Initiation of IDS Involvement with a Clinical Drug Study
The Pharmacy IDS requires a copy of the Sponsor's protocol and Investigator's Drug Brochure. The Coordinator will review the protocol, meet with sponsor representatives, the principal investigator, and other study personnel to assess the potential IDS requirement.
An IDS budget can be developed for the investigator and the study staff to adequately plan for all necessary pharmacy costs in the study budget. Contact the IDS Coordinator if an itemized budget is needed.
Policy and Procedures
There is also an IRB Pharmacy Worksheet that needs to be filled out and submitted to the IRB with all other necessary materials.
Pharmacy manual and/or procedures guide is required prior to pharmacy study approval on IRBnet.