Govender, Sumentheran N., Pekka Lähteenmäki; David Ingram, Stephanie Skoler, and Robin A. Maguire. "Bar coding: A new innovative way for drug dispensing and site management."

Abstract

In clinical trials, drug management is highly regulated by the regulatory authorities such as US FDA, and the sponsor conducting the clinical trial, in turn, plans, oversees, and controls the drug management from the manufacturing to the drug dispensing. The most important features of drug accountability are to guarantee that the right drug goes to the right trial subject, that no drug gets lost during the trial at the site, and that at all times there is an accurate inventory of the trial product throughout the trial. The trial site management is the responsibility of the principal investigator, and typically regulated by Good Clinical Practice guidelines. An ideal site management tool would be tailored according to the needs of the trial to save time, accurately manage drug, and give timely feed back via appropriate reports, would allow a better control of trial subject follow-up. This would minimize loss to follow-up, one of the most critical points of clinical trials.

The Population Council has developed a bar-coding system for the Carraguard^® Phase 3 clinical trial to achieve both the randomization and trial site management using sophisticated bar-code readers and a user-friendly database.

The system allows:

• Randomly allocating one or more unique machine-readable identifiers to clinical trial subjects and test products to allow fast and reliable management of clinical trials with minimal human errors due to transcription of text/numbers;

• Connecting one or more readers to one or more computers on which is provided software for storing and processing identifier information;

• Reading said identifiers by means of the readers to identify trial subjects and test products in different locations of a trial site; and

• Acting in accordance with a predetermined procedure to dispense a uniquely identified test product to a uniquely identified test subject.

The system has contributed to:

• Reduction of human errors in trial site management;

• Cost saving;

• Adherence to FDA compliance, 21 CFR part 11 in terms of use of computerized systems;

• Audit track of the product from the factory to the trial subject and returns if necessary;

• Documentation of procedures (sample collections, drug supply, scheduling); and

• Simplification of monitoring by the sponsor.

Poster Session
Monday, 24 April 2006, 12:30–1:30 pm
Tuesday, 25 April 2006, 12:30–1:30 pm

Microbicides 2006

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This page updated 3 April 2006

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