Good Clinical Practice Training

NIH has issued a new policy that requires training in Good Clinical Practice (GCP) every 3 years.  The new policy is in effect as of January 1, 2017, and covers clinical trials funded in whole or in part by the NIH, regardless of the study phase or type of intervention.  NIH’s new GCP policy applies to both current projects and new awards.  The NIH definition of “clinical trial” is broad and includes all trials regardless of the phase or type of intervention.

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What is the New Requirement:  The new requirement is completion of GCP Training, in addition to other applicable trainings. 

Note: GCP training does not replace Human Subjects Protection training (TC0087).

Who must take GCP training:  All investigators and clinical research staff who work on NIH-funded clinical trials must complete GCP training.

When must GCP training be completed:  Individuals working on currently active, NIH-funded clinical trials should complete GCP training as soon as possible. Failure to complete training will cause delays at protocol renewal. For new clinical trials, training must be completed as a condition for protocol approval.

How to complete GCP training:  On-line GCP training may be completed in Rascal through Course TC3450, which links to the Collaborative Institutional Training Initiative (CITI) training website.  The course must be accessed through the Rascal Training Center here.  Be sure to read and follow the instructions in Rascal to ensure proper credit.  The course takes approximately 2 hours to complete.  Anyone who has completed the course within the past 3 years is not required to retake it before three years.  

Previously completed GCP training through an accredited third-party provider within the past three years may also fulfill the new NIH requirement.  To receive credit for such a course, please send documentation to NIH-GCP@columbia.edu for review.  Completion of TC3450 or another approved GCP course will be reflected on the Rascal IRB Data Sheet.  In addition, individuals are required to maintain training documentation in case of audit or sponsor request.

More information:
The full text of the NIH policy can be viewed here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.
NIH’s definition of “Clinical Trial” is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.

For questions, please email NIH-GCP@columbia.edu.