Welcome to the Investigational Drug Service (IDS)
The Investigational Drug Service (IDS) is a research pharmacy charged with the management of research medications used in clinical (human) drug trials, as well as the oversight of medication use in drug trials conducted throughout the University of Pennsylvania and its affiliates. Agents overseen by the IDS include drugs, natural products, vitamins, biologics and gene therapy agents. The IDS works only with clinical or non-clinical drug or device trials and does not prepare prescriptions for patients who are not participating in a study.
As a biomedical core and service center of the University of Pennsylvania School of Medicine and part of ITMAT, the IDS is entirely self-sustaining through user fees charged to investigators and/or study sponsors.
Contact the IDS once you have a general plan for your study; IDS personnel can provide input and recommendations, as well as estimate costs that you should budget for.
Important information by type of study:
|Type or Location of Patients||IDS Involvement||Comments|
|HUP Inpatients (Hospital of the University of Pennsylvania, 3400 Spruce St)||REQUIRED||All medications must be prepared/dispensed through IDS, or with IDS oversight. Studies that require 24/7/365 access to first doses, may require assistance by HUP pharmacy, but are still managed through IDS.|
|PMC Inpatients (Presbyterian Medical Center, 51 N. 39th St)||DEPENDS||The PMC inpatient pharmacy (215-662-8213) must be contacted. IDS will provide assistance to PMC on their request, or will coordinate with PMC when study activity involves multiple locations.|
|PAH Inpatients (Pennsylvania Hospital, 800 Spruce St)||DEPENDS||The PAH inpatient pharmacy (215-829-6540) must be contacted. IDS will provide assistance to PAH on their request, or will coordinate with PAH when study activity involves multiple locations.|
|CTRC (Clinical and Translational Research Center)||
HUP – YES
|The IDS works closely with the CTRC staff at both HUP (160 Dulles Bldg) and PMC (3 and 4 Mutch Bldg) to provide services for all trials, both inpatient and outpatient. For CHOP units (inpatient and 3535 Market St), primary services are provided by the CHOP research pharmacist (215-590-4470) with IDS assistance when needed.|
|Outpatients (on or off campus) – depends on activity:|
|Pre-packaged industry trials (dispensing only, no preparation or repackaging)||OPTIONAL||IDS may provide services for these trials on request, or when an unblinded 3rd party is needed. Clinics may manage these medications if they are stored, secured and labeled properly.|
|Repackaging||REQUIRED||IDS should be involved in the transfer of product into new containers, to ensure that proper accountability is done, proper labeling is applied, proper packaging is used and that the process is done in a clean environment.|
|Compounding or Manufacturing||REQUIRED||IDS must be involved whenever products are prepared from other materials.|
|Sterile Products||DEPENDS||Simple vaccinations or administration of pre-filled syringes may be suitable for handling in clinic (see above); anything more complex (including preparation of IV infusions or injections) must involve IDS.|
|Distribution to Other Sites||REQUIRED||IDS should be involved when medications are going to be distributed to other sites. Often there are other regulations – including state laws in the receiving state – that may apply.|
|Unrelated sites – including unaffiliated clinics or other institutions||OPTIONAL||IDS is able to provide some services to clinics or other institutions on request. External user fees, which include F&A (‘overhead’) costs which the university collects from IDS, generally apply.|