Investigational Drug Services

The Investigational Drug Service (IDS), operated by the UI Health Care Department of Pharmaceutical Care, has been a participant in investigational drug studies for over 35 years. The primary goal of IDS is to assist and support principal investigators in meeting their obligations to study patients, the institution and research sponsors by ensuring that clinical trials are carried out safely, effectively and efficiently. Investigational Drug Services assures compliance with all federal, state, hospital, Joint Commission, and IRB regulations concerning investigation medications. Trials cover all phases of research and include industry sponsored, cooperative groups, and investigator-initiated studies. 

Services

Randomization & Blinding

Assistance in development of randomization schedules and maintenance of appropriate blinding as required.

Drug Storage

Drugs are stored in a limited access area, separate from all other drugs in the pharmacy accessible only to authorized personnel.

Drug Accountability

Proper ordering, receiving, storage, and maintenance of stock of all study drug materials.

Inventory Control

A perpetual inventory is maintained and drugs are physically counted each month.

Preparation

Sterile preparation of both hazardous and non-hazardous study medications in USP 797 + 800 compliant environments. 

Dispensing

Drugs are dispensed upon receipt of a prescription completed by an authorized prescriber.

Record Keeping & Retention

Accurate and proper records are maintained for all drugs received and distributed by the pharmacy. 

Epic

Utilization of Epic software for creation of drug files and treatment plans for investigational protocols.

For Faculty and Staff (for internal service)

Temperature & Storage Capabilities

• 24/7 temperature monitoring with TempTrak

Standard Operating Procedures

• RES-001 01 Investigational Drug Dispensing Procedures
• RES-002 Investigational Drug Services Training for Pharmacy Staff
• RES-NP002 Investigational Drug Temperature Monitoring and Actions for Temperature Excursions
• RES-NP003 Inventory Management of Investigational Products
• RES-NP004 Investigational Drug Internal Procedures from the IDS Pharmacy to Location within the Hospital
• RES-NP007 Investigational Drug Service Sponsor Personnel Expectations
• RES-NP008 Request for Waiver of UI Health Care Investigational Drug Service Standard Operating Procedures
• RES-NP010 Investigation Drug Documentation in Vestigo
• SUP-002-02 Investigational Product Disposal and Destruction
• Clinical Trial Standard of Care and Specialty Medication Procedures
• Additional Standard Operating Procedures and Standard Charge Sheet available by email request