Updated Drug Brochures, DSUR, DSMB reports, and other Reports

When WCG IRB receives an updated Drug Brochure, prescribing information, DSMB report, or annual/final report, the IRB will review the submission and apply any resulting action automatically to all investigator sites associated with the affected protocol(s).

IRB approval indicates that the document has been reviewed and is on file for the research.

How WCG IRB Reviews Drug Brochures

Updated Drug Brochures should be submitted with a summary of changes. WCG IRB reviews the most complete version of the Drug Brochure on file at the time of submission. For example, if “Drug Brochure Version 17” is submitted but WCG IRB already has “Drug Brochure Version 17 with Addendum 1” on file, the IRB will document its review of the combined, most complete version. If an older version is submitted, the COA will not reflect approval of that older version, but will instead reference the newest version on file that the IRB relied upon in its review of the research. Drug Brochure addenda, indexes, annexes, errata, or similar documents are not reviewed as stand‑alone submissions — These materials are reviewed in combination with the associated Drug Brochure version on file, and the COA will reflect review of the combined document.

Submission of a DSUR (Development Safety Update Report) to WCG is optional unless it requires protocol or ICF updates related to risks in the DSUR. However, if mandated by the protocol, DSUR’s can be submitted as a full report or as a summary.