DMID Templates and Checklists
The protocol templatesand working shells listed below, along with other resources can be found on the DMID Protocol Development Tools web page.
- DMID Study Product Protocol Template
- DMID Study Product Protocol Template - Working Shell
- DMID Specimen Protocol Template - Greater Than Minimal Risk
- DMID Specimen Protocol Template Working Shell- Greater Than Minimal Risk
- DMID Specimen Protocol Template - Minimal Risk
- DMID Specimen Protocol Template Working Shell - Minimal Risk
- Protocol Review Comment Form
- Informed Consent Checklist - DHHS requirements for informed consent (45 CFR 46). Includes required basic elements, additional elements that may be necessary, conditions under which written informed consent can be waived, and requirements when oral informed consent is used.
Quality Management Policy, Guidance and Tools can be found at: DMID Clinical Research Policies and Standard Procedure Documents, Quality Management
Quality Management form, templates and tools can be found on the DMID CROMS website.