Ensuring the Adequacy of the Informed Consent Process in GCP Regulated Environments

November 15, 2019
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FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments

This white paper examines the key points of the guidance and the thinking behind the FDA’s 2009 “Guidance f...

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Simplifying CAPA: Seven Steps
Simplifying CAPA: Seven Steps

A comprehensive CAPA process consists of seven key actions that should be tracked and documented.