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PRC Secondary Protocols (10.9)

PRC Secondary Protocols (10.9) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.9

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.9

Original
 Revision
09/14
Page 1
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER SECONDARY
PROTOCOLS


I. PURPOSE: To establish procedures for the activation, storage, maintenance and closure of
Secondary Protocols.

II. POLICY: The Pharmaceutical Research Center (PRC) will provide assistance and oversight
for Secondary Protocols assuring that these protocols comply with applicable institutional
standards and regulatory requirements.

III. DEFINITIONS:
A. “Secondary Protocols” is a broad PRC classification used to describe protocols where
some or all of the elements of drug handling (ordering, receipt, storage, distribution,
final disposition) have been delegated by PRC to the general Pharmacy Department
or Investigator. Subcategories include:
1. Formulary Protocols – in this category, elements of drug handling have been
delegated to the UWHC Department of Pharmacy. There is no research-
supply of drug or supplies and no provision of free drug to the subject.
Formulary drug codes, inventory are utilized with billing to the subject and/or
their insurance provider per standard of care.
2. Investigator/Clinic Delegated Protocols – in this category, elements of drug
handling have been delegated to the Investigator. PRC will make this decision
on a protocol per protocol basis and after careful consideration of the protocol
requirements, experience of the investigator and the physical location of
his/her practice, existence of experienced supportive research staff,
appropriateness of storage facility/equipment, the continuity of care of the
research subject and other factors as necessary.
B. “Primary Protocols” is a broad PRC classification used to describe the vast majority
of UWHC protocols where no delegation of drug handling outside of the PRC has
occurred. Preceding policies were written from a Primary Protocol perspective except
where noted.

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.9

Original
 Revision
09/14
Page 2
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER SECONDARY
PROTOCOLS


IV. PROCEDURE:
A. Investigator/Clinic Delegated Protocols
1. Approval and activation
a. Upon receipt of a protocol and request for Investigator/Clinic Delegated
consideration, the PRC Pharmacist will review the protocol, investigator
qualifications, supportive research staff and proposed research site and
make an initial determination of Investigator/Clinic Delegated
appropriateness.
i. In the event the protocol is judged not to be appropriate
for Investigator/Clinic Delegated status, the protocol will
be processed as a Primary Protocol.
b. The PRC Pharmacist will forward the initial Investigator/Clinic
Delegated recommendation to the PRC Research Specialist for
assessment of storage location/equipment and confirmation of
appropriateness.
i. In the event the protocol is judged not to be appropriate
for Investigator/Clinic Delegated status, the protocol will
be processed as a Primary Protocol.
c. Once Investigator/Clinic Delegated status has been awarded, the PRC
Business Operations Specialist will register the protocol into the PRC
Investigator/Clinic Delegated database which includes investigator,
study coordinator and sponsor names, location of study, and Health
Sciences Institutional Review Board (IRB) number.
d. The PRC Business Operations Specialist will update the database on a
monthly basis. Any study which has recently received IRB approval
will be flagged for follow-up and/or activation.
e. The PRC Research Specialist or Business Operations Specialist will
contact staff to determine date of study initiation and/or first patient
enrollment, receipt of initial study drug shipment, and labeling
requirements.
f. Once the initial study drug shipment has been received and before it
has been dispensed, the PRC Research Specialist will set up a PRC
site visit with the study coordinator.


POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.9

Original
 Revision
09/14
Page 3
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER SECONDARY
PROTOCOLS

2. Maintenance and auditing
a. Investigator/Clinic Delegated protocols are subject to audit by PRC at
any time. The PRC Research Specialist will utilize the Secondary
Clinic Protocol Audit Sheet to obtain information in the following
areas:
i. Patient Informed Consent
ii. Dispensing records for investigational/study drugs
iii. Authorized Prescribers
iv. Labeling and packaging of investigational/ study drugs
dispensed
v. Audit of investigational/study drug supply (inventory,
expiration dates)
vi. Storage and security of investigational/study drugs
vii. Availability of study drug information.
b. The Research Specialist will address any deficiencies with the study
coordinator. Any outstanding deficiencies will be addressed with the
PRC Manager.
3. Closure
a. Upon receipt of notification of study closure, the PRC Research
Specialist Will note in the appropriate database and complete file
closure.
B. Formulary Protocols
1. Approval and activation
a. The PRC Pharmacist will review all Formulary Protocols and
determine the need for PRC generation of Pre-Printed Physician
Orders or orders built within the Electronic Environment.
b. PRC Pharmacists will Work with the study group/coordinator to draft
and finalize the orders per institutional policy.
c. The protocol, all changes of protocol and copy of the Pre-Printed
Physician Orders will be maintained in the PRC.
d. Formulary Protocols will be registered in the Formulary Protocol
Database.
2. Maintenance and auditing

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.9

Original
 Revision
09/14
Page 4
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER SECONDARY
PROTOCOLS

a. PRC Pharmacist will review all protocol amendments received and
determine the impact on existing Preprinted or Electronic Physician
orders.
i. In the event a change of protocol reverses the Formulary
Protocol status (the new provision of free study supplies,
etc), the protocol will be converted to a Primary Protocol and
handled per Primary Protocol procedures.
ii. Protocol amendments will be saved and filed with the
protocol in PRC.
b. Review of Pre-Printed or Electronic Physician Orders will be
performed per institutional policy.
c. The PRC Research Specialist will review the Formulary protocol files
and corresponding database to determine the status of each study. The
database will be updated accordingly and studies that will not be
activated or have been closed/terminated will be purged from the
protocol files.
3. Closure
a. Upon receipt of notification of study closure, the PRC Research
Specialist will note the closure in applicable PRC databases.
b. The protocol, amendments, correspondences and physician order
templates will be destroyed per confidential institutional standards.


Approved By: __________________________
Director of Pharmacy Services

Date: ____________