CRA Handbook 2018; Paper edition

We designed the CRA Handbook to put the clinical regulations, FDA guidances, ISO 14155 outline and task lists, and checklists of clinical trial documentation in one convenient location. People tell us their old electronic handbooks are full of ‘stickies’, margin notes, highlights, and folded corners as they mark the paragraphs important to them.

The 2018 version was revised to make the guidelines and guidance documents list more extensive and deleted less relevant documents. Futhermore, all chapters have been updated to the most recent version of the CFR. No updates have been made to the Declaration of Helsinki and ISO 14155 currently, so these chapters remained unchanged.

Stark NJ, CRA Handbook, 2018 Edition, Factory-CRO Group (2018).

Price: 55.00

Description

The field guide for monitoring medical device clinical investigations, the CRA Handbook contains full text copies of US regulations, excerpts and checklists of ISO 14155 requirements, tables, charts, and other resources you may need to research when you’re away from the office. Comb-bound, 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!

Table of Contents

Chapter 01  |  21 CFR Part 812 – Investigational Device Exemptions
Chapter 02  |  21 CFR Part 814.20 – Premarket Approval Applications
Chapter 03  |  21 CFR Part 11 – Electronic Records; Electronic Signatures
Chapter 04  |  21 CFR Part 50 – Protection of Human Subjects
Chapter 05  |  21 CFR Part 54 – Financial Disclosure
Chapter 06  |  21 CFR Part 56 – Institutional Review Boards
Chapter 07  |  21 CFR Part 99 – Dissemination of Information
Chapter 08  |  21 CFR Part 809 – In Vitro Diagnostic Products
Chapter 09  |  21 CFR Part 820.30 – Quality System—Design Controls
Chapter 10  |  45 CFR Part 160 – General Administrative Requirements
Chapter 11  |  45 CFR Part 162 – Administrative Requirements
Chapter 12  |  45 CFR Part 164 – Security and Privacy
Chapter 13  |  Expedited Review List
Chapter 14  |  Monitoring Task Lists and Documentation Checklists
Chapter 15  |  Declaration of Helsinki (2013)
Chapter 16  |  ISO 14155 (2011) Summary
Chapter 17  |  Adverse Events & Effects
Chapter 18  |  FDA Guidances

Figures
Figure 1. Flowchart for IDES
Figure 2. Oral Informed Consent
Figure 3. Financial Disclosure by Investigators
Figure 4. Overview of the Monitoring Process
Figure 5. Device Design Process in the EU
Figure 6. ISO 14155 Clinical Investigations in the EU
Figure 7. Adverse event reporting for non-significant risk (NSR) studies under 21 CFR Part 812
Figure 8. Adverse event reporting for significant risk (NSR) studies under 21 CFR Part 812
Figure 9. Adverse event reporting under ISO 14155 (2011)

Tables
Table 1. Comparison of Abbreviated and Full IDE Requirements
             Task lists:
Table 2. Pre-Study Visit
Table 3. Study Initiation Visit
Table 4. Routine Monitoring Visit
Table 5. Study Close-Out
             Document checklists:
Table 6. Pre-Study Documents
Table 7. Study Documents
Table 8. Post-Study Documents
Table 9. Data Management Documents
Table 10. Statistical Analysis Documents