Protocol and Research Summary Template Changes
The IRB has posted new versions of the Protocol and Research Summary templates.
Change 1: The title page of the Protocol and Research Summary templates now requests that contact information for the sponsor and CRO of a study be included. This will need to be revised for all applicable protocol and re4search summaries at a study’s next continuing review.
Change 2: Various sections throughout the Protocol and Research Summary templates now request information regarding the use of the Utah Population Database (UPDB). The RGE Committee will be using the IRB Protocol and Research Summary templates in their review for the use of UPDB. If this information is not provided in a current study’s protocol or research summary, it will need to be revised at the study’s next continuing review.
Change 3: The Administrative Responsibilities section now requests that contact information for participating sites be included with the IRB application for studies where the University of Utah is the lead site. This list does not need to be provided for multi-center studies where the University of Utah is not the lead site. This will need to be revised for all protocol and research summaries at a study’s next continuing review.
New templates have been posted on the IRB website. Tracked copies of these templates are posted as well in order for you to easily view the changes.
If you have any questions about these changes, please feel free to contact the IRB.