Overview
The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. If the investigator is also serving as the sponsor, additional regulations must also be taken into consideration as part of the oversight process.
Being accountable for the IP includes, but is not limited to, documenting the conditions under which the test article was shipped, stored, administered, returned, and/or destroyed, along with any special labeling or quality control measures that may be required. The research team must also be trained on proper administration of the IP as well as any protocol related requirements for its safe and appropriate use such as randomization and un-blinding procedures.
Because of the variety of products that are regulated and the additional responsibilities assumed by sponsor investigators, it is imperative that a thorough review of relevant federal, state, and local regulations is routinely performed to protect the safety of research subjects and meet study specific regulatory obligations.
Investigational Drugs
Research teams at the University of Michigan Medical School are required to use the U-M Research Pharmacy (please see the IRB guidance on exceptions to this) when providing investigational drugs for a clinical trial. The U-M Research Pharmacy team members follow well-established standards for temperature monitoring, dispensation, storage, etc. It is highly recommended that all investigational drugs be sent directly to the Research Pharmacy for storage and distribution.
If the research team has obtained a waiver from the U-M Institutional Review Board Medical School (IRBMED) granting permission not to use the U-M Research Pharmacy, the research team must provide procedures and/or guidelines to describe the processes that will be used for handling and dispensing the investigational drug.
Investigational Devices
Accountability for medical devices is generally not managed through the Research Pharmacy. Under most circumstances, clinical trial research teams will be responsible for documenting the processes associated with handling and dispensing investigational devices. However, the Research Pharmacy may provide IP accountability for combination products consisting of an investigational device and an investigational drug.
Investigational devices may need to undergo additional quality control measures to ensure they are safe, and may need to be registered with the University. Consult with local regulatory (MIAP, IRBMED) and clinical engineering (Clinical Engineering Unit) authorities for additional information and guidance.
It is important to note that investigational devices (even if FDA cleared or approved) must be kept separate from other devices that are not being used on the clinical trial, in a secure and locked area.
Combination Products
Please note the U-M Research Pharmacy will also handle some combination products (device with drug included in the device) for accountability purposes.
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Questions?
Contact us at MICHR-SPGSupport@umich.edu.