The 2012 CFR/ICH GCP Reference Guide contains:
Updated as of April 1, 2012! 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.
New in 2012! Regulations regarding notifications of drug shortages and/or manufacturing changes that could lead to drug shortages.
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.
Perfect binding also available.
Device-Specific CFR Guide also available.