CRA Handbook 2014; Electronic Edition

CRA Handbook 2014

Stark NJ, CRA Handbook, 2014 Electronic Edition, Clinical Device Group Inc, Chicago, IL (2014). The electronic edition is formatted for easy screen viewing and it fully annotatable with Acrobat Writer. 169 pages. ISBN 1-889160-26-1. $55 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, Smartphone, Dropbox, tablets, or other electronic readers. The handbook can be quickly searced using Acrobat's control F, and is bookmarked for ready location of information. It is fully annotateable if you have Acrobat Writer—a big plus if you like to make field notes. It is not printable!

Table of Contents
[00] Foreword
[01] CFR Part 812—Investigational Device Exemptions
[02] CFR Part 814.20—Premarket Approval Applications
[03] CFR Part 11—Electronic Records; Electronic Signatures
[04] CFR Part 50—Protection of Human Subjects
[05] CFR Part 54—Financial Disclosure
[06] CFR Part 56—Institutional Review Boards
[07] CFR Part 99—Dissemination of Information
[08] CFR Part 809—In Vitro Diagnostic Products
[09] CFR Part 820.30—Quality System—Design Controls
[10] Expedited Review List
[11] Risk-Based Monitoring—The New FDA Guidance
[12] Monitoring Task Lists and Documentation Checklists
[13] Declaration of Helsinki (2013)
[14] ISO 14155 (2011) Summary
[15] Adverse Events & Effects
[16] FDA Guidance List

Table of Figures and Tables
   [Figure 1] Flowchart for IDEs
   [Table 2] Comparison of IDE Requirements
   [Figure 3] Oral Informed Consent
   [Figure 4] Financial Disclosure by Investigators
   [Figure 5] Overview of the Monitoring Process

Task Lists:
   [Table 6] Prestudy Visit
   [Table 7] Study Initiation Visit
   [Table 8] Routine Monitoring Visit
   [Table 9] Study Close-out

Document Checklists:
   [Table 10] Pre-study Documents
   [Table 11] Study Documents
   [Table 12] Post-Study Documents
   [Table 13] Data Management Documents
   [Table 14] Statistical Analysis Documents

   [Figure 15] Device Design Process in the EU
   [Figure 16] ISO 14155 (2011) Clinical Investigations in the EU
   [Figure 17] AE Reporting for NSR Studies under Part 812
   [Figure 18] AE Reporting for SR Studies under Part 812
   [Figure 19] AE Reporting under ISO 14155 (2011)