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Clinical Trials Information
Clinical Informatics
Computerized Systems Used In Clinical Trials
- [FDA web site]
21 CRF Part 11 - Electronic Signature and Record (ERES)
- [FDA web site]
21 CFR Part 820 - Quality System Requirements (QSRs)
- [FDA web site]
General Principles of Software Validation
- [FDA web site]
ICH E9 "Statistical Principles for Clinical Trials"
- [FDA web site]
ICH E2B "Data Elements for Transmission of Individual Case Safety Reports"
[pdf]
- [FDA web site]
ICH E2C Periodic Safety Update Reports for Marketed Drugs"
- [FDA web site]
ICH E3 "Structure and Content of Clinical Study Reports"
[pdf]
- [FDA web site]
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The National Institute on Drug Abuse (NIDA) is part of the
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Last updated on Tuesday, February 1, 2005
.