Conducting Outpatient Clinical Research Using Legend or Investigational Drugs

• Fairview Health Services Outpatient Sites
• Non-Fairview Health Services Outpatient Sites
• The Principal Investigator's Specific Responsibilities

Any clinical research project performed by a University of Minnesota Principal Investigator involving the use of a legend or investigational new drug for research in an outpatient setting will require that the study be registered with the Department of Pharmaceutical Services. The Outpatient Registration of Investigational Drug Studies form outlines the information that must be provided to the FUMC Investigational Drug Service. The dispensing and administration of the drug must be in accordance with all Federal and State Regulations, as well as Fairview Hospital and Healthcare Services Investigational Drug Policy.

Non-Fairview Health Services Outpatient Sites

Any clinical research project performed by a University of Minnesota Principal Investigator involving the use of a legend or investigational new drug for research in an outpatient setting at a non-Fairview Health Services site must be registered with the FUMC Department of Pharmaceutical Services' Investigational Drug Service. The Outpatient Registration of Investigational Drug Studies form outlines the information that must be provided to the Investigational Drug Service.

The Academic Health Center strongly encourages an investigator to use the services of the FUMC Investigational Drug Service as the coordinating and control center for the research drug. As the coordinating and control center, the FUMC Investigational Drug Service assumes the responsibility for maintaining records of the drugs delivered to the FUMC Investigational Drug Service, inventory of the drug, dispensing of drugs to research subjects, and the return to the sponsor or disposition of unused product. The FUMC Investigational Drug Service will store and dispense the investigational drug as specified by the sponsor and in accordance with applicable regulatory requirements.

If the FUMC Investigational Drug Service is not coordinating the control of the research drug, as outlined in the above paragraph, then the principal investigator is responsible for the control of the drug.

The principal investigator's specific responsibilities in controlling the drug are:

Drug Accountability Record

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. These records should include dates, quantities, batch/serial numbers, expiration dates, and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

In regard to the "use by each subject", investigators should maintain drug accountability records that document adequately which subject(s) received the drug; when the subject(s) received the drug; and the specific dosage the subject(s) received. A written physician's order to administer the drug and the medication administration record must be present in the subject(s)' chart.

Drug Storage

Investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s). Storage guidelines, include:

• Storage area is large enough for the supply of study drug.
• Storage area can be locked.
• Investigational drug is stored separately from other compounds.
• Non-dispensed drug is stored separately from returned dispensed drug.
• Inventory control procedures are used.
• Any environmental controls are maintained.
• Access is limited to study staff.
• Controlled substances are stored in a locked location (Please refer to Policy 2.1.4, Using Controlled Substances for Research).

Drug Dispensing

According to the Minnesota Statutes and Rules, only a licensed practitioner or pharmacist is authorized to compound or dispense legend drugs. This applies to legend drugs used in a research project and to those drugs not yet approved by the Food and Drug Administration. A practitioner is defined as a licensed: doctor of medicine, doctor of osteopathy (duly licensed to practice medicine), doctor of dentistry, doctor of optometry, podiatrist, or veterinarian. A physician assistant and advanced practice registered nurses (i.e., certified nurse midwives, certified registered nurse anesthetists, certified nurse practitioners, and certified clinical nurse specialists) are authorized to prescribe, dispense, and administer drugs within his/her scope of practice. A physician assistant or advanced practice registered nurse must have a written agreement with a physician defining the scope of the delegated responsibilities related to the prescription, dispensing and administration of drugs.

Drug Labeling

The Code of Federal Regulations specify the following labeling requirements for an investigational new drug:

1. The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use."
2. The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.

The Minnesota Rules state that all drugs dispensed to or for a patient, unless dispensed in unit dose, must be labeled with the following:

1. name, address, and telephone number of clinic dispensing;
2. patient's name or identifying number;
3. prescription number, or way of tracking the dispensing;
4. name of prescribing physician;
5. directions for use;
6. name of manufacturer of the finished dosage form;
7. auxiliary labels as needed (e.g., "Take on empty stomach");
8. date of original issue or renewal; and
9. generic or trade name of drug and strength, or study name to identify drug, except when specified by prescriber to the contrary. In the case of combining premanufactured drug products, the manufactured drug products, the names of the products, or a category of use name shall suffice. In the case of compounding basic pharmaceutical ingredients, the common pharmaceutical name (if such exists), the names and strengths of the principal active ingredients or a category of use shall suffice (Minnesota Rule 6800.3400 and 6800.9953).

Drug Administration

Legend and Investigational New Drugs shall be administered in accordance with any applicable State or Federal Regulations and in accordance with any policies or procedures set forth by the University of Minnesota Institutional Review Board. An informed consent form, signed and dated by the subject; and a physician's order to administer the drug must be present before administering the drug to the subject.

Only a person licensed within the state of Minnesota and so authorized by their professional scope of practice shall administer a legend or investigational new drug to a subject. A principal investigator may designate the responsibility of administering the drug only after the designee has been given and has demonstrated an understanding of basic pharmacologic information about the drug. This education and delegation of responsibility must be documented. Investigational drugs are to be administered in accordance with research protocol and in accordance with any other hospital or clinic policy pertaining to the administration of medications.