AE Communication

Inadequate Communication

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During Adverse Event Reporting

Scenario

During a clinical trial, the communication between the clinical research associates (CRAs) and the data management team was poor. CRAs were unclear about the adverse event (AE) reporting timelines and procedures, leading to incomplete and delayed AE reports.

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Inadequate Communication During Adverse Event Reporting

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Inadequate Communication During Adverse Event Reporting

Issues

The data management team did not provide comprehensive training on AE reporting requirements.

CRAs did not seek clarification on the reporting process.

There was no system in place for regular updates and reminders about AE reporting.

Consequences

Inadequate Communication During Adverse Event Reporting

Delayed AE reports led to regulatory non-compliance and potential safety risks for participants.

The trial faced scrutiny from regulatory authorities, risking fines and sanctions.

The sponsor's reputation was damaged, affecting future collaborations and trials

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