To request “Certification for pre-review of clinical data” from Privacy Board, complete a new application in eResearch Regulatory Management (eRRM). Fill out system-required sections, including:
- Question 1.8 (project summary): explain the purpose of the project, and why this requires access to PHI.
- Section 01-1: “Activities Not Regulated…”;
- Section 04-1: “Pre-review of Clinical Data Sets”;
- Section 25-3: provide required assurances.
Once completed and submitted, the application will be reviewed by IRBMED Staff for clarity and completeness, then assigned to an IRBMED Board reviewer for determination.