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Protocol Development​

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 preparin​g 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

Protocol Template (eCTD compliant)​​

Version 3.0, Dated 26 July ​2010

Protocol Working Shell (eCTD compliant)

Version 1.0, Dated 04 November 2005

Minimal Risk Sample Collection definition

Protocol Template

Version 1.0, Dated 29 September 2004

Protocol ​Working Shell

Version 1.0, Dated 28 September 2004

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)

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; and 21 CFR 812 for IDEs
  • 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 For eCTD-related questions or issues, contact and your associated Regulatory Affairs Specialist.​​​​