All investigators and staff are required to complete the online Collaborative Institutional Training Initiative (CITI) human subjects online training program. The CITI site can be accessed at http://www.citiprogram.org. This training is valid for a three-year period, after which time a refresher CITI course or additional training must be completed.
NOTE: To meet the needs of IRB, you must take Biomedical Research Investigators and Key Personnel, Basic Course. Do NOT take “Biomedical Responsible Conduct of Research” as this will not fulfill the Human Research obligation.
Please note that all members of the research team involved in the design, conduct, or reporting of the research are required to complete this training. IRB approval will not be granted for proposed research in which investigators have not completed human research protections training. Investigators who have not completed the required training will be restricted from submitting any new research.
Good Clinical Practice Training
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Good Clinical Practice training will become a requirement for all investigators and staff involved in clinical trials, as defined by the NIH. Similar to the CITI training requirement, GCP training is valid for a three-year period, after which time a refresher course must be completed.
All investigators and staff who are involved in the conduct of Clinical Trials as defined by NIH are required to complete the online Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) course. This training is valid for a three-year period, after which time a refresher course or additional training must be completed. NOTE: Good Clinical Practice Course for Clinical Trials Involving Medical Devices (international focus) is OPTIONAL.
Beginning May 1, 2016, GCP training will be required to support all new clinical trial IRB submissions. Training for investigators and staff submitting clinical trial continuing reviews will be required as of May 1, 2017.
The GCP training may be accessed through http://www.citiprogram.org. Please see the "Good Clinical Practice (GCP) Training at UMMS" Brochure for more information, including instructions on how to access and complete the GCP training requirement.