Adverse Event Reporting to IRBs – Best Practices to Follow
Abstract:The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects.
This article describes the best practices to be followed in order to comply with the FDA's new guidelines on adverse event reporting to IRBs.
Compliance Trainings
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
By - Rachelle D Souza
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By - Rachelle D Souza
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Trial Master File and Clinical Data Management Regulated by FDA
By - Carolyn Troiano
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Annual Current Good Manufacturing Practices (cGMP) Training
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