NEW Policy on Good Clinical PracticeTraining for NIH Awardees Involved in NIH-Funded Clinical Trials -Effective January 1, 2017

On September 16, 2016, the National Institutes of Health (NIH) issued a new policy stating that NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP).1 This policy takes effect January 1, 2017.

The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”2

NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Acceptable GCP courses include the Collaborative Institutional Training Initiative (CITI) GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course as well as the CITI GCP FDA Refresher Course.  Other acceptable GCP courses include the NIAID GCP Learning Center website (http://gcplearningcenter.niaid.nih.gov) and National Drug Abuse Treatment Clinical Trials Network (https://gcp.nihtraining.com/). GCP training may also be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. GCP Training is required every three years.

The Office of Research Human Research Protections (HRP) unit will monitor completion of the CITI GCP training courses similar to the current monitoring of the HRP and HIPAA training.  For individuals who complete non-CITI GCP training please retain and submit certification of GCP training to the HRP unit (via email at ).  Full implementation of this policy is expected by March 1, 2017.  Noncompliance could result in delays in IRB approval.

For more information about the policy click on this link: Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148.

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1 http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073122.pdf

2 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

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