Use of U.S. Food and Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances
This major revision, dated 19 October 2009–
o Changes the title of the regulation to Use of U.S. Food and Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances.
o Implements DODD 3216.1, DODD 3216.02, and DODI 6200.2 (paras 1-5c, 1-5e, 2-2d, 4-1b, 4-4b(1), 4-5b(1), and 5-6).
o Updates information pertaining to clinical investigation protocols that use U.S. Food and Drug Administration-regulated investigational products (para 1-5d).
o Realigns and adds responsibilities relevant to the U.S. Army’s use of U.S. Food and Drug Administration-regulated investigational products (chap 2).
o Identifies the required protocol approval and protocol submission requirements (chap 3).
o Reviews the nature of the U.S. Food and Drug Administration regulations and standards of regulated investigational products (chap 3).
o Reviews procedures for conduct of clinical research studies by Good Clinical Practice Standards and places them in one chapter (para 4-1).
o Adds sponsor responsibilities and timelines for reporting serious and unexpected adverse events associated with the use of investigational products to participating investigators and the U.S. Food and Drug Administration (para 4-4).
o Adds the responsibilities of the medical monitor as defined in DODD 3216.02 (para 4-5).
o Identifies exceptions to routine research uses of U.S. Food and Drug Administration-regulated investigational products (chap 5).
o Adds procedures related to the emergency use of an investigational new drug and unapproved devices (para 5-4).
o Outlines the uses and references of Schedule I controlled substances (chap 6).
o Includes information on the control of investigational drugs used to treat patients moving among U.S. Army Medical Centers and U.S. Army Medical Department Activities (app B).
o Includes general information on the regulation of medical devices (app C).
o Includes a Management Control Checklist (app D).
o Replaces the term, “investigational drugs and devices” with “U.S. Food and Drug Administration-regulated investigational products” which includes biologics (throughout).
o Makes administrative changes (throughout).