DMID Clinical Research Policies and Standard Procedure Documents

Protocol Development Tools
Study	Instructional Templates These instructional template tools contain instructions and suggested text that can be included in your draft protocol. Refer to the Protocol Development Guidance and the Working Shell to draft your protocol.	Working Shell Use these shells to draft your protocol. Refer to the Instructional Template tools for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol.
Interventional	DMID Interventional Protocol Template (MS Word)	DMID Interventional Template: Working Shell (MS Word)
Greater Than Minimal Risk	DMID Specimen Protocol Template: Greater Than Minimal Risk (MS Word)	DMID Specimen Protocol Template: Greater Than Minimal Risk Working Shell (MS Word)
Minimal Risk	DMID Specimen Protocol Template: Minimal Risk (MS Word)	DMID Specimen Protocol Template: Minimal Risk Working Shell (MS Word)

Protocol Development Guidance
ICH E6 GCP	http://www.ich.org/cache/compo/475-272-1.html#E6
Version Control	Version Control Guidelines (MS Word)
Study Population	Healthy Volunteer Eligibility Policy (PDF)
Document Translation	DMID Translation Policy (PDF) and tools (MS Word) DMID Translation Equivalence Form (Appendix A) (MS Word) DMID Language and Translation Requirements Summary: Essential Document Requirements and Instructions (Appendix B) (MS Word)