Human Research Training
Initial Training Requirements
Initial training requirement can be met by completing one of the following options:
- Yale web-based training program
- CITI basic training, available through the Yale training and certification website
- Complete the NIH Protecting Human Research Participants training program (the certificate of completion of this training must be provided to the IRB Office for manual entry into the system);
- Completion of training from some other training provider, i.e., another University’s training program, DHHS or the FDA. Documentation of completion along with the detailed description of the training must be provided to the IRB office for verification and manual entry into the system.
The continuing education requirement can be met by attending any Human Research Protection Program educational session, or by completing any one of the Yale human research modules, or any one of the CITI continuing education modules available through the training and certification website.
Investigators engaged in human subject research conducted at HIPAA covered entities that involves collection or interaction with PHI, must also complete HIPAA training. HIPAA training modules.
Good Clinical Practice Training
Individuals engaged in the conduct of a clinical trial (per the NIH definition) must complete a Good Clinical Practice (GCP) training. The training must be refreshed every three years. Any of the following will satisfy the initial and/or continuing education GCP training requirement:
- Attendance at the instructor-led GCP training offered by Yale Center for Clinical Investigation (YCCI) or Yale HRPP. The sessions are offered several times a year. Registration is available through Training Management System. Sign up for the HRPP newsletter to be notified about the upcoming sessions.
- Completion of the industry-sponsored GCP training conducted by the TransCelerate identified provider. The certificates should be emailed to email@example.com for data entry.
- Completion of the online training. The links to the online training sessions are available in the Training Management System.
- Completion of any single GCP course through CITI. Once you log in, add a new course from the Main Menu. You will be offered different courses in the Yale portfolio. Be advised that Human Subject Research and Responsible Conduct of Research courses do not satisfy the GCP training requirement. See below for a screenshot of the available GCP courses. CITI notifies the HRPP Office when a course has been successfully completed (all modules within a course must be completed). The TMS and IRES IRB records are updated within 1 to 2 business days.
- Please, see the guide for step-by-step instructions on how to complete CITI GCP training.