Investigational Drug Services

Investigational Drug Services (IDS) supports all clinical drug-related research conducted by investigators at UVA Health. IDS provides the support needed to assure safe and efficient conduct of clinical drug trials, including compliance with federal, state, and Joint Commission requirements regarding investigational drugs. All inpatient studies are required by Hospital policy to use the IDS. Outpatient studies are strongly encouraged and may be required to use IDS.

Services provided:

• Assistance with protocol development
• Randomization schemes
• Blinding methodologies
• Development of educational materials/in-service training for patients and staff
• Preparation of oral, rectal, topical, and parenteral dosage forms and matching placebo
• Appropriate storage according to FDA guidelines
• Limited access and security of study drug
• Maintenance and control of investigational drug inventories
• Collection of all patient drug returns and reconciliation
• Maintenance of Drug Accountability Records and all study related files
• Participation in final close-out of the study protocol with the sponsor 
• Return of all used and unused study drug to the sponsor
• Drug destruction policies in place to destroy expired or used drug on site
• Participation in FDA, NCI, NIH and pharmaceutical sponsor audits
• Storage of all closed clinical study records for up to 15 years after closure
• Preparation of study specific physician order forms and order sets for inpatient and clinic orders
• Other special services as required