Product Details
New 2022 Edition of Best Seller!
Meet the definitive guide to adverse event reporting in clinical trials: CenterWatch’s Clinical Trials Adverse Event Reporting Guide, 2022 Edition.
Now in its newest edition, this bestselling resource has helped countless clinical research professionals get to and maintain compliance.
To answer your every question on adverse event reporting, this guide incorporates all applicable FDA guidances — including the most recent. To these it adds the guidelines from the International Council on Harmonization (ICH) and the Office of Human Research Protections, to cover every aspect of reporting.
Need to know what kind of safety data to collect? What the FDA says qualifies as a reportable event? How to submit reports electronically?
In one convenient volume, you get 28 guidances with all the answers.
Stop overburdening the system by reporting events “just in case.” Stay compliant, protect your participants and allow sites, IRBs and the FDA to focus on the true adverse events. This updated edition will show you the way.
Turn to Clinical Trials Adverse Event Reporting Guide time and again when you need specifics on:
- How to report adverse events to your IRB
- How to establish and operate a clinical trial data monitoring committee
- How to handle unanticipated problems involving risks and adverse events
- Good pharmacovigilance practices
- Structure and content of clinical study reports
- How to file periodic benefit-risk evaluation reports
New in the 2022 edition
- Electronic Submission of IND Safety Reports — Technical Conformance Guide
- Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug and Cosmetic Act
- E2B(R3) — Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide
- E2D — Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
- E19 — Optimization of Safety Data Collection
Stay compliant by staying up to date with the newest adverse event reporting requirements. Do that with Clinical Trials Adverse Event Reporting Guide, 2022 Edition. Order your copy today.
Who Will Benefit
- Regulatory compliance officers
- IRB members
- Trial managers and investigators
- Directors of research and clinical operations
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ISBN-13:
978-1-60430-202-8
Publication date:
September 2022
Page count:
937
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