Clinical Research Using Drugs
- Associate Vice President for Research
- Director - Research Compliance Office
- Sarah Waldemar
Employees and other members of the University must comply with federal and state regulations and University policies and procedures when conducting research with either legend or investigational drugs or medications or substances regulated by the Food and Drug Administration (FDA) but available without prescription (see HRP-306) Drugs and Biologics Worksheet and footnotes [HRP-306]). The use of drugs in research includes requirements for procuring, dispensing, labeling, storage, inventory maintenance, administering, and substance disposal. These requirements are specifically outlined under the Procedures. The principal investigator for a clinical research study using drugs holds primary responsibility for ensuring compliance. Failure to do so results in an elevated level of risk for study participants, their families, study personnel, and the institution as a whole.
Investigators using drugs or conducting clinical research studies requiring administration of drugs must either contact Fairview Investigational Drug Services (Fairview IDS) for full services or enroll in a “Registered Only” status using the IDS Registration Only (RO) Form. Researchers who select the RO process bear full responsibility for ensuring the safe storage of their drugs. All projects must also be entered into the Clinical Trials Management OnCore System. Investigators are responsible for providing Fairview IDS access to the study OnCore record to allow them to enter the Fairview IDS identification number, regardless of whether the full service or RO option is chosen. Fairview Research Administration is responsible for providing researchers with the Fairview IDS identification number as part of their ancillary review and approval correspondence. Investigators are responsible for entering the Fairview IDS identification number into the appropriate study protocol in ETHOS. The IRB will not finalize approval of a protocol until after receipt of the Fairview Research Administration approval correspondence to the researcher which will include the Fairview IDS identification number.
All projects which recruit and enroll participants affiliated with Fairview Health Services for inclusion as either an in-patient or an out-patient must use Fairview IDS for drug management. RO status is not an option for these participants. For any studies at a non-Fairview Health Services site, the study must, at a minimum have RO status with Fairview IDS and be entered into OnCore.
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. As part of its charge, the Research Compliance Office (RCO) in the Office of the Vice President for Research is responsible for developing and implementing a process for monitoring compliance with this policy, including oversight of the Fairview IDS processes.
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.
Reason for Policy
This policy is intended to promote the safe handling of drugs used in clinical research, reinforce the protections afforded human participants 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 drugs in clinical investigations.
|Primary Contact(s)||Sarah Waldemarfirstname.lastname@example.org|
|Advising, Consulting, Notification, and General Questions Regarding Policy||Fairview Investigational Drug Serviceemail@example.com
- To deliver, pursuant to the lawful order of a practitioner, a single dose of drug to a patient or research subject by injection, inhalation, ingestion, or 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 an employee(s) by the principal investigator; and dispensing and administration may only be delegated to a practitioner licensed in the state of Minnesota to perform the task being delegated.
- Clinical Investigation
- Any experiment in which a drug is administered, dispensed, or used involving one or more human participants. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
- 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.
- Fairview Investigational Drug Service (Fairview IDS)
- The Investigational Drug Service provides many useful services that aid investigators with setting up, organizing, and running their studies. The Investigational Drug Pharmacist will review the protocol, and discuss with the Principal Investigator (or designee) ways to assure that all aspects of the pharmacy part of the study run smoothly. The Investigational Drug Service provides patients, staff, investigators, and sponsors with a well organized and properly run study that will meet all state and federal rules and regulations..
- Fairview Research Administration
- A division of Fairview Hospital and Health Care Systems responsible for ancillary review of research studies involving Fairview resources.
- Food and Drug Administration (FDA)
- 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.
- Human Research Protection Program (HRPP)
- The program's most basic function is to develop and implement policies and practices that ensure the adequate protection of research participants. The group within the HRPP that carries out each function may vary according to the specifics of the research protocol:
- comprehensive review of protocols
- ethically sound participant-investigator interactions
- ongoing (and risk-appropriate) safety monitoring
- quality improvement (QI) and compliance activities
- Institutional Review Board (IRB)
- The Institutional Review Board (IRB) reviews research projects involving human participants, working with investigators to ensure adequate protection and informed, uncoerced consent and is a key component of the University’s Human Research Protection Program.
