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PRC Protocol Closure (10.6)

PRC Protocol Closure (10.6) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.6

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.6

Original
 Revision 9/14

Page 1
of 1
Title: PHARMACEUTICAL RESEARCH
CENTER PROTOCOL CLOSURE


I. PURPOSE: To establish a procedure for the closure of a clinical drug research protocol.

II. POLICY: This policy will provide guidelines by which the PRC staff will close a protocol
involving research drugs and/or supplies

III. PROCEDURE:
A. Mechanism for closing a study:
1. Upon notification or verification from the principal investigator/study
coordinator that a study has closed, the Research Specialist will:
a. Complete a Closed Protocol Checklist form.
b. Complete a PRC Audit Preparation Form to verify accuracy and
documentation of the accountability record.
B. Mechanism for determination of final drug disposition:
1. The Research Specialist will determine (with the sponsor if applicable), final
drug disposition based upon specific protocol requirements.
2. PRC’s standard operating procedures are to request sponsors to ship remaining
unused drug(s)/supply(s) to their final disposition designee. Exceptions will be
determined on a per protocol and per study agent basis.
3. For information regarding local waste stream of used/partial containers, refer to
Administrative policy #5.27
C. Mechanism for long-term retention of study records:
1. All study records, including Drug Accountability Records, shipment package
slips, and correspondence will be kept in the PRC protocol folder in the PRC
closed file for duration of time consistent with sponsor requirements and federal
regulations.
2. PRC will retain all original copies of the drug accountability records and package
invoices within the protocol file. In the event the sponsor requires the originals
to be retained by the principal investigator or by the sponsor/designee, PRC will
retain a copy of such documents for the protocol file. PRC will then generate a
note to file stating where the original drug accountability records are being
retained and by whom, and also list the person who requested this.


Approved By: ____________________________
Director of Pharmacy Services

Date: ____________