The 2015 CFR/ICH GCP Reference Guide contains:
- Updated as of April 1, 2015! FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 312, & 314
- ICH Guidelines Good Clinical Practice (E6) and Clinical Safety Data Management (E2A)
- The European Union Clinical Trials Directive and The European Union Good Clinical Practice Directive
Updates to this year’s CFRs reflect the new rules regarding postmarketing reporting of adverse drug experiences, including definitions, review, reporting, specific rules for postmarketing studies, patient privacy, and recordkeeping.
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.