The letter, authored by Dr. Carrie Wolinetz of the National Institutes of Health (NIH), addresses concerns raised by Anthony P. DeCrappeo, President of the Council on Governmental Relations (COGR), regarding the NIH’s policy on Good Clinical Practice (GCP) training for NIH awardees involved in NIH-funded clinical trials. Dr. Wolinetz acknowledges the dialogue and expresses appreciation for the thoughtful input from COGR, specifically in relation to the policy’s scope, implementation timeline, and impact on institutional processes. She clarifies that while the GCP training requirement is set to become effective at the start of the new year, institutions are not expected to have every staff member trained immediately upon the policy’s effective date; rather, a reasonable, ongoing approach to compliance is acceptable as long as steps are being taken to meet the requirement in a timely manner.
Furthermore, Dr. Wolinetz explains that the policy targets individuals directly responsible for the conduct, oversight, and management of clinical trials—including those involved in coordination, data collection, and data management—without imposing an unduly broad mandate. She notes that the GCP training aligns conceptually with, but is not identical to, other NIH personnel and training policies, offering institutions the flexibility to apply the requirements more broadly if desired. Dr. Wolinetz also suggests that institutions can leverage existing tracking systems to reduce administrative burden, and she observes that many clinical investigators may already meet these standards due to institutional policies. She concludes by reiterating NIH’s commitment to supporting institutions throughout the implementation process and announces plans to release additional clarifying materials in the form of FAQs.
