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.