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UWHC,

Policies,Administrative,UWHC,UWHC-wide,Legal Affairs

Investigational and Study Drug Control (4.11)

Investigational and Study Drug Control (4.11) - Policies, Administrative, UWHC, UWHC-wide, Legal Affairs

4.11

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Administrative (Non-Clinical) Policy
Category:
 UWHC only (Hospital Administrative-entity wide)  UWMF only (entity wide)
 UWHC Departmental (indicate name)  UWMF Departmental (indicate name)
 UWHC and UWMF (shared)
Policy Title: Investigational and Study Drug Control (policy used by UWHC,
UWMF and UWSMPH)
Policy Number: 4.11
Effective Date: September 1, 2015
Chapter: Legal Affairs
Version: Revision
I. PURPOSE

To establish a uniform procedure for the coordination and control of drugs (regardless of investigational
or commercial status) used in clinical research in accordance with federal regulations, applicable
accreditation organizations, institutional and professional standards and sponsor stipulations. (For
Compassionate Use of an Investigational Agent or Use of an Investigational Agent from a Second
Institution see Hospital Administrative policy-4.27.)

II. DEFINITIONS

The term study drug will be used throughout this policy to describe drugs, both investigational and
commercially available, being tested or studied as part of a clinical drug research protocol. An
investigational drug is defined as a drug that does not yet have Food and Drug Administration (FDA)
approval for commercial use and is available for research purposes only, usually under an Investigational
New Drug (IND) application.

The term IRB (Institutional Review Board) is used when referencing federal regulations in general. The
HS-IRB is the UW Health Sciences IRB. "Other Approved IRB" refers to the other IRBs that may serve
as an IRB of record on the UW Health Entity’s behalf (for example the National Cancer Institute’s
Central Institutional Review Board or Western Institutional Review Board, both of which are utilized by
UWHC, UWMF and UWSMPH).

III. POLICY

This policy defines the relationship between the Pharmacy & Therapeutics Committee (P & T) and the
HS-IRB and Other Approved IRBs as well as the procedural steps for satisfaction of study drug control
requirements. It is the policy of UWHC, UWMF and UWSMPH that study drugs, as a part of a clinical
drug research protocol, not be used in subjects unless regulatory approval has been obtained from the HS-
IRB or Other Approved IRB. IRB approval is protocol-specific and of a specified duration at which time
re-approval can be granted based on IRB continuing review assessment.



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IV. FORMS

The HS-IRB uses an electronic protocol submission and tracking system called ARROW, which is
available at www.arrow.wisc.edu/irb. IRB guidelines and submission instructions for Other Approved
IRBs are available on the HS-IRB website at https://kb.wisc.edu/hsirbs/.

V. PROCEDURE
A. Mechanism for obtaining HS-IRB or Other Approved IRB approval for use of study drugs.
1. The HS-IRB or Other Approved IRB is charged with reviewing and approving research
protocols involving the use of study drugs for UWHC, UWMF and UWSMPH
Investigators.
2. The investigator submits a research protocol and an application for review per HS-IRB or
Other Approved IRB instructions.
3. The HS-IRB has one member (Pharmaceutical Research Center pharmacist) who reports
clinical drug research protocols deemed approvable by the HS-IRB to the Pharmacy and
Therapeutics Committee (P & T Committee). The Pharmaceutical Research Center
pharmacist will be in receipt of clinical drug protocol approval notices awarded by Other
Approved IRBs and will also report these protocols to the P & T Committee.
4. The HS-IRB or Other Approved IRB must approve the protocol and consent procedures
before a study drug can be released to the investigator or used in research subjects at
UWHC, except for Emergency Use of an Investigational Agent in one Patient or for Use
of an Investigational Agent from a Second Institution when permitted under UW Health
Hospital Administrative policy-4.27.
B. General responsibilities of UWHC, UWMF and UWSMPH investigators conducting clinical drug
research
1. An investigator is responsible for ensuring that research is conducted according to the
signed investigator statement (FDA Form 1572), the investigational protocol, and
applicable regulations.
2. An investigator is responsible for protecting the rights, safety and welfare of subjects
under the investigator's care.
3. An investigator is responsible for the control of study drugs used in a research project in
accordance with federal, sponsor, and institutional policy.
4. An investigator, or his or her designee, is responsible for obtaining the informed consent
of each human subject or the authorized representative to whom the study drug is
administered.
5. An investigator is responsible for ensuring study drug is administered only to subjects
under the investigator's personal supervision or under the supervision of a sub-
investigator responsible to the investigator.
6. An investigator is required to comply with all requirements pertaining to disposition of
drug, case histories, record retention, progress reports, safety reports, and assurance of
IRB review as stipulated in the federal regulations.
C. Study Drug Control Requirements - UWHC
1. All UWHC clinical drug research protocols must be coordinated through the Pharmacy
Department's Pharmaceutical Research Center (PRC). Investigators conducting clinical
drug studies must contact PRC (263-8863) in advance for each clinical drug research
project to obtain an institutional feasibility assessment, Pharmacy/PRC budget estimate
and to determine drug handling requirements. Study drugs will be handled (defined as
receipt, storage, preparation, dispensing, and destruction) by the pharmacy/PRC or PRC-
approved delegate. At its discretion PRC may delegate study drug handling activities to

