CRA Handbook 2009 Electronic Edition
 

Stark NJ, CRA Handbook, 2009 Electronic Edition, Clinical Device Group Inc, Chicago, IL (2009). Illustrated eBook on secured PDF. Link to downloadable file delivered by email; 3MB file size; Resides on your hard drive, fully searchable and easy to use. ISBN number 1-889160-21-0. $50 US.

The Electronic version of the CRA Handbook has been formatted for easy on-screen viewing and designed specifically for loading onto your laptop. The handbook is indexed for faster searching and is bookmarked for ready location of information.

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