Conducting Outpatient and Inpatient Clinical Research Using Legend or Investigational New Drugs
Research at a Fairview Health Services Inpatient or Outpatient Site
Any clinical research project performed by a University of Minnesota Principal Investigator involving the use of a legend or investigational new drug requires the involvement of the University of Minnesota Medical Center, Fairview Department of Pharmaceutical Services' Investigational Drug Service (hereafter referred to as "Fairview IDS").
- For inpatient settings, please contact the Fairview IDS to initiate this process.
- For outpatient settings, the Investigational Drug Service Registered Only (RO) form outlines the information that must be provided to Fairview IDS. 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.
For all inpatient studies at a Fairview Health Services site, Fairview IDS must serve as the coordinator and control center for all investigational drugs. Fairview IDS will assume responsibility for maintaining records of the drugs delivered to Fairview IDS, inventory of the drug, dispensing of drugs to research subjects, and the return to the sponsor or disposition of unused product. Fairview IDS will store and dispense the investigational drug as specified by the sponsor and in accordance with applicable regulatory requirements.
Administration of investigational medications must be performed in accordance with Fairview Hospital and Healthcare Services Investigational Drug Policy.
Research at Non-Fairview Health Services Inpatient Sites
For any inpatient and outpatient studies at a non-Fairview Health Services site, the study must be registered with the Fairview IDS.
- For inpatient settings:
- complete the Investigational Drug Service Registered Only (RO) Form.
- Academic Health Center strongly encourages an investigator to use the services of the pharmacy at the institution where the inpatients will be seen. If the pharmacy at the institution serving as the site for the inpatient study is not coordinating the control of the research drug, as outlined in the previous section, then the principal investigator is responsible for the control of the drug
- For outpatient settings:
- Review the Investigational Drug Drug Service Registered Only (RO) Form.which outlines the information that must be provided to Fairview IDS.
- The Academic Health Center strongly encourages an investigator to use the services of Fairview IDS as the coordinating and control center for the research drug, The Fairview IDS pharmacist may be delegated authority by the Principle Investigator to serve as the coordinating and control center for maintaining records of the drugs delivered to Fairview IDS, inventory of the drug, dispensing of drugs to research subjects, and the return to the sponsor or disposition of unused product. Fairview IDS will store and dispense the investigational drug as specified by the sponsor and in accordance with applicable regulatory requirements. If Fairview IDS is not coordinating the control of the research drug, as outlined in this paragraph, then the principal investigator is responsible for the control of the drug. However, all legend and investigational new drugs must be registered with Fairview IDS.
The following outlines the investigator's responsibilities with regards to using legend and investigational drugs in research. As reference, the following link from the Fairview IDS will provide additional details: Investigator Dispensing and Study Drug Management Requirements.
A. Maintaining a 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(s).
B. Storing Investigational Drugs
The Investigator must ensure that the investigational product(s) are 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).
C. Dispensing Drugs
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 their 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.
D. Labeling Drugs
The Code of Federal Regulations specifies the following labeling requirements for an investigational new drug:
- The immediate package of an investigational new drug intended for human use must bear a label with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use."
- The label or labeling of an investigational new drug must not bear any statement that is false or misleading in any particular and must 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 to self-administer, unless dispensed in unit dose, must be labeled with specific information: name, address, and telephone number of clinic or physician's office.
- prescribing physician's name
- patient's name
- date of dispensing
- "prescription" number – may be a visit number with a date. Has to be unique to the patient and the patient's visit
- directions for use
- drug name/study name/protocol name or number
- name of manufacturer or distributor of finished dosage form (if this information is contained on the sponsor’s label it does not have to be included on the label affixed by the dispenser)
- any auxiliary labels – i.e. Caution: new drug – limited by federal law to investigational use
E. Drug Administration
Legend and investigational new drugs must 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 must 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.