The IDS is responsible for the safe handling of investigational drugs. The purpose of the IDS is to maintain control and accountability of investigational drug use in the Medical Center to promote maximum benefit and safety for patients enrolled in studies.

Investigational drugs are procured, stored, inventoried, dispensed and used through the IDS in compliance with applicable federal, state, local and institutional laws, regulations, policies  or guidelines.  

Services provided for all research protocols:

  • Drug procurement.
  • Secure, Monitored Storage (there are specific guidelines for storage/security).
  • Accountability (for all agents received and disbursed, accurate to the individual dose).
  • Preparation (includes sterile preparation if necessary).
  • Labeling and Dispensing.
  • Meets with study team as needed.
  • Meets with sponsor and sponsor's representatives to review protocol and records.
  • 24-hour on-call for study-related issues.

Services provided as necessary based on the needs of the trial:

  • Randomization tables (and un-blinding envelopes for off-site clinics).
  • Repackaging (e.g. bottles, cartons, boxes).
  • Compliance packaging (e.g. blister cards, unit-of-use containers, special labeling).
  • Sterile compounding.
  • Non-sterile compounding (over-encapsulation of commercial products, compounding of powders or liquids, placebos, suppositories, etc).

Other services available include:

  • Consultation on study design and logistics.
  • Research of protocol-related questions.
  • Assistance with IND application development.

Protocol development:

If you are developing a protocol, please contact the IDS during the planning stages, particularly for investigator-initiated or NIH-Sponsored projects. The IDS can provide valuable input and evaluate the feasibility and costs of a trial prior to completion. Projects that are developed without IDS input may require amendments once the IDS has reviewed them.

The IDS is dependent upon investigator’s reimbursement of its costs as revenue for continued operations. The IDS does not receive financial support from the University or Health System. The IDS cannot provide services to investigators or departments which are not reimbursing the IDS for its costs of participation in their research.