News

New courses on clinical trial safety reporting released

Wed 2 Nov 2022 @ 15:31

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of two new courses on safety reporting in clinical trials:

  • CT13: Safety Reporting in Clinical Trials
  • CT14: Clinical Trial Safety Reporting Requirements in the EU and USA

CT13 explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

CT14 sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by CT13 and provides greater detail of specific requirements in those jurisdictions. It is up to date with recent developments in the standardization of format and terminology for electronic safety report submissions to regulators.

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