Templates and Checklists

Protocol Development

DMID Study Product Protocol Template (28 May 2007)
DMID Study Product Protocol Template - Working Shell (28 Sep 2005)
DMID Specimen Protocol Template - Greater Than Minimal Risk (28 May 2007)
DMID Specimen Protocol Template Working Shell- Greater Than Minimal Risk (04 Nov 2005)
DMID Specimen Protocol Template - Minimal Risk (29 Sep 2004)
DMID Specimen Protocol Template Working Shell - Minimal Risk ( (28 Sep 2004)
Protocol Review Comment Form

Informed Consent Checklist
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.
NCI Informed Consent Template - Organizes informed consent in question and answer format.
DMID, NIAID Stored Specimen Consent Template - Suggested language for consent forms allowing storage of specimens.