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.
To meet the needs of IRB, you must take the 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.
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.
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:
- Log into CITI as you normally would.
- At the Main Menu, choose Click here to affiliate with another institution.
- Select University of Massachusetts Worcester as your Organization Affiliation.
- Back at the Main Menu, select University of Massachusetts Worcester Courses.
- Select Add a Course or Update Learner Groups.
- Select the relevant courses and submit:
- Group 1: Biomedical Research Investigators and Key Personnel for human subjects training
- REQUIRED: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) for the conduct of clinical trials as defined by NIH
- Within a given course, complete any module that is marked as incomplete or has a completion date that is older than three years.
- Once all modules in a course are marked as complete, CITI will automatically notify the UMMS IRB.
- Contact CITI directly with any login or credit transfer questions.
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.