compromising the quality of the evaluation.
Every clinical research project begins with the development of a clinical research protocol, which is a document that describes how the clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected. The protocol includes information regarding the background, goals, design, methodology, statistical considerations and organization of the clinical trial.
The two main changes that will allow to improve the efficiency of the assessment process are: a) the performance of the technical assessment of the research protocol and the quality of the drug simultaneously, and b) the transfer of the technical assessment of the research protocol from the Specialized Board for Drugs and Biological Products to the Clinical Research Group of the Directorate for Drugs and Biological products.