Use of Pharmacy Investigational Drug Service - Institutional Review ...

Duke University Hospital Approved by: Pharmacy_SMG INVESTIGATIONAL
DRUG SERVICE
Department of Pharmacy Effective Date: 05/10 Investigational Drug Service
Expiration Date: 05/13
POLICIES & PROCEDURES Archived Date: 05/10 Page 1 of 3
I. POLICY
A. The Department of Pharmacy is responsible for the control of investigational drugs within
Duke Hospital. The Investigational Drug Service (IDS) is responsible for establishing studyspecific
procedures for appropriate drug accountability, billing, procurement, storage,
preparation, dispensing and destruction of investigational drugs within the hospital. These
procedures comply with local, state and federal requirements and are consistent with
Institutional Review Board standards, practice standards of the American Society of Health-
System Pharmacists and The Joint Commission on Accreditation of Healthcare
Organizations.
B. Investigational Drug Service personnel, along with the investigators, are responsible for
providing sufficient investigational drug information to medical, pharmacy, nursing and
other personnel providing care to research subjects. All pharmacists in the Department of
Pharmacy may be involved in some aspect of clinical research at Duke University Hospital
to provide continuity of care and shall work closely with the IDS team to ensure optimal
patient care. This may involve dispensing and/or preparation of study medication and/or
order entry.
C. Investigational Drug Service personnel assist physicians in obtaining investigational drugs
such as those with Orphan Drug status, Compassionate Use or Treatment IND status.
D. Investigational drugs administered to patients by Patient Care Services nurses are dispensed
from the Department of Pharmacy.
E. Investigational Drug Service personnel use safe medication practices to reduce the risk of
medication errors and adverse events.
II.
PROCEDURES
A. Investigational drugs are ordered, received, stored and dispensed for protocols that are
approved by the DUHS Institutional Review Board.
B. Investigational drugs are stored separately from other drugs in an area of limited access and
in accordance with special storage requirements. They are clearly labeled with the identity of
the compound, study title, investigator’s name, eIRB number and other control numbers.
C. Investigational drugs are accounted for using an Investigational Drug Accountability Record
(DAR). All drug transfers, receipts and disposal are recorded on the DAR. If required, IDS
will use sponsor specific forms.
D. Investigational drugs are dispensed subsequent to an order by an authorized prescriber.
Written orders include identification of the study and necessary prescribing information.
http://Pharmacy.mc.duke.edu

Duke University Hospital Approved by: Pharmacy_SMG INVESTIGATIONAL
DRUG SERVICE
Department of Pharmacy Effective Date: 05/10 Investigational Drug Service
Expiration Date: 05/13
POLICIES & PROCEDURES Archived Date: 05/10 Page 2 of 3
E. Unused Investigational drugs shall be returned from the nursing units to the Pharmacy for
disposal in accordance with requirements of the principal investigator, the sponsor and
applicable OSHA and EPA regulations. A Record of Destruction sheet (ROD) is used to
document disposal and destruction (incineration) following biohazardous waste procedures
unless other special procedures are required.
F. IDS is responsible for maintaining a study file containing the following for each study
protocol. All parts indicated as necessary will be prepared and placed in a study notebook
prior to study initiation:
FILE SECTION
Protocol
Drug Information
Pharmacy Procedures
memo
Logs/Forms/Labels
Shipping/Receiving
Correspondence
Computer Matters
Budget/Billing
IRB
Miscellaneous
IDS Master Subject Log
Drug Accountability Records
CONTENTS
A Copy of the research protocol, and IRB approved
delegation log
Investigator’s Brochure, Drug Data Sheet (DDS)
Package Inserts (if commercially available, other
relevant drug information) are available online
Only information relevant to the preparation, dispensing
or administration of the IP that is needed for IDS is kept
in the binder.
Study specific pharmacy procedures that outline the
necessary and important steps to prepare the medication
Study specific materials to document delegation, study
specific order forms, study specific labels
Receipt and disposition documents for IP
Important Correspondence relating to the study
Copies of activated HMM entry codes
Financial agreements with investigator
IRB submission, approval and consent forms are
available online and will only be kept in the study
binder if deemed important for that particular study
Record of all subjects enrolled who received IP
DAR for each drug/dosage-form package size
/strength/lot number/expiration date/temperature
G. Study specific notebooks are maintained in all pharmacy areas where study drugs are stored.
This notebook contains a copy of the Pharmacy Procedures Memorandum, DDS, DAR,
Master Subject Log and other necessary documents. All Investigational Pharmacy records
are consolidated and stored in accordance with regulatory requirements of study materials at
close-out.
http://Pharmacy.mc.duke.edu

Duke University Hospital Approved by: Pharmacy_SMG INVESTIGATIONAL
DRUG SERVICE
Department of Pharmacy Effective Date: 05/10 Investigational Drug Service
Expiration Date: 05/13
POLICIES & PROCEDURES Archived Date: 05/10 Page 3 of 3
H. Drug data sheets (DDS) are created for all Investigational New Drugs (IND) for inpatient
studies and are made available on the Pharmacy Extranet Website.
I. Pharmacy specific procedures are distributed to all dispensing locations and are available on
the Pharmacy Intranet Website.
J. Sponsored studies or Investigator-initiated studies that may have unsafe medication practices
will not be started at Duke Hospital. When the problem cannot be resolved between the
Investigator/Sponsor and the IDS, the unsafe practice is reported to the Chief Pharmacy
Officer and the IRB Chairman.
http://Pharmacy.mc.duke.edu