CenterWatch Announces — Clinical Trials Adverse Event Reporting Guide, 2020 Edition Management Report

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Get official FDA, HHS and ICH answers to clinical trial adverse event reporting questions.

WCG CenterWatch

WCG CenterWatch

Clinical Trials Adverse Event Reporting Guide, 2020 Edition

2020 Edition Now Available!

Navigating the rules and procedures for protecting participants in clinical trials is challenging, especially when it comes to reporting adverse events.

Is one up to speed on the latest changes — from ICH E6(R2) to the recently revised Common Rule — that could affect one’s clinical trial reporting procedures? Does one know enough to build and maintain a compliant system?

The new edition of CenterWatch’s Clinical Trials Adverse Event Reporting Guide gives readers all the compliance references needed in one handy volume, including more than 20 guidances from the FDA, HHS and the ICH and text of all regulations pertaining to reporting adverse events in clinical trials.

New in the 2020 edition:

  • ICH E6(R2) — guideline on good clinical practice
  • ICH E3 — guideline on structure and content of clinical study reports
  • FDA guidance on Providing Regulatory Submissions in Electronic Format: IND Safety Reports and its technical conformance guide
  • FDA specifications for preparing and submitting electronic individual case study reports and attachments (ICSRs)
  • Working draft of the upcoming ICH E19 guideline on optimization of safety data collection
  • Revised Common Rule

Don’t miss out on having a go-to guide for clinical trial compliance.

Management Report Details:
Clinical Trials Adverse Event Reporting Guide, 2020 Edition

Management Report PDF:
Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600

About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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Michelle Butler
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