University of Rochester

Human Subject Protection & Good Clinical Practice Training

Instructions for Registering and Completing HSP & GCP Training

Human Subject Protection (HSP) Training

As described in Office for Human Subject Protection (OHSP) Policy 201 Education Program, all research personnel engaged in human subject research are required to successfully complete and maintain Human Subject Protection training prior to conducting human subject research. This training is completed through an online program called the Collaborative Institutional Training Initiative (CITI). Instructions for registering and completing the required training modules are provided in the document linked above.

If you are new faculty/staff/student and have already completed Human Subject Protection training in CITI through another institution, you are still required to complete the University's version of this training in CITI. However, credit for HSP modules you've previously completed in CITI (within the 3-year maintenance window) should transfer into your University of Rochester coursework. In order to facilitate the transfer of credits, you must add the University of Rochester as an additional affiliation in your existing CITI account. Instructions for doing so are provided in Section B of the instructions linked above.

If you have any questions about registering for or completing this training, please contact Kelly Unsworth or Janice Taylor.

Good Clinical Practice (GCP) Training

Good Clinical Practice training, in addition to Human Subject Protection training, may be required for research personnel:

• Most industry-sponsors of research involving investigational products (drugs, devices, biologics) require research personnel to complete and maintain Good Clinical Practice training.
• The National Institutes of Health (NIH) requires "all NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical be trained in Good Clinical Practice..." The NIH Policy on GCP Training defines a clinical trial 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". The policy further defines clinical trial staff as "individuals, identified by the investigator, who are responsible for study coordination, data collection and data management".
• Some University of Rochester managers/supervisors and/or departments require specific research personnel to complete and maintain Good Clinical Practice training.

New and inexperienced research personnel, including investigators and study staff, are also encouraged to complete GCP training regardless of whether it is required. For an explanation of what 'Good Clinical Practice' is and how it relates to research compliance (including social-behavioral research), see the Office for Human Subject Protection Q3 2020 Newsletter.

Good Clinical Practice training is available to all University faculty/staff/students via CITI (including a Food & Drug Administration [i.e., drug/device/biologic] and social-behavioral GCP training options). Instructions for registering and completing this training through CITI are linked above. Good Clinical Practice training completed though other training platforms may also be acceptable, if the training meets the minimum criteria for mutual recognition (see TransCelerate Biopharma, Inc.'s GCP Mutual Recognition webpage and their list of recognized GCP courses for additional information).

If you are unsure of whether you are required to complete this training, or whether your existing training is acceptable, check with your funding agency/sponsor and/or supervisor.

Required Training

• HSP & GCP Training

Training Resources

• Education & Training Framework
• Quick Reference Guides
• Seminars
• OHSP Help
• Professional Certification
• Listserv Signup

Click® IRB Training

• Click® IRB Training