Want to create interactive content? It’s easy in Genially!
AE Communication
Allison Stone
Created on October 24, 2024
Start designing with a free template
Discover more than 1500 professional designs like these:
Transcript
During Adverse Event Reporting
start
Inadequate Communication
Inadequate Communication During Adverse Event Reporting
next
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.
Scenario
There was no system in place for regular updates and reminders about AE reporting.
CRAs did not seek clarification on the reporting process.
The data management team did not provide comprehensive training on AE reporting requirements.
Issues
Inadequate Communication During Adverse Event Reporting
next
Finish
The sponsor's reputation was damaged, affecting future collaborations and trials
The trial faced scrutiny from regulatory authorities, risking fines and sanctions.
Delayed AE reports led to regulatory non-compliance and potential safety risks for participants.