CRA Handbook 2008 Electronic Edition

The Electronic version of the CRA Handbook has been formatted for easy on-screen viewing and designed specifically for loading onto your laptop. There is extra space in the margins so you can make screen notes with Adobe Writer. The handbook is indexed for faster searching and is bookmarked for ready location of information.

Contents


 
Stark NJ, ed.CRA Handbook 2008 Electronic Edition, Clinical Device Group Inc, Chicago, IL. eBook on CD,  $45 US.

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
90/385/EEC—Active Implantable Medical Device Directive (excerpts)
93/42/EEC—Medical Device Directive (excerpts)
Declaration of Helsinki
prEN/ISO DIS 14155—Part 1 General Requirements (excerpts)
prEN/ISO DIS 14155—Part 2 Clinical Investigation Plans (excerpts)
Overview of the Monitoring Process
Adverse Events & Effects