Essential Regulatory Documents Services
The Essential Regulatory Documents Group provides essential regulatory document tracking and review services to the DMID and their Partners for domestic and international protocols. Essential Regulatory Document Group Services include:
- Collect, review, transmit, and file Essential Regulatory Documents required for all stages of the study (Start-up, Interim, and Close out).
- Communicate with site to resolve essential regulatory document issues and/or obtain outstanding documents.
- Send Site Activation Memo to sites as notification that they can begin study-related activities.
If you have any questions or concerns, please contact DMID CROMS using the information provided below:
Sites conducting DMID clinical research must submit their essential regulatory documents to the CROMS Essential Regulatory Document Group (ERDG) for review and tracking. DMID document review guidelines have been developed in the form of a worksheet to assist CROMS ERDG, site staff, clinical site monitors and other DMID contractors in the review of essential regulatory documents.