Investigational Drug Service (IDS)

The VAMHCS Investigational Drug Service (IDS) provides services to investigators for conducting drug-related clinical trials involving patients at VAMHCS Baltimore. IDS pharmacists coordinate the distribution of study medications in compliance with FDA, GCP guidelines and within the framework of existing VA investigational drug and Department policies and procedures. In addition, IDS pharmacists assist investigators in the design of clinical trials, blinding and randomization of drug therapies, etc.

Any VAMHCS protocol that uses:

• investigational drugs,
• approved medications supplied by the Sponsor specifically for use in the study, or,
• investigational devices (when applicable)

In order for a protocol or applicable protocol amendment to be approved by the R&D Committee, the IDS pharmacist must approve the study. This is done by submitting pharmacy-related forms (see below).

The IDS is located within the inpatient pharmacy and can be reached at (410) 605-7113. Hours of operation are 7:00 a.m. to 3:30 p.m.

Further details can be found in the following documents:

Please note that forms listed below are to be printed and manually completed.

Standard Operating Procedures (SOPs)
SOP Number	Title	Appendixes/ Attachments
05.01	Research & Investigational Drugs (VAMHCS Research/Pharmacy SOP)	Clinical Trials Data Sheet Research Methods Accountability Form (RMAF) VA Form 10-9012 Pharmacy Fee Form Study Drug Dispensing Log

Forms
Title	Description	SOPs
Pharmacy Fee Forms	Required for R&D submission	01.03 01.04 05.01
Worksheet for Submissions to R&D Committee (Human Studies)	Required for R&D submission	01.03 01.04

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