The field guide for monitoring medical device clinical trials, the CRA Handbook contains full text copies of US regulations, excerpts and checklists of ISO 14155 requirements, tables, charts, and other stuff you need to look up when you’re away from the office. Comb-bound and compact, it's designed to fit in a briefcase, lie flat for easy reading and lend itself to field notes. No monitor should be without one!

Contents
[Ch 1] 21 CFR Part 812—Investigational Device Exemption Regulations
[Ch 2] 21 CFR Part 814.20 Subpart B—PMA Approval of Medical Devices
[Ch 3] 21 CRF Part 11—Electronic Records; Electronic Signatures
[Ch 4] 21 CFR Part 50—Protection of Human Subjects
[Ch 5] 21 CFR Part 54—Financial Disclosure by Clinical Investigators
[Ch 6] 21 CFR Part 56—Institutional Review Boards
[Ch 7] 21 CFR Part 99—Dissemination of Information on Unapproved/New Uses….
[Ch 8] 21 CFR Part 809—In Vitro Diagnostic Products
[Ch 9] 21 CFR Part 820.30—Quality System Regulation
[Ch 10] Expedited Review List
[Ch 11] FDA Guidelines for the Monitoring of Clinical Investigations
[Ch 12] Overview of the Monitoring Process
[Ch 13] Declaration of Helsinki (2008)
[Ch 14] ISO 14155 “Clinical Investigation of Medical Devices in human subjects—good clinical practices” (2011) (excerpts)
[Ch 15] Adverse Events & Effects
[Ch 06] FDA Guidances

[Figure 1] Flowchart for IDEs
[Table 2] Comparison of Abbreviated and Full IDE Requirements
[Figure 3] Oral Informed Consent
[Figure 4] Financial Disclosure by Clinical Investigators
[Figure 5] Overview of the Monitoring Process
[TAble 6] Prestudy Documents
[Table 7] Study Documents
[Table 8] Post-study Documents
[Table 9] Data Management Documents
[Table 10] Statistical Analysis Documents
[Figure 11] Device Design Process in the EU
[Figure 12] ISO 14155 Clinical Investigations in the EU
[Figure 13] AE Reporting for NSR Studies under Part 812
[Figure 14] AE Reporting for SR Studies under Part 812
[Figure 15] AE Reporting under ISO 14155 (2011)