Updated May 2, 2017
In September 2016, NIH announced that all NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). This new training requirement is effective January 1, 2017, and applies to all new and existing NIH clinical trials. The policy requires basic GCP training and refresher GCP training every three years. The NIH policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html. For existing NIH-funded studies meeting the definition of a clinical trial, completion of the GCP training is required by the time of the next continuing review.
In order to satisfy this new federal training requirement, beginning January 1, 2017, all research investigators and staff at University Park and Commonwealth locations who are involved in an NIH-funded study meeting the definition of a clinical trial (as defined by NIH below) will be required to complete GCP training. Investigators and staff at Hershey Medical Center and the College of Medicine should contact the Human Subjects Protections Office (717-531-5687 or email@example.com) for more information about the College of Medicine’s implementation of this new training requirement.
A clinical trial is defined by NIH 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.” See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html. Or learn more on our website: https://www.research.psu.edu/qm/clinicaltrials.
Researchers and staff at University Park and Commonwealth locations will be required to take one of the following GCP trainings to satisfy this new training requirement:
Social or Behavioral Research:
- "GCP for Social and Behavioral Researchers" Penn State Learning Resource Network CITI: lrn.psu.edu
Completion reports should be sent to IRB-ORP@psu.edu (not automatically recorded in CATS IRB)
- CITI: citi.psu.edu
- NIAID: http://gcplearningcenter.niaid.nih.gov/
- Clinical Trial Network: https://gcp.nihtraining.com/
GCP Training taken through CITI will be automatically recorded in CATS IRB. Completion reports from any other GCP training should be sent to IRB-ORP@psu.edu.
For questions related to this new NIH-imposed training requirement or about which GCP training is most appropriate for you, please contact your IRB Analyst or the IRB Program at IRB-ORP@psu.edu.