Authorized University employees must comply with federal and state regulations and University of Minnesota 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 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. The Office for Regulatory Affairs, within Research Integrity and Oversight Programs, 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.
Exclusions
This policy does not apply to legend drugs dispensed by a practitioner to a patient for treatment purposes only, as authorized by his/her license.
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.
- 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
industry. The FDA is responsible for ensuring that the drugs 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.
- 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.
- Office for Regulatory Affairs
- The Clinical Research Compliance Program will monitor compliance during
each randomly selected research study review. Any corrective action may be
facilitated through the Compliance Coordinator, or required by the University
of Minnesota Medical Center, Fairview Investigational Drug Service or University
of Minnesota Vice President for Research through the Office for Regulatory
Affairs and Department of Environmental Health and Safety.
There is no FAQ for this policy.
- Amended:
- May 2009 - Combined procedures into one to streamline information, added new form: Investigational Drug Studies Registration form.
- Effective:
- November 1999
-
To obtain a copy of a historical policy,
e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.
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