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Guidance for Industry Computerized Systems Used in Clinical Investigations -
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이매스 -
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Guidance for Industry Computerized Systems Used in Clinical Investigations
U.S. Department of Health and Human Services
Food and Drug Administration (FDA)
Office of the Commissioner (OC)
May 2007
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND............................................................................................................... 2
III. SCOPE ............................................................................................................................... 3
IV. RECOMMENDATIONS.................................................................................................. 3
A. Study Protocols ..............................................................................................................................3
B. Standard Operating Procedures...................................................................................................3
C. Source Documentation and Retention..........................................................................................4
D. Internal Security Safeguards ........................................................................................................4
1. Limited Access ................................................................................................................................4
2. Audit Trails .....................................................................................................................................4
3. Date/Time Stamps ............................................................................................................................5
E. External Security Safeguards .......................................................................................................5
F. Other System Features ..................................................................................................................6
1. Direct Entry of Data ........................................................................................................................6
2. Retrieving Data...............................................................................................................................6
3. Dependability System Documentation ............................................................................................. 6
4. System Controls ...............................................................................................................................6
5. Change Controls ..............................................................................................................................7
G. Training of Personnel ....................................................................................................................7
DEFINITIONS............................................................................................................................. 8
REFERENCES............................................................................................................................. 9
APPENDIX A.............................................................................................................................. 10
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