CRA Handbook 2011 Electronic Edition
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| Stark NJ, CRA Handbook, 2011 Electronic Edition, Clinical Device Group Inc, Chicago, IL (2011). The illustrated e-book is offered as a secured non-printable pdf Acrobat document. Designed to upload to your hard drive, be fully searchable, and annotate-able with Acrobat Writer; the 3MB file is delivered by email. ISBN number 1-889160-25-3. $50 US. |
The electronic version of the CRA Handbook is formatted in 10-point Verdana type for easy on-screen viewing. Provided as an Acrobat pdf document, it is designed specifically for loading onto your laptop or other hard-drive. The handbook is indexed for faster searching and is bookmarked for ready location of information. It is fully annotate-able if you have Acrobat Writer—a big plus if you like to make field notes. It is not printable.
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 16] FDA Guidances
[Figure 1] US Studies under the Investigational Device Exemptions
[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] Poststudy 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)