Investigational Product (IP) Management-Study Execution
An investigational product (IP) can be a drug, a biologic, or a device. Investigational product management during study execution 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. The research team must adhere to applicable IP handling manuals, Investigator’s Brochures and protocol related requirements for the safe and appropriate use of the IP. In addition, the Sponsor and Investigators must maintain the records required by Good Clinical Practices (GCP).
It is the responsibility of the site Principal Investigator of a clinical trial to ensure the accurate and complete accountability including the proper storage and disposition of investigational products during the lifecycle of the research. This PowerPoint slide deck Penn Medicine One Research Site IP Management Study Start Up educates site investigators and staff on the required elements of IP accountability management during the study execution phase of a trial.
During the study/investigation, the (regulatory) sponsor is responsible for ensuring that vendors used for the investigational product (manufacturer, pharmacy, etc.) maintain adequate resources and qualifications to continue to serve as a qualified vendor. This should be done in accordance with GCP and PSOM SOP 002.
The (regulatory) sponsor should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s) in the trial master file. These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Sponsors should obtain from the investigator the records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product.
As additional information about the product is learned or as changes to the product are made, appropriate updates to the product handling manuals, investigator’s brochures, updated protocols and other applicable documents should be made. The sponsor should keep the site teams informed of emergent safety concerns as required by Federal regulations.
For additional details, refer to PSOM SOP 003 – Investigational Product Management.