New in 2011! The all-new section 312.32 IND Safety Reports (Sponsor Requirements) and amended section 312.64 (Investigator Requirements) which took effect March 28, 2011.
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
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.
Title 21, Part 11 – Electronic Records; Electronic Signatures
Title 21, Part 50 – Protection of Human Subjects
Title 21, Part 54 – Financial Disclosure by Clinical Investigators
Title 21, Part 56 – Institutional Review Boards
Title 21, Part 58 – Good Laboratory Practices for NonClinical Laboratory Studies
Title 21, Part 312 – Investigational New Drug Application
Title 21, Part 314 – Applications for FDA Approval to Market a New Drug
E6 – Good Clinical Practices
E2A – Clinical Safety Data Management
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive