Investigational Drug Service
The investigational pharmacists in the Investigational Drug Service (IDS) play a key role in facilitating subject safety for clinical trials being conducted at UMass Medical School (UMMS) and UMass Memorial Medical Center (UMMMC). The IDS has the following major roles and responsibilities:
- Consultation with investigators pre-study and throughout conduct of trial, including assessment of appropriate charges for investigational services;
- Preparation of IDDF (drug data form)
- Aiding in procurement of investigational drugs;
- Receipt, storage, accountability, dispensing and return/destruction of all investigational drugs
- Monitoring of all ongoing investigational drug activity by clinical researchers in the UMMS or on the campuses of UMMC;
- Control and accountability of investigational drugs according to state and federal regulatory requirements, sponsor specifications and hospital pharmacy practice
- With limited exception, UMMS/UMMMC policy requires that all drugs used for investigational purposes at UMMS/UMMMC must be stored, compounded and dispensed in the Investigational Drug Service pharmacy. Exceptions can only be made with advance approval by Investigational Pharmacy.
Location and Hours
- Location: Ambulatory Care Center – 6th floor, Satellite Service at Memorial Campus
- Hours: Standard hours of operations are 8:00 am-5:00 pm on weekdays with 24 hrs on-call service and support available after hours, holidays and on weekends.
For current IDS Policies and Budget Forms, please go to the IDS Policies website (intranet access only)
Support Service Pricing
The IDS is a cost-based support service. Investigators conducting research involving investigational drugs should ensure that their study budget sufficiently covers the costs of IDS support.
The support service pricing structure depends on the type of activity and the funding source as follows:
|Industry||Foundation||Federal (including federal flow-through)|
|Start-up||$4,500 + OH||$1,250 + OH||N/A|
|Per Patient Dispense||Variable||Variable||Variable|
|Monthly Maintenance||$75 + OH||$50 + OH||N/A|
|Closeout||$250 + OH||$250 + OH|
Additional costs for special protocol/handling considerations may apply.
To obtain pricing for clinical trial support services, send the study protocol and associated drug information to:
Investigational Drug Shipment
All investigational drug shipments from the sponsor to the site, whether or not they are to be stored in the pharmacy, will be received by the investigational pharmacist.
Direct shipments of investigational drug to:
Attn: Nitasha Sanil, RPh
UMass Memorial Medical Center
Ambulatory Care Center - Room AC6.058 (6th floor)
362 Plantation Street, Worcester, MA 01605
Clinical Research License Application and Renewal Assistance
Departments or Investigators who need to apply for, update, or renew clinical research licenses can contact IDS for assistance with the application and to obtain a list of studies/investigators.
Contact the IDS at:
Once the clinical research license renewal is complete, please direct a copy to Teresa Sousa in the CCTS Office of Clinical Research at Teresa.Sousa@umassmed.edu