Investigational Drugs and Devices

Investigational Drugs

VA regulations require that drugs used for research studies (including FDA approved drugs) be handled by the VA Research Pharmacist.

PI's must adhere to a detailed set of procedures when using the VA Pharmacy, both before and during the study, which are helpfully outlined in the "Management of Investigaitonal Drugs Procedure" at http://www.atlanta.va.gov/services/research/Investigators.asp (see the "Investigational Drugs" section).

As part of those procedures, each study that involves the pharmacy must complete and submit an Assessment of Pharmacy Impact form and Investigational Drug Information Record to the Science Information Officer. These forms can be found at: http://www.atlanta.va.gov/services/research/Investigators.asp. Both must be approved as part of the R&D Committee submission process.

For information regarding VA Drug Handling policies and procedures, contact the research pharmacist at (404) 321-6111, ext 4214.

Investigational Devices

The AVAMC also has specific policies and procedures for Investigational Devices, described in documents found at http://www.atlanta.va.gov/services/research/Investigators.asp, under "Investigational Devices and Investigational Tissue Products"