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QRTI Newsline --- Wednesday September 8, 2010

Counting on Drug Accountability

by Rochelle L. Goodson

Drug accountability is so germane to clinical research that its performance is one of the routine tasks performed during most site visits. However, the amount of investigational product (drug, biologic, medical device) physically counted and/or the procedures conducted to assure that the amount of investigational product dispensed, used, and destroyed or returned for reconciliation, is not necessarily a standard part of the routine!

Despite the requirements intended to ensure accountability, the logistics (how and when) of drug/device accountability is not addressed in the regulations or guideline. Therefore, each sponsor of an investigational trial must specify a procedure that stands up to the potential scrutiny of the regulatory requirements during an inspection. This remains a formidable challenge as evidenced by the fact that inadequate drug/device accountability persists as one of the most common citations during audits and regulatory inspections.

The federal regulations specifically require and the ICH GCP Guideline states that both the sponsor and the investigator maintain adequate records related to investigational product as follows:

The sponsor must document the shipment, receipt, and disposition of investigational product
The investigator must maintain adequate records documenting the disposition of the investigational supply that includes the dates and amounts dispensed, the amounts used and returned by the study subject, and the amounts returned or destroyed.

For sponsors, company-specific requests for the shipping of investigational product and the associated shipping records, e.g., express mail slips, permit verification of shipping dates. In addition, signed and dated acknowledgements of receipt for shipped supplies provide the documentation needed to justify that the investigator or a designee received a shipment.

For investigators/site personnel, drug accountability tasks are required throughout a research trial. It is critical that sponsors assure that monitors routinely dedicate an appropriate amount of time and effort to assess the adequacy and accuracy of this process. Moreover, monitors should provide remedial instructions during the course of the trial, as deemed necessary.

The importance of physical counts of investigational product and verifying the documentation of their use and return, must be emphasized since safety and efficacy outcomes of a trial are directly related to patient compliance rates. The sponsor's ability to demonstrate that subjects took the study medication is the most critical proof in support of an efficacy claim.