- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Good Clinical Practice (GCP) Training
Study team members wishing to complete supplemental GCP training, in addition to human subjects training, may do so via the Collaborative Institutional Training Initiative (CITI). While this training is not required by the University, it may be required by sponsors and/or funding agencies (see information below regarding National Institutes of Health GCP training requirements). Note that because this training is optional, study team members must maintain all documentation related to completion of this GCP course themselves; the Office for Human Subject Protection (OHSP) does not monitor completion of this course.
To access this course, go to the CITI webpage at www.citiprogram.org and enter your username and password to log in:
- From the Main Menu, click the arrow immediately to the left of “University of Rochester Courses” to display your coursework and then select “Add a Course”.
- Select “Good Clinical Practice” and click “Next”. One the following page, select either the basic or refresher Good Clinical Practice courses and click “Next”. To begin the course, click the name of the course listed on the Main Menu, complete the “Integrity Assurance Statement” and then select the name of the first module under the Required Modules listing.
- Once you have completed the course, print (or save) a copy of the Course Completion report.
National Institutes of Health (NIH) GCP Training Requirements
Effective January 1, 2017, NIH requires all funded “investigators and staff who are involved in the conduct, oversight or management of clinical trials” be trained in Good Clinical Practice (see NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials). The policy further requires Investigators to take a refresher GCP training course every three years.
Based on the language in the policy (“GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization”), OHSP anticipates the requirement can be fulfilled via one of the mutually recognized GCP training platforms identified through TransCelerate BioPharma, Inc. The CITI GCP training is included as a recognized platform.
Additional FAQs pertaining to the NIH policy is available here.
If you have any questions about registering for CITI or completing this training, please contact Kelly Unsworth at (585) 275-5244 or by email.
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