| Stark NJ, CRA Hanbook, 2009 Edition, Clinical Device Group Inc, Chicago, IL (2009). Comb bound, illustrated, 190 pages. ISBN 1-889160-17-2. $50 US. |
The field guide for monitoring medical device clinical trials. The handbook contains full text copies of US regulations, excerpts and checklists of European requirements, tables, charts, venn diagrams, and other stuff you need to look up when away from the office. Comb bound and compact, it's designed to fit in a briefcase. No monitor should be without one!
Contents
21 CFR Part 812—Investigational Device
Exemption Regulations (full text)
Comparison of Abbreviated and Full IDE Requirements
21 CFR Part 814.20—PMA Applications
21 CRF Part 11—Electronic Records; Electronic Signatures
Computerized Systems used in Clinical Trials
21 CFR Part 50—Protection of Human Subjects: Informed Consent (full text)
21 CFR Part 54—Financial Disclosure by Clinical Investigators (full text)
21 CFR Part 56—Institutional Review Boards (full text)
21 CFR Part 820—Quality System
Expedited Review List
FDA Guidelines for the Monitoring of Clinical Investigations
Declaration of Helsinki
ISO DIS 14155—Part 1 General Requirements (excerpts)
ISO DIS 14155—Part 2 Clinical Investigation Plans (excerpts)
Overview of the Monitoring Process
Adverse Events & Effects