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10/12/2023 4:27:07 PM
Updated Essential Regulatory Document Review Worksheet Available

Dear DMID Stakeholders and Collaborators: This worksheet is to provide guidance for the completion, review, and maintenance of required essential regulatory documents and incorporates the requirements and guidelines referenced in ICH GCP Guidelines, DMID Regulatory File Document Guidelines, 45 CFR 46, 21 CFR 50 and 21 CFR 312. This includes updates on new DMID requirement to collect all Sub-I Medical Licenses. For any questions, please contact DMID-CROMS ERDG at ERDG@dmidcroms.com
Title
Body
Expires
Announcement Type
Attachments