AR 40-7 — Use Of U.s. Food And Drug Administration-regulated Investigational Products In Humans Including Schedule I Controlled Substances
AR 40-7 governs Army use of FDA-regulated investigational products, unapproved drug indications, and DEA Schedule I substances.
- Publication number: AR 40-7
- Title: USE OF U.S. FOOD AND DRUG ADMINISTRATION-REGULATED INVESTIGATIONAL PRODUCTS IN HUMANS INCLUDING SCHEDULE I CONTROLLED SUBSTANCES
- Date: 10/19/2009
- Proponent: TSG
- Status: ACTIVE
View AR 40-7 on armypubs.army.mil
It covers human and animal research, protocol approval and amendments, clinical trial monitoring, investigational product control, and emergency use. It requires compliance with FDA, DOD, and Army regulations and protection of human participants and research animals.
Topics covered
- FDA-regulated investigational products
- Human research protocols
- Investigational product control and handling
- Protocol amendments
- Emergency procurement from foreign suppliers
- Schedule I controlled substances
- Unapproved drug indications
Questions and answers
When can a clinical investigation begin after a new IND is submitted to the FDA?
Per FDA Form 1571, a clinical investigation cannot begin until 30 days after FDAs receipt of the new IND unless the FDA notifies the sponsor that the study may begin. (paragraph 2-9)
How often must an Institutional Review Board conduct continuing research review?
In accordance with 21 CFR 56.109(f), the IRB of record must conduct continuing review of research at intervals appropriate to the degree of risk, but no less than once per year. (paragraph 4-3)
What must investigators submit to the sponsor?
Investigators must furnish progress reports, safety reports, final reports, and financial disclosure reports to the sponsor (21 CFR 312.64). (paragraph 4-7)
Where should investigational products be stored in military treatment facilities?
In MTFs, the pharmacy is the appropriate location for investigational products. (paragraph 4-3)
What form must an investigator submit for nonclinical animal research with Schedule I controlled substances?
In order to conduct nonclinical animal research with Schedule I controlled substances, the investigator must submit DEA Form 225 along with three copies of the research protocol to the Drug Enforcement Administration, Department of Justice, P.O. Box 28083, Central Station, Washington, DC 200388083. (paragraph 6-1)