NIH establishes new training requirements for clinical trials
A new National Institutes of Health policy effective Jan. 1, 2017 requires investigators involved in the conduct, oversight or management of NIH-funded clinical trials to be trained in Good Clinical Practice (GCP).
GCP principles constitute an international ethical and scientific quality standard, per the International Conference on Harmonisation, for the design, conduct, recording, and reporting of clinical trials.
This training requirement is in addition to and does not replace the basic required human subjects protection training (e.g., PEERRS human subjects modules).
Who’s impacted by this change? All study team members (except administrative staff, unless directed by the principal investigator on a study or by unit-specific business processes) on current active NIH-funded clinical trials are required to hold GCP certification.
- If you have not received GCP training or your training occurred prior to June 1, 2014, you must complete a qualifying GCP course to ensure compliance with the new NIH policy.
- If you have completed GCP training, locate your dated certificate. Study sponsors and IRBs may request proof of GCP certification.
See the HRPP Education Resources website for more information on GCP training requirements and providers.