Good Clinical Practices (US FDA Focus)
Investigators and key personnel who participate in the design, conduct, and/or reporting of research involving human subjects at Ohio State must complete training in human subjects protection. The CITI Basic and Refresher Human Research Courses are used to meet this requirement. Sponsors or funding agencies may also require researchers who conduct clinical research to demonstrate knowledge of good clinical practices. The CITI Good Clinical Practice (US FDA Focus) Basic and Refresher Courses can be used to meet this requirement. The CITI Basic Human Research Course is a prerequisite for taking the GCP Course. Formal GCP training for clinical investigators is not currently required by the University.
Note: The GCP Basic and Refresher courses align with the new NIH policy issued on September 16, 2016 Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148 stating that NIH-funded investigators and staff should be trained in GCP. This policy takes effect January 1, 2017.
The Good Clinical Practice (US FDA Focus) Course may not be used to satisfy Ohio State requirements for training in human subjects protection. Print and retain a copy of the completion report for your records.
Continuing Medical Education (CME or CEU)
Continuing education credits for physicians, physician’s assistants, nurses, psychologists and other health care providers may be available through the University of Miami Miller School of Medicine Division of Continuing Medical Education. See Continuing Education Credits for CITI Courses for more information.
Questions or Assistance
Ellen Patricia, MS, CIP
Assistant Director, Quality Improvement and Operations
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210