Do You Receive NIH Funding for Clinical Trials?
There is a new mandatory requirement, effective January 1, 2017 for NIH-funded investigators and staff who are involved with the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
Check your CITI training to ensure you’ve completed either the Good Clinical Practice (International Drug Research) – or – Good Clinical Practice (US only Drug or Device Research) modules.
For more detailed information, please view the links provided below:
- Notice of Policy on GCP training for NIH awardees involved in NIH-funded Clinical Trials
- NIH Definition of Clinical Trial
- List of NIH Institutes and Offices
- Q&A Regarding the NIH Definition of a Clinical Trial
CITI Training Requirements
Initial Submissions and Annual Reviews submitted to MMC-IRB after January 1, 2017 will 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:
- 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.
If you are working towards becoming certified as an Honest Broker you are required to complete the following modules in the “Responsible Conduct of Research” (RCR) course: CITI online training course.
- Responsible Conduct of Research Course Introduction (RCR ID 1522)
- Data Management IRCR Basic (ID 16600)
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.