- Investigational New Drug
- A new drug, antibiotic drug, or biological drug not yet cleared for marketing that is used in a clinical investigation as outlined in HRP-306. The term also includes a biological product used in vitro for diagnostic purposes. The terms “investigational drug” and “investigation new drug” are deemed to be synonymous for purposes of this policy.
- Legend Drug
- Legend drug means drugs that are approved by the U.S. Food and Drug Administration (FDA) and that are required by federal or state law to be dispensed to the public only on prescription of a licensed physician or other licensed provider. In the U.S., a legend drug can be a controlled substance (narcotic), or a non-narcotic drug authorized by veterinarians, dentists, optometrists, and medical practitioners. Basic-level registered nurses, medical assistants, clinical nurse specialists, nurse anesthetists, nurse midwives, emergency medical technicians, psychologists, and social workers do not have the authority to prescribe legend drugs. Legend drug is also called a prescription drug.
- Licensed Pharmacist
- An individual with a currently valid license issued by the Minnesota Board of Pharmacy to practice pharmacy.
- 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; or 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 statute to regulate drugs.
- Fairview Investigational Drug Service (Fairview IDS)
- Maintain a current list of all studies using drugs in research, both those using for full services or those with a Registered Only (RO) status. Serve as the coordinator and control center for all drugs used for research as defined in this policy’s procedures and as outlined in HRP-306. 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. Fairview IDS responsibilities do not include oversight of studies with RO status.
- Fairview Research Administration Department
- Responsible for Ancillary Review of all studies involving Fairview resources, including drugs and biologicals as outlined in HRP-306. Fairview Research Administration will include the assigned IDS registration number in communications to the investigator whose responsibility it is to enter this number in their ETHOS protocol.
- Human Research Protection Program (HRPP) Quality Assurance
- The Quality Assurance (QA) program evaluates investigator and Institutional Review Board (IRB) compliance with organizational policies, procedures, and applicable laws and regulations for human research activities conducted or overseen by the University of Minnesota.
- Institutional Review Board (IRB)
- Ensures that prior to commencing study recruitment, researchers have either committed to use Fairview IDS or completed the RO form and received an IDS identification number from Fairview IDS. IRB will stipulate that approval is not complete until the IDS registration number has been received via the communication to the PI regarding approval by the Fairview Ancillary Review.
- Principal Investigator
- Ensures that the procurement, dispensing, secure storage, inventory maintenance, 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 participant is eligible to receive the drug under investigation. The investigator may opt for use of Fairview IDS services or the Registered Only (RO) option. Regardless, the investigator must provide access to the study OnCore record so that IDS can enter the appropriate identification number. Investigators are also responsible for entering the IDS number in the appropriate ETHOS protocol once Fairview Ancillary Review approval has been received.
- All investigational drug studies must, at a minimum, be registered with Fairview IDS and within the OnCore study record. The two options available are to (1) elect to have Fairview IDS to manage the investigation product or (2) choose the RO option which requires researchers to fully manage dispensing, labeling, secure storage, inventory maintenance, and disposal of drugs as described in this policy’s procedures.
- Research Compliance Office (RCO)
- Responsible for oversight of the policy processes and fulfillment of roles and responsibilities related to the use of drugs in clinical research. In cases of noncompliance corrective action may be required by the IRB, Fairview IDS, the Office of the Vice President for Research, or the Office of Academic Clinical Affairs.
- Board of Regents Policy: Research Involving Human Participants (PDF)
- Administrative Policy: Using Controlled Substances for Research
- Administrative Policy: Drug Free University
- Fairview Investigational Drug Policy
- Investigational New Drug Application (21 CFR 312, subparts A-F)
- Minnesota Statutes (Pharmacy, Chapter 151)
- Minnesota Rules (Minnesota Board of Pharmacy, Chapter 6800)
- May 2019 - Comprehensive Review. Title change, procedure revisions and clarifications
- November 2013 - Comprehensive Review, minor revision. Updated contact information, clarified roles and responsibilities.
- May 2009 - Combined procedures into one to streamline information, added new form: Investigational Drug Studies Registration form.
- November 1999