10/23/2023 4:49:06 PM
Updated DMID eCTD Interventional Protocol Template, Resources and Timeline documents Available
Dear DMID Stakeholders and Collaborators: The updated DMID eCTD Interventional Protocol Template was added to the Protocol Development page. In addition to the updated template, some support documents were also added: eCTD IND Templates And Resources, eCTD Submission Requirements – What You Need To Know, Timeline for Commercial IND Application Submission — Including eCTD Compliance and Publishing Activities, Timeline and Flowchart for IND Document eCTD Formatting Compliance Assessment, and Timeline and Flowchart for IND Finalization, Compilation, Publishing Activities and Submission. These documents include information regarding templates and resources available to assist with eCTD compliance of IND documents, general information on eCTD submission requirements, and flow charts to illustrate the timelines for eCTD formatting, IND finalization, publishing, and submission to the FDA. For any questions, please contact DMID-CROMS Study Information Office at SIO@dmidcroms.com.