KEY NOTES: 

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:

1. Log into CITI as you normally would.
2. At the Main Menu, choose Click here to affiliate with another institution.
3. Select University of Massachusetts Worcester as your Organization Affiliation.
4. Back at the Main Menu, select University of Massachusetts Worcester Courses.
5. Select Add a Course or Update Learner Groups.
6. Select the relevant courses and submit:

1. For human subjects training: Group 1: Biomedical Research Investigators and Key Personnel.
2. For GCP training, if applicable, choose one:

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

7. Within a given course, complete any module that is marked as incomplete or has a completion date that is older than three years.
8. Once all modules in a course are marked as complete, CITI will automatically notify the UMass Chan IRB.
9. 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. 

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
period, after which time a refresher course or additional training must be completed. 

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 UMass Chan requirement.

▢ GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - This course meets the UMass Chan requirement and the minimum criteria for ICH GCP Investigator Site Personnel Training
identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

▢ NIH - Social & Behavioral Research Best Practices for Clinical Research - This course meets the UMass Chan 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 UMass Chan" Brochure for more information, including instructions on how to access and complete
the GCP training requirement.