CITI Training Requirements
Initial Submissions and Annual Reviews submitted to MMC-IRB require GCP training to be completed before the study can receive approval.
Acceptable GCP Training will be certified either by way of the CITI program, or by an approved Transcelerate alternative course. Transcelerate is a collaborative platform used largely by industry where a GCP course is evaluated on its core components. When a course is accepted for registration by Transcelerate it is interchangeable with CITI GCP. Transcelerate-approved programs can be verified by following this link.
Good Clinical Practice (GCP)
- All investigators or personnel conducting, supervising, or participating in research projects within, or by way of, any Maine Medical Center, Maine Medical Partners, or MaineHealth facility are required to successfully complete one of the following training programs.
- CITI Program GCP course:
- “US Only Drug or Device” – Recommended
- “International Drug Research” – May be required by certain industry-sponsors
- Transcelerate-approved GCP training: Select from the Lists of the ICH GCP Training Meeting the Minimum Criteria
- Please check with your sponsor or select the course, listed above, that aligns with your research.
- A study will NOT be approved until the training requirement is met.
- A refresher course is required every 3 years.
Social Behavioral Training
- All investigators and study staff that will directly interact with a research subject or their PHI specifically for educational research purposes that are not within the clinical areas of the institution must complete the Social Behavioral Training course.
- A Social Behavioral refresher is not needed when you complete and/or maintain “Good Clinical Practice Training”. If not, a refresher course is required every 3 years.
- This requirement can be satisfied by completing all modules in the Social Behavioral CITI Training course.
- CITI Responsible Conduct of Research (only the following modules required from the RCR course )
- Introduction to the Responsible Conduct of Research
- Research Misconduct
- Data Management
- Peer Review
- Conflicts of Interest
- Collaborative Research
- CITI Health Information Privacy and Security (HIPS) for Clinical Investigators (only required for individuals who are not employed by MaineHealth, Maine Medical Center, or Maine Medical Partners).
- CITI Good Clinical Practice (GCP).
Responsible Conduct of Research (RCR) Training
- All students (undergraduates/graduate students) and postdoctoral scholars serving on studies funded by the National Science Foundation are required to complete a course on the Responsible Conduct of Research. Some NIH programs also require RCR training.
- This requirement can be satisfied by completing all modules in the “Responsible Conduct of Research” (RCR) course. CITI online training course.
The Responsible Conduct of Research (RCR) is only required for postdoctoral students funded by National Science Foundation or requested by your mentor.