NIH institutes new policy on Good Clinical Practice training for awardees involved in clinical trials

A new policy of the National Institutes of Health (NIH) affects investigators and staff who are involved in the conduct, oversight, or management of clinical trials that are: (1) funded by NIH, and (2) that are listed on clinicaltrials.gov.

The policy establishes the expectation that those involved in clinical trials, e.g., those having direct contact with subjects or their data, should be trained in Good Clinical Practice (GCP). It went into effect in January 2017, and applies to all active grants and contracts, including those awarded before the effective date. The policy applies specifically to clinical trials, although NIH suggests that GCP training may also be helpful for those investigators and staff involved in clinical research studies.

GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Recipients of GCP training are expected to retain documentation of their training, and to provide documentation to the IRB office for inclusion in the Protocol Management System.

Virginia Tech uses an online training course created and maintained by the Collaborative Institutional Training Initiative (CITI), a nationally recognized resource for research-related training, to meet the GCP training requirements. For details about GCP training at Virginia Tech, contact Debbie Geiger at debg14@vt.edu or (540) 231-3732.

For more information about the NIH policy on GCP training, see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.

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