Method and System for Verification of Source Data in Pharmaceutical Studies and Other Applications

Abstract

A method and system are described for verifying database entries against corresponding source data collected at a plurality of geographically remote field locations. The invention provides an electronic means of verifying field data in a manner that is quicker, less labor-intensive and less error-prone as compared with existing methods. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.

Description

[0001]This application claims priority from U.S. Ser. No. 60 / 926,577, filed Apr. 27, 2007, the disclosure of which hereby is incorporated herein in its entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The invention relates to how data collected in field locations, often geographically diverse, is verified as being accurate. The comparison is made between data that have been collected, processed, and stored in a centralized location, along with any corrections or updates made since the data were first recorded, against original source data in the field. These steps are needed to verify the accuracy of data in the centralized database. Data refers to any information, including measurements, recordings, verbal responses, images (such as x-rays or CT scans), laboratory data, output from analyzers, or any other source, including electronic, paper, or other means.[0004]Increasingly, clinical research is also under constraints to improve the ability to manage comple...

AI Technical Summary

Benefits of technology

[0016]The above-identified shortcomings of the prior art are remedied by the present invention, which provides an electronic means of organizing, checking and comparing data, and writing and tracking discrepancies with respect thereto, as well as maintaining a corresponding audit trail. This system, coupled with the ability to transmit data and meta-data to a centralized site immediately after they are generated, greatly reduces the interval between when data are collected and when “clean” data are available for analysis and decision making. This facilitates both the strategic aspects of conducting adaptive trials (i.e., changing study design while in progress, such as number of patients, treatment assignment, or other aspects) as well as the tactical aspects (such as assessing and managing study progress through tracking performance indicators such as meta-data, an essential part of the adaptive process). In addition, the invention replaces much of the work presently done by hand with a uniform, standardized electronic process, improving its efficiency and enabling it to be utilized equally well when applied by highly experienced managers and field monitors as by those with considerably less experience. Finally, the invention's ability to perform these tasks by electronic means markedly improves the speed and accuracy of the process of checking source data and in identifying, recording, and resolving discrepancies that do occur.

[0017]As an example of time savings in preparing for a site visit, this tool allows a full copy of the database to be downloaded and prepared within minutes—a fraction of the time currently required.

[0018]Comparison of source with recorded data is easily achieved by the invention's ability to easily navigate all pages of a CRF. For any page, data recorded on that page can be called up, along with a record of any change made since the data were first entered (i.e., the audit trail). In a preferred embodiment of the invention, these data are provided with a status indicator, where fields that are unmonitored have a blank checkbox. After data in the database, as reflected by the computer screen, is compared with the source and determined to be correct, a check is placed in the box through clicking the computer mouse on the checkbox. In addition, individual fields with queries outstanding are marked in red, for example, since source verification cannot be performed on such fields where data are still being processed. Discrepancies between source and recorded data can be identified quickly and fagged for clarification in a query that is returned to the site for resolution. The inventive system thus provides a very quick and effective means of generating and tracking queries that are in a uniform format that facilitates query management across monitors and sites. This capability makes it far easier for site personnel, since every query they receive will be in a standardized format.

Problems solved by technology

In addition, individual fields with queries outstanding are marked in red, for example, since source verification cannot be performed on such fields where data are still being processed.

Images