Changes to April 17th Bulletin

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On April 17th, the IRB issued a bulletin announcing a New Study Site Changes Form & Updated Modification Form that would be released on Monday, May 13th. We received valuable stakeholder feedback in response to that bulletin, and are changing the plan as follows:

April 17th Bulletin Announcements

New Plan
  1. A new “Study Site Changes” form is being created to capture all site-related changes.
  1. The new form will be specific to one type of site-related change: Adding a relying site (i.e., an external study site that will rely on the UCSF IRB). This form will be called the “Add Relying Site” form.
  1. The Modification form will no longer accept any site-related changes. 
  1. All other site-related changes will continue to be submitted on the Modification Form. Examples include:
  • Adding UCSF and UCSF-affiliated sites
  • Adding external sites that are not relying on UCSF’s IRB
  • Closing a relying site 
  • Changing contact information for a study site

 
  1. The new and revised forms were going to be released on May 13th.
  1. No changes will be implemented on May 13th. We will keep you posted about when the new and revised forms will be released.

Note: Study teams do not need to take any actions in response to this bulletin. 

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