GCP training required for clinical trial personnel

All personnel conducting human-subject research (HSR) overseen by the UNMC Institutional Review Board (IRB) must complete initial and continuing education regarding protection of subjects' rights and welfare.

This training is accomplished in part through the Collaborative Institutional Training Initiative (CITI), a web-based training program. In the past, the CITI Human Subject Research (HSR) course was required and the Good Clinical Practice (GCP) course was optional.

Guided by international ethical and scientific quality standards, numerous countries have adopted the ICH-GCP guidelines. Many clinical trial sponsors are now requiring compliance with the ICH-GCP standard, which generally includes additional training for research personnel.

In the ongoing effort to provide clinical investigators and research personnel with high quality training, Vice Chancellor for Research Jennifer Larsen, M.D., and the IRB have recently mandated the completion of the GCP modules in addition to the currently required HSR modules for the CITI course. At the time of initial CITI training or re-certification, all individuals involved in the conduct of clinical trials involving drugs and/or devices will be required to take the "Group 1 Biomedical Course for Clinical Trials Involving Drugs and/or Devices" course. The GCP modules have been incorporated into that course.

This GCP course meets the minimum training requirements for many sponsors. By providing the CITI Completion Report to those sponsors, often no additional GCP training will required. Click here to see the list of sponsors that accept this course.

Investigators and research personnel not involved in the conduct of clinical trials involving drugs and/or devices are not required to complete the GCP modules. At the time of initial CITI training or re-certification, those individuals will complete "Group 2 Biomedical studies not classified as clinical trials involving drugs or devices."

If you have any questions regarding CITI training, contact Jenny Kucera, jikucera@unmc.edu or (402) 559-6119. Additional information and CITI instructions can be found on the IRB website.