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Beginning January 1, 2017
NIH Policy on Good Clinical Practice (GCP) Training Now Required

December 16, 2016

The NIH recently issued a Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials

While IU has an existing training requirement with regard to Good Clinical Practices (http://researchcompliance.iu.edu/hso/hs_inv_req.html), the NIH requirement does differ slightly in regards to scope, affected personnel, and training mechanism.

IU has elected to enforce the NIH training requirement as a condition of IRB approval. Consequently, the IU Human Subjects Office (HSO) will be verifying GCP training completion for applicable personnel on NIH-funded clinical trials during the IRB review process.

Important considerations:

  • The GCP training requirement for NIH-funded clinical trials applies to more study personnel than the existing IU GCP training requirement. In particular, Clinical Trial Site Staff are required to have evidence of GCP training for NIH-funded clinical trials.
  • GCP training for affected personnel on NIH-funded clinical trials may be accomplished by various methods (refer to table below).
  • If the training occurred via a mechanism other than the CITI GCP Course, please provide the documentation of training for each affected individual with the IRB study submission.
  • The HSO will verify training for new and renewing (i.e., continuing reviews of) NIH-funded clinical trials.
  • The GCP training must have been completed within the past 3 years. In other words, GCP training must be renewed every 3 years.

REQUIREMENTS FOR GOOD CLINICAL PRACTICE (GCP) TRAINING
IU Requirements NIH Requirements
Scope Interventional clinical trials, irrespective of funding NIH-funded clinical trials
Personnel - Principal Investigators
- Co-Principal Investigators
- Investigators
- Clinical Trial Site Staff responsible for
the conduct, management, and/or oversight of trials (‘Key Personnel’ as defined by the IU IRB)
Training via CITI GCP Course - Class/course
- Academic training program
- Certification from recognized clinical research professional organization
Refresher requirement 3 years 3 years

Please contact the HSO at irb@iu.edu or 317.274.8289 with questions.