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20150115

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PRC Goals and Objectives (10.1)

PRC Goals and Objectives (10.1) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.1

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: PRC
Operations Procedure Manual
 Chapter:

Policy #: 10.01

Original
Revision 09/14

Page 1
of 2
Title: PHARMACEUTICAL RESEARCH
CENTER GOALS AND OBJECTIVES


I. PURPOSE: To define the goals and objectives of the Pharmaceutical Research Center (PRC).

II. POLICY: The Pharmaceutical Research Center is responsible for coordinating and overseeing
all clinical drug research conducted within UWHC facilities. The Pharmaceutical
Research Center will do this in a manner consistent with federal regulations,
applicable accreditation organization(s), institutional and professional standards and
sponsor stipulations.

III. PROCEDURE:
A. The Pharmaceutical Research Center goals and objectives are to:
1. provides administrative, regulatory and clinical services to investigators conducting
research at UWHC;
2. assist investigators in protocol and research design evaluation and/or development
and randomization activities (if within scope of PRC feasibility);
3. activate and maintain protocols in compliance with all applicable regulations;
4. provide and maintain a protocol and investigational drug information database;
a. protocol summary document shall include but is not limited to, the
following:
i. study design
ii. treatment plan
iii. location of drug information
iv. drug distribution procedures
v. accountability
b. drug monograph document shall include, but is not limited to, the
following:
i. agent description and mechanism of action
ii. pharmacokinetics
iii. adverse effects
iv. drug interactions
5. maintain drug ordering, inventory, accountability, and recordkeeping activities for
each individual protocol;
6. provide a continuous quality improvement program to assure proper compliance with
all federal regulations, accreditation organizations, professional standards and
institutional policy(s) and sponsor stipulations;
7. assist with compassionate use requests and Treatment Investigational New Drug
(IND) applications;
8. develop PRC protocol budgets;
9. continually interface with the following research services:
a. the Health Sciences Institutional Review Board

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: PRC
Operations Procedure Manual
 Chapter:

Policy #: 10.01

Original
Revision 09/14

Page 2
of 2
Title: PHARMACEUTICAL RESEARCH
CENTER GOALS AND OBJECTIVES

b. Office of Clinical Trials
c. Clinical Research Unit (CRU)
d. UW Carbone Cancer Center and
e. UW School of Medicine and Public Health
10. assures patient safety in the conduct of clinical drug trials at UWHC through
improved research drug distribution procedures;

11. minimize problems with the availability, preparation, and storage of study drugs;
12. whenever feasible, integrate the distribution of study drugs with the established
system at UWHC thereby reducing the cost of handling study materials and
maintaining consistent processes
13. provide assistance and oversight for the implementation and maintenance of
protocols conducted outside of PRC handling;
14. maintain database of all drug protocols and compassionate use applications approved
by the Health Sciences IRB and generate/submit report to the Drug Policy Program
for eventual reporting to the Pharmacy and Therapeutics Committee
15. if fiscal or reimbursement issues arise, forward the protocol and background
materials to the UW Research Billing Compliance Committee;
16. provide training and educational programs to pharmacy staff (pharmacists and
technicians), pharmacy residents and pharmacy students;,
17. provide training to research staff including study coordinators, new principal
investigators and visiting research professionals.



Approved By: ____________________________
Director of Pharmacy Services

Date: ____________