Available in Spiral or Perfect Binding!
The 2010 CFR/ICH GCP Reference Guide contains:
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FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 312, & 314. Plus, a new section on Expanded Access Drugs. Including, new Section 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use
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Good Laboratory Practice Part 58
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ICH Guidelines Good Clinical Practice (E6) and Clinical Safety Data Management (E2A)
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The European Union Clinical Trials Directive and The European Union Good Clinical Practice Directive
The convenient and easy-to-reference pocket guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, site and management organizations, CRAs, sponsors, investigator meetings, research facilities, universities, hospitals, and more!
The CFR/ICH Reference Guide provides the critical information you need to know to stay current with the industry’s codes and regulations.
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4"x7" spiral bound soft cover pocket guide.
Spiral binding also available.
Device-Specific CFR Guide also available.