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the investigator if both the study and investigator meet specific PRC delegation criteria
and sponsor approval. Such delegation will be confirmed in writing and stipulate the
conditions under which the delegation is being awarded. Delegated studies require PRC
involvement prior to subject enrollment and may be audited for compliance with study
drug distribution procedures and institutional policy throughout the study.
2. The institution's and/or the investigators’ study drug-use control system must contain the
following elements:
a. Study drugs must be properly stored and adequately secured.
b. Study drugs will be properly packaged in accordance with all applicable
standards and regulations.
c. Study drugs will be properly labeled according to all applicable standards and
regulations so as to ensure their safe use by health care professionals and the
patient. Proper labeling includes the requirements that investigational drugs bear
the "Investigational Use Only" statement AND, if drug is leaving the UWHC
premises, the label should also indicate the institution's name, doctor's name, and
an appropriate phone number.
d. There must be a mechanism to ensure that sufficient supplies of the drugs are
always available for the study.
e. Blinded drug studies must incorporate a mechanism to break the blinding code
and reveal the identity of the drug to healthcare professionals in a medical
emergency.
f. Healthcare professionals called upon to administer investigational drugs shall
have access to adequate information about their pharmacologic action, adverse
effects, and other information pertinent to the safe and proper use of the drug.
Investigational drug information resources include:
i. UWHC/PRC Investigational Drug Monograph.
 Monographs will be created by the PRC in question/answer
format and contain self-assessment questions at the end of the
document to aid the reader in summarizing basic concepts.
 Monographs contain abbreviated information and are neither
intended for nor suitable for patient/subject education.
 Monographs will be stored electronically on U-Connect.
 Nursing and other health care providers can access this
information via Workspaces (Investigational Drug Monographs)
on U-Connect.
ii. In cases where an investigational drug monograph is not available
contact the Principal Investigator, Authorized Prescriber or PRC
pharmacist (available 24/7 via pager 2717). Lexicomp or other standard
drug information references may also be consulted.
g. There must be a method to ensure that research protocols have been approved by
the HS-IRB or Other Approved IRB; that only authorized practitioners prescribe
the study drug and that consent has been obtained. These methods may include:
i. Requirement that sponsors not send study drug to UWHC without HS-
IRB or Other Approved IRB approval.
ii. Documentation of IRB approval (HS-IRB or Other Approved IRB)
before drug is released by Pharmacy/PRC.
iii. Reference to HS-IRB or Other IRB Approved office for key personnel to
ensure that the drug is only prescribed by an authorized prescriber.
iv. Verification of subject consent by referring to the medical record, subject
or research coordinator/investigator.

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v. Ultimate responsibility of appropriate IRB approval, prescribing
authority and consent resides with the investigator. Investigator may be
contacted directly with questions, or PRC may be called for assistance.
h. Maintenance of study drug disposition records (receipt; amount dispensed to each
patient; wastage; and final disposition) must be maintained in accordance with
federal regulations and sponsor requirements.
i. If a UWHC research subject is to receive study drug at another institution,
suitable arrangements for its transfer must be made, including information
necessary to safely continue administration of the study drug (examples of
information may be the informed consent document or investigational drug
monograph).
j. Institutional records for drug studies should be designed so that various
descriptive reports may be generated conveniently and expeditiously.
D. Study Drug Control Requirements – Other locations not under the purview of the UWHC
Pharmacy Department’s Pharmaceutical Research Center (PRC)
1. In compliance with Good Clinical Practices, an investigator is responsible for the control
of study drugs used in a research project in accordance with federal, sponsor, and
applicable institutional policy. Where allowed/required, the investigators should assign
some or all of the investigator’s duties for investigational product(s) accountability at the
trial site to an appropriate pharmacist or another appropriate individual who is under the
supervision of the investigator.
2. The investigator's study drug-use control system must contain the following elements:
a. Study drugs must be properly stored and adequately secured.
b. Study drugs will be properly labeled according to all applicable standards and
regulations so as to ensure their safe use by health care professionals and the
patient. Proper labeling includes the requirements that investigational drugs bear
the "Investigational Use Only" statement
c. There must be a method to ensure that research protocols have been approved by
the HS-IRB or Other Approved IRB; that only authorized practitioners prescribe
the study drug and that consent has been obtained.
3. Ultimate responsibility of appropriate IRB approval, prescribing authority and consent
resides with the investigator.
4. The Investigator shall comply with all other polices applicable to that location.
VI. REFERENCES

Federal Register: 21 CFR Part 312; 312.60; 312.66
American Society of Health-System Pharmacists Guidelines for the Use of Investigational Drug in
Organized Health-Care Settings. Am J Hosp Pharm 1998;55:369-76 (These guidelines were reviewed in
2003 by the American Society of Health-System Pharmacists Council on Professional Affairs and by its
Board of Directors and found to still be appropriate)

VII. COORDINATION

Sr. Management Sponsor: SVP, Chief Operating Officer (COO)
Author: Manager of Pharmaceutical Research Center

Approval Committee: Administrative Policy and Procedure Committee




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SIGNED BY

Ronald Sliwinski
President of University of Wisconsin Hospitals and Chief of Clinical Operations


Revision Detail:

Previous revision: December 2014
Next revision: September 2018