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.

Budget

An IDS budget will be developed for the investigator and the study staff to adequately plan for all necessary pharmacy costs in the study budget. Unless the IDS is presented with proposed changes, the IDS budget is assumed to be accepted as the pharmacy budget for the study protocol. An invoice will be sent to the study coordinator.

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.