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/policies/clinical/uwhc-clinical/department-specific/pharmacy/pharmaceutical-research-center/1010.policy

20150115

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PRC Training and Competency (10.10)

PRC Training and Competency (10.10) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.10

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:

Policy #: 10.10

Original
 Revision 09/14
Page 1
of 2
Title: PHARMACEUTICAL RESEARCH
CENTER TRAINING AND
COMPETENCY


I. PURPOSE: To establish guidelines for the training and competency of PRC staff and for the
provision of educational instruction on topics relating to clinical drug research for health care
providers within and external to UWHC

II. POLICY: The PRC staff will provide training and competency opportunities to PRC and will
address the educational needs of other internal or external healthcare professionals as it relates to the
provision of pharmacy research support services and clinical drug research

III. PROCEDURE:
A. Training
1. PRC Staff
a. All new PRC employees will receive appropriate training for their designated
position description (refer to individual position description training manual
and/or training checklist).
b. All new PRC technicians and pharmacists will complete USP797-compliant
aseptic technique and oncology preparation training coordinated by the
Pharmacy Department’s Sterile Products Area (SPA).
i. PRC staff will be cleared for sterile products compounding after
successful completion of the required SPA PRC-modules and media fill
testing.
2. Pharmacy Department
a. Pharmacists
i. All new pharmacists at UWHC will receive training by PRC during their
orientation/training process.
ii. Training will include overview of clinical drug research at UWHC; PRC
role, staffing and 24/7 availability; new study notification process;
location of protocol and investigational drug information; handling of
compassionate use requests; applicable policies.
iii. Protocol-specific training will be reviewed as warranted.
iv. New CUD/SPA pharmacists will receive training on the SPA
accountability book and retrieving drug from the Control Area
v. New Oncology Clinic Pharmacists will be required to complete the PRC
competency and training document
b. Technicians

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:

Policy #: 10.10

Original
 Revision 09/14
Page 2
of 2
Title: PHARMACEUTICAL RESEARCH
CENTER TRAINING AND
COMPETENCY

i. New technicians employed in key research areas (SPA chemo; Oncology
Clinic) will receive training by PRC during their orientation/training
process as applicable.
ii. Training will be tailored specifically to the technician employment area
and will include protocol-specific training as warranted.

3. UWHC/UW Research Infrastructure Personnel
a. Study coordinators
i. As new study coordinators are identified within the research
infrastructure, PRC will invite the study coordinator to receive PRC
training.
ii. Training information will include overview of clinical drug research at
UWHC, PRC role, staffing and 24/7 availability; protocol activation
timelines and mechanism for submission of new protocols, budget
requests, changes of protocol, safety letter updates, updated Investigator’s
Brochure and adverse drug reactions (including Center for Drug Policy);
preprinted physician order institution requirements; patient notification;
patient returns; documentation of study coordinator responsibilities in the
PRC Protocol Summary.
b. Other individuals as needed
B. Competency
1. PRC Staff
The PRC program will maintain a competency plan in compliance with institutional
and departmental requirements and address basic aptitudes necessary to function
efficiently and effectively in the highly regulatory driven environment of clinical
research
C. Protocol Specific Training - See PRC procedure document titled “Pharmaceutical Research
Center Training Procedures – Protocol Specific


Approved By: ____________________________
Director of Pharmacy Services

Date: ____________