The Investigational Drug Services for Temple University is located at Temple University Hospital and is required to be used for all inpatient Investigational Drug Studies conducted at Temple University Hospital. All pharmacists have access to study drug and are trained in randomization procedures, preparation, documentation, and dispensing of study drug. Dispensing services are available 24 hours a day, 7 days a week.
Located: Inpatient Pharmacy (basement of Rock Pavilion)
Dispensing Contact Information 215 707-8280 pharmacy’s dispensing area (staffed 24/7)
Research Pharmacist – Christine Fitzgerald, Pharm.D. Ext. 215 707-9346
e-mail info: christine.fitzgerald@tuhs.temple.edu
The TUH Department of Pharmacy has established an Investigational Drug Service:
To provide safe and responsible handling of investigational drugs
To provide assistance and support to PI &/or Study Coordinator
To promote maximum benefit and safety for patients enrolled
Services Provided:
Protocol Assessment
Develop operational procedures with PI/Coordinator
Identify and resolve drug/pharmacy issues prior to first enrollment
Provide Drug Information
Provide Instruction for TDS/MIS drug order entry
Inpatient and Outpatient Study Drug Dispensing
Patient randomization
Drug dose adjustments
Drug preparation
Maintain inventory and drug accountability logs
Participation in Initial, Follow-Up, and Close-out Sponsor Site Visits
Fee Schedule available upon request
Primary Investigators/ Research Coordinators must:
1.
Complete and submit Investigational Drug Data Sheets (IDDS) for all inpatient and outpatient studies to the Research Pharmacist. (IDDS sheets can be downloaded from the IRB website)
IDDS Forms for inpatient studies are:
Taken to the Pharmacy & Therapeutics Committee for approval
Placed in patient charts as a communication tool
2.
Provide a copy of the Protocol and Investigator’s Brochure for all inpatient studies
3.
Involve the IDS in the dispensing of study drug for any patient that has been admitted to TUH or is receiving study drug in the Infusion Unit.
4.
Enter study drug orders into the TDS/MIS computer system for inpatient studies.
