Human Subjects Research Training
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.
Have you completed the CITI at another institution? If so, take the following steps to get credit for the modules completed within the past three years:
A. GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Meets the Minimum Criteria for ICH GCP training as recognized byTransCelerate BioPharma to allow mutual recognition of GCP training among trial sponsors
B. NIH - Social & Behavioral Research Best Practices for Clinical 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.
All investigators and staff who are involved in the conduct of Clinical Trials as defined by NIH are required to complete online CITI training in (GCP). This training is valid for a three-year
Effective May 1, 2016, online CITI training in GCP is required to support all new clinical trial IRB submissions. Effective May 1, 2017, GCP training is required for investigators and staff submitting clinical trial continuing reviews. Exceptions are granted for continuing reviews that are solely in long-term follow-up or data analysis.
CITI will show the four options listed below. Choose either the first or second course as best fits your research needs. Course 3 is optional and will not satisfy the UMMS requirement.
▢ GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - This course meets the UMMS requirement and the minimum criteria for ICH GCP Investigator Site Personnel Training
▢ NIH - Social & Behavioral Research Best Practices for Clinical Research - This course meets the UMMS requirement.
▢ OPTIONAL: Good Clinical Practice Course for Clinical Trials Involving Medical Devices (international focus).
▢ Not at this time.
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