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
Minimal Risk Sample Collection
Guidance and Tools
The documents below provide procedural information and tools for the DMID Clinical Project Manager.
Clinical Research Selected References
- 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
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.