Protocol Development Tools |
Study |
Instructional TemplatesThese 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 ShellUse 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)
|
|
|