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Education Requirements

Collaborative Institutional Training Initiative (CITI)

All Baystate Health investigators and staff (or any member being added to the Baystate Health Core Data Form for an IRBNet submission), are required to complete the Collaborative Institutional Training Initiative (CITI) online training.

Please follow the chart below to determine what CITI trainings are required for you and your particular study. Please keep in mind that what is required for one study may differ than what is required for another but Biomedical will always be required. If you have questions on whether your study qualifies as a “clinical trial”, please view the NIH’s Definition of a Clinical Trial website to complete their walkthrough.

If you have an existing CITI account, please add (or affiliate) with Baystate Health. To do this, log in to CITI and select “Add Institutional Affiliation”. When adding this new affiliation, you do not need to remove any other affiliations. CITI will transfer any credits or applicable courses over to Baystate, so you do not need to complete the same trainings or modules twice. You are required to complete all modules required by Baystate Health prior to submission to IRB and ensure that your CITI certification does not lapse.

If you have any questions or issues with the CITI website such as logging in or transfer credits, please reach out to CITI support directly.

 Type of Project  CITI Training Required Explanation 
NIH Funded “Clinical Trial”
OR
Study involving an FDA Drug or Device
All members listed on the Core Data Form must submit current Biomedical and GCP CITI trainings. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

ICH E6 (R2) 1.24 Good Clinical Practice (GCP)
Sponsor/Internally Funded “Clinical Trial” Principal Investigator must submit current Biomedical and GCP CITI training. All other members listed on the Core Data Form must submit current Biomedical CITI training. ICH E6 (R2) 1.34 Investigator
Non “Clinical Trial” Studies All members listed on the Core Data Form must submit current Biomedical CITI training.  

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