Clinical Data Collection And Management

Mazen Abdellatif

DISCLAIMER

The opinions expressed in this chapter are solely those of the author and do not necessarily reflect those of the Department of Veterans Affairs (DVA), the VA Cooperative Studies Program (VACSP), or the Hines VA Cooperative Studies Program Coordinating Center (CSPCC).

Contents

25.1 Introduction

25.2 Data Collection Versus Data Management

25.2.1 Data Collection

25.2.2 Data Management

25.2.3 Integration

25.3 Communication

25.3.1 Direct Contact Meetings

25.3.2 Mail Carrier

25.3.3 Telephone

25.3.4 Fax

25.3.6 Web Sites

25.3.7 File Transfer Protocol

25.3.8 Videoconferencing

Computer Applications in Pharmaceutical Research and Development, Edited by Sean Ekins. ISBN 0-471-73779-8 Copyright © 2006 John Wiley & Sons, Inc.

25.4 Pure Paper-Based Systems

25.4.1 Suitability and Hardware/Software Requirements

25.4.2 Design and Implementation

25.4.3 Managing Data

25.5 Electronic-Based Systems

25.5.1 Centralized Systems

25.5.2 Distributed Systems

25.5.3 Wireless Systems

25.5.4 PDF-Based Systems

25.5.5 Web-Based Systems

25.5.6 Direct Systems

25.6 Hybrid Systems

25.6.1 Paper Data Collection with Centralized Interactive Data Entry

25.6.2 Paper Data Collection with Centralized Batch Data Entry

25.6.3 Paper Data Collection with Direct Data Transfer to Centralized DMS

25.6.4 Integration of Distributed Systems with Remote Servers over the Internet

25.7 Acquiring Proprietary e-Clinical Software

25.7.1 The New Trend

25.7.2 e-Clinical Software Examples

25.7.3 Questions to Ask the Vendors

25.8 Processes Before Data Collection

25.8.1 Choosing a Data Collection and Management System

25.8.2 Hardware and Software Selection

25.8.3 Form and System Design

25.8.4 Protocol and System Rules

25.8.5 System Development

25.8.6 System Validation

25.8.7 Staff Training

25.9 Processes During Data Collection

25.9.1 System Evaluation

25.9.2 Subject Management

25.9.3 Data Quality Assurance

25.9.4 Treatment Dispensing

25.9.5 Handling Unexpected Events

25.9.6 Data Transformation

25.10 Processes After Data Collection

25.10.1 Data Lockout

25.10.2 Data Retention

25.10.3 Data Archiving

25.10.4 Data Sharing

25.11 Final Comments Acknowledgments References

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