The IDS can support investigator-initiated trials, expanded access/named patient programs, and larger multi-centered trials. Services include:
- Protocol design assistance and feasibility review
- Acquisition of investigational treatments (IP) and placebo
- Receipt, Storage, and Final Destruction of IP
- Track expiration dates and re-test dates
- Dispensing of oral, topical, and injectable products
- Inpatient, outpatient, and infusion center
- Sterile preparation and distribution of hazardous and non-hazardous investigational products in a USP 797 compliant environment
- Integrity of blinding
- Continuous temperature monitoring of stored IP
- Maintenance of drug accountability and inventory records
- Discuss operating and IP costs with the Office of Sponsored Programs (OSP)
- Submit requests for Investigational product eRX in EPIC
- IP education and Huddle Helpers for clinical research staff and nursing
- IP review with study monitors
- Representation on the local IRB
