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Resources
Clinical Studies
Guideline for the Monitoring of Clinical Investigations
Quality in FDA-Regulated Clinical Research
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
International Conference on Harmonization (ICH) E6-Guideline for Good Clinical Practice
Guidance for Industry-Computerized Systems Used in Clinical Trials
Statistical Principles for Clinical Trials-ICH-E9; Consensus Guidelines
Guideline for the Monitoring of Clinical Investigations
Clinical Trial Forms
Medical Device
FDA-Center for Devices and Radiological Health (CDRH)
Medical Device User Fee and Modernization Act (MDUFMA) of 2002
Device Advice
CFR Title 21
Office of Regulatory Affairs-Inspection References
Guidance for Industry-Part 11, Electronic Records; Electronic Signatures-Scope and Application
General Principles of Software Validation; Final Guidance for Industry
Educational
Virtual anesthesia textbook provides updated information on anesthesiology
Surgical Principles Course materials--University of Pennsylvania
MEDLINE
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