COGR Requests More Time To Comply with NIH Good Clinical Practice Policy

October 10, 2016 | By Jerry Ashworth | Post a Comment

lab-work_lgThe National Institutes of Health (NIH) recently issued its Policy on Good Clinical Practice (GCP) Training for NIH Awardees Involved in NIH-funded Clinical Trials, but many research universities fear that the implementation date of the policy — Jan. 1, 2017 — is unrealistic. Anthony P. DeCrappeo, president of the Council on Governmental Relations (COGR), which represents numerous research universities and medical centers, last week sent a letter to NIH seeking an extension of the policy implementation date to May 1, 2017.

The letter states that some institutions have longstanding programs based on GCP principles for clinical investigators working on Food and Drug Administration (FDA)-regulated industry-sponsored clinical trials. However, NIH’s GCP policy now expands the number of investigators required to complete such training and also requires institutions to develop a compliance infrastructure that may not have existed before. COGR had three concerns in particular with the NIH policy.

First, COGR said the effective date is too early. “Institutions take training obligations seriously and need sufficient time to meet NIH’s expectations,” according to the letter. “Despite regular interactions with NIH through various channels, our university members were not aware that this policy was set to be issued. To implement this policy, institutions may need to: (1) identify and adapt an appropriate training program as necessary; (2) integrate it into their existing training systems; and (3) identify, and establish contacts for, staff subject to this new training requirement.” It further noted that NIH’s definition of “clinical trial staff” may include individuals who were not previously identified as members of the study team, such as a computer programmer or database manager who has no contact with research subjects, but is responsible for data management. Because of these concerns, COGR requested that the implementation date be extended to May 1, 2017.

COGR also questioned the definition of “investigator.” The policy defines an investigator as “the individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.” COGR said this definition differs from the FDA’s definition of “investigator.” “This lack of consistency is bound to create confusion among researchers and administrators, as the same word has different meanings depending on which NIH policy is being applied,” COGR said. It suggested that in the GCP policy, NIH replace the term “investigator” with the term, “clinical investigator,” defined as “the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of a clinical trial funded by the PHS, including but not limited to responsibility for study coordination, data collection and data management, recruitment and informed consent, and compliance with regulatory and reporting requirements.”

Lastly, COGR sought clarification on when and to whom this policy applies. “Does the policy apply only to proposals submitted and awarded on or after the effective date?” GOGR asked in the letter. “COGR member institutions feel strongly that it should apply only on a go-forward basis. Applying this policy to all active awards will require significant administrative work to identify the awards and the applicable staff, a task made even more difficult by the Jan. 1 effective date.”

We’ll follow the course of this policy to see if NIH opts to change the implementation date, or if it makes any of the other suggested changes.

Let us know your reaction to this letter on the Good Clinical Practice policy. Does COGR have a point?

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