CLINICAL TRIAL EDC TASK GROUP OF PHRMA BIOSTATISTICS & DATA MANAGEMENT TECHNICAL GROUP
POSITION PAPER
EDC Position Paper Revision 1, May 1, 2005
1
Electronic Clinical Data Capture
Position Paper Revision 1
May 1, 2005
Clinical Trial Electronic Data Capture
Task Group
PhRMA Biostatistics and Data Management
Technical Group
CLINICAL TRIAL EDC TASK GROUP OF PHRMA BIOSTATISTICS & DATA MANAGEMENT TECHNICAL GROUP
POSITION PAPER
EDC Position Paper Revision 1, May 1, 2005
2
Table of Contents
1. BACKGROUND .....................................................................................................................................5
2. PURPOSE.................................................................................................................................................5
3. NOTES FOR REVIEWING THIS PAPER .......................................................................................6
4. AUDIENCE..............................................................................................................................................7
5. REFERENCES........................................................................................................................................7
6. ROLES AND RESPONSIBILITIES ...................................................................................................7
7. DEFINITIONS AND ACRONYMS ....................................................................................................9
7.1.
ELECTRONIC DATA CAPTURE (EDC) ...............................................................................................9
7.2.
SOURCE DATA ...................................................................................................................................9
7.3.
ELECTRONIC CASE REPORT FORM DATA .......................................................................................10
7.4.
E-CRF .......................................................................................