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

a source data and system technology, applied in the field of method and system for source data verification in pharmaceutical studies and other applications, to achieve the effect of improving the speed and accuracy of the process of checking, reducing the interval, and improving the efficiency of the process

Inactive Publication Date: 2008-10-30
ROSENBERG MICHAEL J
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  • Abstract
  • Description
  • Claims
  • Application Information

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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 oth

Problems solved by technology

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

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Embodiment Construction

[0036]Clinical trials are generally highly complex processes that involve collection of many thousands of data elements from multiple clinical sites, laboratory facilities, regulatory agencies, and often outside vendors such as companies supplying test drugs. Many of the foregoing may be in different countries, which present the challenges of different cultures, languages, time zones, and other differences that complicate the ability to effectively manage such diverse participants in a clinical evaluation. The quality of the data collected in such circumstances is of paramount importance, because accurate data are necessary to demonstrate the efficacy and safety of any pharmaceutical product being evaluated. Failure to optimize data quality slows study progress; requires a greater number of patients in order to demonstrate an effect; impairs the ability of a manager to change a study based on what already has occurred in the course of the study; and slows regulatory filings because ...

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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...

Claims

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Application Information

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IPC IPC(8): G06F17/30G06F7/04G16H10/20G16H40/20
CPCG06F17/30303G06F16/2365G06F16/215G06F16/245G06F16/252G06F16/24578G16H40/20G16H10/20G16H70/60
Inventor ROSENBERG, MICHAEL J.
Owner ROSENBERG MICHAEL J
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