Safety Reporting in Clinical Trials

Online Course • grapl

About the CPD course

This course 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.

CPD Provider

grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.