INITIATION OF A CLINICAL DRUG STUDY
The investigator or study coordinator will send a copy of the Sponsor’s protocol, Investigator’s Brochure, and any other relevant documents to the research pharmacists. The research pharmacist will review the protocol, meet with sponsor representatives, the principal investigator, study coordinator, and other study personnel to assess the potential IDS requirements. IDS will prepare dispensing instructions, develop drug fact sheets, create EPIC order sets, assist with Beacon treatment plan development, and create other documents or activities as required by the study.
In general, Main IDS (non-Cancer Center) studies take approximately 4-6 weeks to set up with pharmacy, depending on the needs of the study. Please be aware of this time frame when coordinating study start-up.
COST OF USING THE INVESTIGATIONAL DRUG SERVICE
See the Pharmacy Intranet for UVA IDS fees (UVA personnel only)
STUDIES REQUIRED TO USE INVESTIGATIONAL DRUG SERVICES
Per medical center policy and Joint Commission standards, any study in which an investigational drug agent is administered to a patient at UVA Medical Center or its affiliated clinics must have drug dispensed by IDS. Fully outpatient studies (all drug is administered away from medical center/clinics) must have drug dispensed by IDS unless the drug is labeled for end use by the sponsor, in which case, use of IDS is strongly recommended, but not required. If the study is not utilizing IDS, the study must be registered as such with the IRB. Contact IDS via email if you have questions regarding these requirements.
Looking for the IDS waiver for IRB? Click here to access the Pharmacy Intranet page, and scroll to the bottom.