The site supplement protocol template is a resource template in the Toolkit to be used as a supplement to a main protocol that may not include all of the elements of the UW IRB template protocol. This will most likely only occur in multi-site studies. Study teams may choose to update the main protocol with any additional information requested by the IRB; however, the site supplement is another useful option to provide sufficient information for the IRB review.
Common examples of when this supplement template is helpful to study teams, or asked for by the IRB, include:
- Sponsor or coordinating center does not want changes to the main protocol, and
- UW site is not participating in all aims of the protocol, or
- UW is conducting an additional aim to the main protocol, or
- UW site recruitment procedures are not detailed or vary from other sites in the main protocol