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Protocol Development​​
Welcome to the DMID support page for Protocol Development, providing users with resources regarding DMID-supported research. This page contains protocol templates, formatting guides, procedural information, version control guidelines, and information on protocol deviation reporting.​

DMID Protocol Templates​

There are three types of protocol templates available:​
  • eCTD Compliant Interventional (required for all interventional protocols, pre-formatted)
  • Greater than Minimal Risk
  • Minimal Risk Sample Collection​​​

Interventional Protocol Template (eCTD compliant)

Use the eCTD compliant protocol template to write your protocol. You may reference the formatting tools and guidance section below for help in preparing eCTD compliant documents.


Formatting Tools and Guidance


Non-Interventional Protocol Templates and Working Shells

The Protocol Templates contain instructions and example text that can be included in your protocol. Use these templates as tools and not to draft your protocol. Use the working shells to write your specific protocol.

Greater than Minimal Risk definition

Minimal Risk Sample Collection definition

Protocol Template NEW!​​​​​

Version 1.0, Dated 29 September 2004

Protocol ​Working Shell

Version 1.0, Dated 28 September 2004


Protocol Document Submission

Contract-funded medium resource and all high resource protocols, amendments, informed consents, and other associated protocol documents must be submitted to the DMID-CROMS Document Library. Electronic versions of documents should be submitted to SIO@dmidcroms.com. To submit hard copy documents see information below:

Investigator Brochures must be submitted to SIO@dmidcroms.com or submitted directly to the DMID-CROMS Pharmacovigilance Group PVG@dmidcroms.com

Site-specific documents must be submitted to ERDG@dmidcroms.com; please see Essential Regulatory Documents.

Mailing Address:

                                                DMID-CROMS Study Information Office (SIO)
                                                         6500 Rock Spring Dr. Suite 650
                                                               Bethesda, MD 20817


Guidance and Tools​​

The documents below provide procedural information and tools for the DMID Clinical Project Manager.

  Note to File Guidelines​​

Version 3.0, Dated 9 July 2021

 Protocol Deviation Reporting​​

Version 3.0, Dated 06 September 2017​

 ​ Version Control Guidelines

​Version 2.0, Dated 20 March 2009

 Translation Equivalence (DMID form)​​​

 ​Resource Assessment Worksheet NEW!​​​​​

Version 2.0, Dated December 2008​


Additional Information

​  ​ Clinical Research Selected References under
  • FDA heading 21 CFR 50 for consents; 21 CFR 312 for INDs (Investigational New Drug); and 21 CFR 812 for IDEs (Investigational Device Exemption)
  • Human Subjects Protections heading for 45 CFR 46 for consent requirements
  • International Council for Harmonisation
  • Specimens page for Future Use of Specimens Guidance

 

Questions related to this page, please contact the CROMS Study Information Office at SIO@dmidcroms.com. For eCTD-related questions or issues, contact DMID-RASeCTD@tech-res.com and your associated Regulatory Affairs Specialist.​​​​​​​​