New Institutional Training Requirement for NIH funded Clinical Trials, Effective 12/05/2019

Published: December 4th, 2019

Category: Announcements, News

NIH Policy NOT-OD-16-148 (https://grants.nih.gov/grants/guide/notice-files/not-od-16-148.html) requires all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials (biomedical or behavioral) to be trained in Good Clinical Practice (GCP).

The NIH definition of a clinical trial is “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”.

Although GCP is not an IRB required training, the Institution has determined that the UF IRBs will confirm UF researchers’ compliance with this requirement.

Effective December 5th 2019, all PIs and SS engaged in NIH-funded clinical trials (biomedical or behavioral) must provide documentation that GCP training has been completed to the IRB. Training verification will be part of the myIRB submission process when researchers/study staff agree to participate on a study. If the training is not on file, one will not be able to agree to participate on the NIH-funded clinical trial.

What studies are affected? This requirement will affect all studies, new and existing that meet the NIH’s above definition of a clinical trial.

Who must take the training? The PI and all study staff listed in myIRB must provide documentation of GCP training completion.

Which GCP training must be completed? Any GCP training that provides a current completion certificate will suffice.

How do researchers/staff provide documentation of GCP training completion? Email a copy of your GCP completion certificate to ufirb-l@lists.ufl.edu. Once received, IRB staff will enter your training records into myTraining after which it will take 48 hours for the training to process in the system. Please budget this time in your submission schedule.

When does the training have to be completed? For new studies, training certifications for all research staff must be sent to the IRB and processed in the system (note the 48-hour timeframe) before the study can be submitted to the IRB for review. For currently approved studies, training certifications for all research staff must be sent to the IRB and processed in the system (note the 48 hour timeframe) before the PI can submit (a) any revisions or (b) the continuing review to the IRB for review.

How often does training have to be completed? GCP training must only be completed every 3 years.

For additional information please see our Investigator Guideline at: http://irb.ufl.edu/irb01/researcher-information/investigator-guidelines.html

For questions, please call or e-mail the relevant IRB offices. <352-273-9600 or ufirb-l@lists.ufl.edu>