Investigational Drug Service
The Clinical Research Unit's (CRU) Investigational Drug Service (IDS) provides full research pharmacy services to support clinical trials, including consulting services to develop pharmacy-related aspects of a protocol, a secured location for drug storage and dispensing, an Interactive Voice Response System (IVRS), subject randomization and blinding, and protocol adherence, such as drug counseling and drug accountability.
The IDS is staffed by full-time research pharmacists and pharmacy technicians who are available to directly assist investigators. The Unit is located on the 8th floor of the James W. Aston Ambulatory Care Center, directly across from the CTO. It features a clean room, or low-pollutant environment for the storage and preparation of medication for clinical trials, where air quality is constantly controlled. An anteroom annex is connected to the clean room.
The IDS also stores a limited amount of study binders and is equipped to facilitate study monitor visits with advance notice.
A brief summary of IDS services available to investigators includes:
- Initial receipt and inventory of investigational agents;
- Preparation and maintenance of drug accountability records;
- Meetings with investigators and study monitors;
- Preparation of protocol and drug information for pharmacy and study personnel;
- Inventory control and accountability audits;
- Ordering and maintaining drug stock;
- Monitoring visits;
- Storage and maintenance of returned drugs; and
- Study termination, reconciliation of drug accountability records, drug return, and maintenance of discontinued study pharmacy products.