NEW Study Site Changes Form & Updated Modification Form

The UCSF IRB will release a brand-new iRIS form, the “Study Site Changes Form,” on Monday, May 13th, 2024. It will be released alongside an updated version of the Modification Form.

About the NEW Study Site Changes Form

This standalone form will be limited to site-related changes, and will allow the IRB to take a more targeted approach to identifying and processing site-specific modifications. Currently, these types of changes are submitted via the Modification Form.

Once this new form is released, please use it for all site-related changes, including:

  • Adding new UCSF-affiliated sites
  • Adding new outside sites (non-affiliated)
  • Closing a relying site
  • Removing a collaborating site that will not participate
  • Making other site-related changes, such as changing contact information for an outside site, etc.

About the Updated Modification Form

There are two main changes to the Modification Form that will be released on May 13th:

  1. Site Changes: Once the Study Site Changes Form is released, the UCSF IRB will no longer accept site-related changes on the Modification Form.
  2. Investigator’s Brochures: As announced in an April 4, 2024 bulletin, Investigator’s Brochures (IBs) must be submitted on the Modification Form. As such, the updated Modification Form will include a checkbox and a question field about whether a new IB is being submitted.

How will this affect my study?

  • If you start a modification submission prior to 5/13/2024: iRIS will provide you with the current Modification Form which allows site-related changes. You do not need to update it to the new forms, even if you submit it after 5/13/2024.
  • If you start a modification submission on or after 5/13/2024: iRIS will provide you with the updated Modification Form which does NOT allow site-related changes. If you are making site-related changes, you must submit them on the new Study Site Changes Form.

If you have questions about this bulletin, please contact the IRB office by submitting an Ask Andy form.