FDA clinical trials drug accountability

An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes. When drug accountability records are well designed and error-free, and appropriately reconcile from initial shipment to the site through final disposition, this statement should hold true. This article outlines the critical information needed for the study drug shipping manifest and the content of the dispensing and return and/or destruction documentation at the site. It discusses the importance of drug accountability records with respect to study data integrity and describes the role of study monitors in reviewing investigative site records and ensuring that they are complete and accurate. It also gives advice to auditors who assess drug accountability and discusses some of the findings from FDA inspections.

Investigational drug shipment
An accurate investigational drug accounting process begins with the sponsor’s shipping manifest. The regulations require control of investigational medications, and the safety reasons alone justify these restrictions. One must be able to confirm that investigational medication has not been dispensed to nonstudy subjects, and that subjects have not been exposed to doses in excess of protocol-defined regimens. Thus, all investigational medication documented as shipped to the site should reconcile with the documentation of used and unused supplies. Moreover, federal regulations restrict investigational drugs to research use. Marketing and commercialization are prohibited. Thus, chain of custody and strict accounting, as well as secure storage conditions at the site, must be in place for all investigational medications.

Poorly prepared manifests are a common finding during clinical site audits. For example, some manifests do not clearly describe shipment contents. Some studies involve complicated packaging, where medication is contained in multiple subject dispensers. A one-month supply of study drug may be packaged as a “kit, ” where the kit comprises four subject dispensers, each containing seven doses of a tablet form of a medication. In this instance, the manifest for one subject might read, “One (1) subject kit, containing four (4) dispensers, with seven (7) tablets per dispenser.” These details should be provided in the manifest even if the kits are supplied with tamper-evident seals.

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