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PRC Protocol Initiation (10.2)

PRC Protocol Initiation (10.2) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.2

POLICY & PROCEDURE





Effective Date:

August 2005
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:
Policy #: 10.2

Original
 Revision
09/14
Page 1
of 4

Title: PHARMACEUTICAL RESEARCH
CENTER PROTOCOL
INITIATION


I. PURPOSE: To establish a procedure for the initiation of clinical drug research protocols
within UWHC.

II. POLICY: The policy for initiation of a clinical drug research protocol establishes the
relationship between the Department of Pharmacy, the Health Sciences Institutional Review
Board (HS-IRB) and the principal investigator and describes the mechanism for making
investigational drug information available to UWHC health care providers.

III. PROCEDURE:

A. Mechanism for processing clinical drug studies within the institution.
1. All clinical drug research protocols conducted within UWHC will be
coordinated through the Pharmaceutical Research Center (PRC) as
mandated by Hospital Administrative Policy 4.27 “Investigational
and Study Drug Control”.
2. Investigators interested in conducting clinical drug research within
UWHC will contact the PRC as soon as possible and in advance of
contract negotiations and HS-IRB submission.
a. PRC will perform an initial review/feasibility assessment and
prepare a Pharmacy/PRC budget estimate.
3. The Manager of the Pharmaceutical Research Center (PRC) and the
Director of Clinical Research for UWHC and UWSMPH are voting
members of the HS-IRB and consequently will have knowledge of all
clinical drug research being conducted within the institution.
4. PRC will enter all UWHC clinical drug studies approved by the HS-
IRB into a database and generate monthly reports for distribution to
the UWHC Drug Policy Program
a. The Drug Policy Program will submit the aforementioned
monthly reports to the UWHC Pharmacy and Therapeutics
Committee for informational purposes
5. PRC will ensure that all clinical drug protocols submitted to the HS-
IRB and conducted within UWHC are subsequently conducted
within institutional policy and procedures governing study drug
control.

POLICY & PROCEDURE





Effective Date:

August 2005
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:
Policy #: 10.2

Original
 Revision
09/14
Page 2
of 4

Title: PHARMACEUTICAL RESEARCH
CENTER PROTOCOL
INITIATION


B. Mechanism for preparing a clinical drug trial for subject enrollment (“activation”).
1. To request clinical drug trial activation:
a. the principal investigator/study coordinator will contact the
PRC pharmacist directly and request protocol activation
(recommend a minimum of 4-6 weeks advance notification).
b. Information provided will include
i. IRB status
ii. Budgetary status
iii. Target subject enrollment date (to occur no sooner
than 10 business days after sponsor site initiation
visit if applicable).
2. Utilization of UWHC’s standard drug distribution system: All
clinical drug research agents (investigational and/or commercially
available) will be processed through the pharmacy department’s
standard drug distribution system whenever possible. Exceptions will
be dictated by the PRC and within institutional policy and
professional and regulatory standards. Exceptions may include
a. Use of PRC for drug preparation and/or distribution.
b. Use of study group (investigator/study coordinator) for drug
preparation and/or distribution provided: storage and
procedures approved by PRC; PRC has prior experience with
investigator/study coordinator; clinical location is not
supported by dedicated clinical pharmacist services or
specialty pharmacy; continuity of care within the UWHC
health system is not adversely interrupted; and other criteria
as applicable
i. PRC will approve protocol procedures, supply
necessary distribution labels, and may audit at any
time during the life of the protocol
3. Preprinted and/or Electronic physician orders/prescriptions will
be utilized whenever applicable and will follow institutional
requirements for multidisciplinary review in the required renewal
period.


POLICY & PROCEDURE





Effective Date:

August 2005
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:
Policy #: 10.2

Original
 Revision
09/14
Page 3
of 4

Title: PHARMACEUTICAL RESEARCH
CENTER PROTOCOL
INITIATION

4. Dissemination of individual protocol drug distribution
instructions: PRC will generate a “Protocol Summary” document
and make available to the Pharmacy Department via Pharmacy
Workspaces on U-Connect Information to include:
a. Principal investigator
b. Protocol objectives and treatment plan
c. Location of drug information (investigational monograph or
standard references)
d. Drug supply descriptions (source identification,
formulation/strength and storage location)
e. Procedures for requesting, preparing and dispending study
drug(s)
f. Procedures for drug accountability
5. Dissemination of investigational drug monographs: For
investigational drugs, PRC will generate an investigational drug
monograph document and make available to UWHC nursing and
other health care providers through U-Connect Workspaces.
a. Investigational monographs will be based on Investigator
Brochures (or equivalent information) and protocol
information
b. PRC Investigation Drug Monograph Information to include:
i. Caution statement for health provider use only (not to
be used as subject tool)
ii. Drug description and mechanism of action
iii. Pharmacokinetic information
iv. Adverse effects
v. Drug interactions
c. PRC will maintain only the current version of the
Investigator’s Brochure and will update the monograph with
each Investigator’s Brochure version and as new information
is obtained
d. Once a drug becomes commercially available the
investigational drug monograph will be removed from U-
Connect Workspaces


POLICY & PROCEDURE





Effective Date:

August 2005
 Pharmacy Policy Manual
Chapter: Pharmaceutical Research
Center
Operations Procedure Manual
Chapter:
Policy #: 10.2

Original
 Revision
09/14
Page 4
of 4

Title: PHARMACEUTICAL RESEARCH
CENTER PROTOCOL
INITIATION

6. Subject recruitment and enrollment: may begin only after the PRC
has completed protocol activation, study drug has been received or
ordered, applicable training/inservicing is completed, physician
orders are finalized (electronic or paper) and PRC is in receipt of a
copy of the current IRB approved protocol and associated approval.









Approved By: ____________________________
Director of Pharmacy Services


Date: ____________