Printed on: 08/19/2018. Please go to http://policy.umn.edu for the most current version of the Policy or related document.

ADMINISTRATIVE POLICY

Using Legend and Investigational Drugs for Clinical Research

Responsible University Officer(s):

  • Vice President for Research

Policy Owner(s):

  • Associate Vice President for Research

Policy contact(s):

Date Revised:

Nov 7, 2013

Effective Date:

Nov 1, 1999

POLICY STATEMENT

Authorized University employees must comply with federal and state regulations and University policies and procedures when conducting research with legend drugs and investigational drugs. The use of these drugs in research includes requirements for labeling, storage, dispensing, inventory maintenance, and substance disposal. For example:

  • The investigator must maintain records of the product's delivery to the study site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product.
  • Authorized personnel should store investigational product(s) as specified by the sponsor and in accordance with applicable regulatory requirement(s).
  • Only a licensed practitioner or pharmacist is authorized to compound or dispense legend drugs.

Any clinical research project performed by an investigator involving the use of a legend or investigational new drug in an inpatient setting will require involvement of the University of Minnesota Medical Center, Fairview Department of Pharmaceutical Services' Investigational Drug Service (hereafter referred to as "Fairview IDS"). For all inpatient studies at a Fairview Health Services site, Fairview IDS serves as the coordinator and control center for all investigational drugs. For all outpatient studies at a Fairview Health Services site, the Investigational Drug Studies Registration form outlines the information that must be provided to Fairview IDS. For any studies at a non-Fairview Health Services site, the study must be registered with Fairview IDS.

Fairview IDS has the right to audit the processes in place to monitor and control the use of investigational drugs and to require corrective action. Research Compliance Office (RCO) in the Office of the Vice President for Research is also responsible for monitoring compliance.

Failure to comply with this policy may be grounds for discipline by the University, suspension or termination of research by the University Institutional Review Board, referral for academic misconduct proceedings and/or reporting to external licensing authorities. Any disciplinary action taken by the University will follow the employment rules governing the individual's employment category.

This policy does not apply to legend drugs dispensed by a practitioner to a patient for treatment purposes only, as authorized by the practioner's license.

REASON FOR POLICY

This policy is intended to promote the safe handling of drugs used in clinical research, reinforce the protections afforded human subjects who are administered drugs under research protocols, help detect and prevent diversion of drugs for unauthorized purposes, and assure compliance with applicable laws and internal requirements related to the use of legend and investigational drugs for research purposes.

PROCEDURES

FORMS/INSTRUCTIONS

APPENDICES

FREQUENTLY ASKED QUESTIONS

CONTACTS

Subject
Contact
Phone
Fax/Email
Primary Contact(s)
612-625-2046
Advising, Consulting, Notification, and General Questions Regarding Policy
Investigational Drug Service
612-273-6212
612-273-2176

DEFINITIONS

Administer
To deliver by, or pursuant to the lawful order of a practitioner, a single dose of drug to a patient or research subject by injection, inhalation, ingestion, or by any other immediate means.
Authorized Personnel
The University of Minnesota Medical Center, Fairview Investigational Drug Service, a principal investigator and an employee supervised by the principal investigator. There must be documentation outlining the delegation of responsibility(ies) to the employee by the principal investigator; and dispensing and administration may only be delegated to employees licensed and authorized in the state of Minnesota to perform the task being delegated.
Dispensing
The preparation or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the drug.
Employees/Members of the University
Faculty, staff and any other individuals employed by the University, using University resources or facilities, or receiving funds administered by the University, and volunteers and representatives who may speak or act as agents for the University. Members do not include students taking courses, attending classes, or enrolled in an academic program unless they meet one of the other criteria.
Food and Drug Administration
The regulatory authority in the United States which oversees the pharmaceutical and medical device industries. The FDA is responsible for ensuring that the drugs and medical devices marketed in the US have a greater benefit than risk when used according to manufacturer's directions.
University of Minnesota Medical Center, Fairview Investigational Drug Service
A division of Fairview Hospital and Health Care Systems' Department of Pharmaceutical Services. It is located in the Fairview-University Medical Center complex. (Referred to in the policy and procedure at "Fairview IDS").
Investigational New Drug
A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.
Legend Drug
A drug which is required by federal law to bear the following statement, "Caution: Federal law prohibits dispensing without prescription."
Licensed Practitioner
A licensed doctor of medicine; doctor of osteopathy duly licensed to practice medicine; licensed doctor of dentistry; licensed doctor of optometry; licensed podiatrist; licensed veterinarian; and physician assistant or advanced practice nurse authorized to prescribe, dispense, and administer drugs under chapters 147A and 148.235, respectively.
Minnesota Board of Pharmacy (MNBP)
The agency authorized by Minnesota statue to regulate drugs.
Licensed Pharmacist
An individual with a currently valid license issued by the Minnesota Board of Pharmacy to practice pharmacy.
Registration
All outpatient investigational drug studies must be registered with The Department of Pharmaceutical Service, as described in the Outpatient Registration of Investigational Drug Studies form.

RESPONSIBILITIES

Authorized Personnel
Properly receive, store, dispense, administer and dispose of drugs used in clinical research, according to federal and state regulations and University of Minnesota Policies and Procedures. The University of Minnesota Medical Center, Fairview IDS may be contracted to perform this responsibility for the investigator.
University of Minnesota Medical Center, Fairview Investigational Drug Service
Maintain a current list of all inpatient studies and outpatient studies using legend and investigational new drugs in research. Serve as the coordinator and control center for all investigational drugs as defined in the Inpatient and Outpatient Clinical Research Studies Using Legend or Investigational New Drugs Procedures. The Department of Pharmaceutical Services also has the right to audit the processes in place to monitor and control the use of investigational drugs and to require corrective action.
Principal Investigator
Control of drug(s) under investigation. This includes ensuring that the receipt, storage, dispensing, administration, return, and disposal of the drug is performed and documented according to state and federal regulations. The investigator is also responsible for ensuring that the subject is eligible to receive the drug under investigation.
Human Research Protection Program (HRPP)
The HRPP Compliance Specialists will monitor compliance during each randomly selected research study review. Any corrective action may be facilitated through these specialists, or required by the University of Minnesota Medical Center, Fairview Investigational Drug Service or University of Minnesota Vice President for Research through HRPP and Department of Environmental Health and Safety.

RELATED INFORMATION

HISTORY

Amended:
November 2013 - Comprehensive Review, minor revision. Updated contact information, clarified roles and responsibilities.
Amended:
May 2009 - Combined procedures into one to streamline information, added new form: Investigational Drug Studies Registration form.
Effective:
November 1999
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