As part of OASIS's ongoing collaboration with the DUHS IRB to increase automation, improve effectiveness, and support consistent documentation, all IRB outcome letters issued on or after August 15, 2026, will include standardized tables listing approved study documents (e.g., consent forms, protocols, Investigator's Brochures, and the iRIS application version, as applicable).
Document titles will appear exactly as entered by the study team in iRIS, while document version numbers and dates will be populated directly from the iRIS system. To ensure outcome letters accurately reflect submitted materials, study teams should enter document titles exactly as they wish them to appear on the IRB outcome letter. The IRB Office will no longer edit document titles unless an updated title is submitted as part of an amendment. This enhancement strengthens the connection between submitted and approved documents, reduces manual processing, supports regulatory compliance, and improves the consistency of IRB communications.
As part of this transition, continuing review outcome letters will no longer list historical documents approved under previous reviews. Instead, only documents approved as part of the current continuing review will be included in the document table. In addition, all continuing review outcome letters will include a statement confirming that any previously approved study documents that were not revised as part of the current continuing review remain in effect.