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Essential Regulatory Do​cuments
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.​

 Information Sheets and Standards

For a complete list of DMID Information Sheets, Guidelines, and Standards, click here.

Regulatory Document Guidelines

Doc Icon     English - Source Documentation Standards ​​​
Version 2.0, Dated 01 September 2023​​​​​​​​​​
DMID Financial Disclosure Form with Instructions.pdf
DMID Investigator of Record Form.docx
DMID Investigator of Record Form Instructions.docx
DMID Language and Translation Requirements Summary.pdf
DMID Records Shipping for Retention Instructions.pdf
DMID Translation Equivalence Form (Appendix A).doc
Essential Regulatory Document Review Worksheet.docx

​Essential Regulatory Document Review Worksheet​

DMID CROMS Essential Regulatory Document Review Worksheet_v13 dated 2023-10-06.docx
DMID CROMS Essential Regulatory Document Review Worksheet_v14 dated 2024-01-25.docx
Essential Regulatory Documents Inventory List Template.xlsx
Investigator of Record Form For IDE.docx
CROMS ERDG Laboratory Information Sheet.pdf
Signature Responsibility List.docx