SAE Reporting functionality for Large NIS Studies

In response to the anticipation of 15,000 Serious Adverse Events (SAEs) in a large Non-Interventional Study (NIS), the Sponsor sought a solution to streamline SAE reconciliation efforts throughout the study. The goal was to efficiently inform Pharmacovigilance, subcontracted to a CRO and Sponsor, about the status of SAEs. The project involved the creation of SAE reports, based on templates provided by the Sponsor, using data already collected in the Electronic Data Capture (EDC) system. These reports were automatically generated and sent to Pharmacovigilance and Sponsor representatives. Additionally, SAE Follow-up reports were numbered, and changes to data were highlighted. Both the initial and follow-up reports needed to be emailed to the study team.

🎯 Challenges

The current process involved filling out a paper SAE form and sending it to Pharmacovigilance, Medical, and Sponsor teams within 24 hours of the SAE occurrence or the investigator's awareness.

SAE reconciliation between EDC and the Safety database was labor-intensive due to data coming from different sources, including paper documents reported to Pharmacovigilance and entries in the AE form of the EDC.

💡 Solution

Creation of dynamic SAE reports (PDF) using data from the EDC and automated email notifications with PDF attachments.
Automation of SAE initial and follow-up reports, ensuring immediate notification to Pharmacovigilance and Sponsor.
Automatic generation of SAE reports upon detecting changes to predefined parameters, with email notifications sent after a configurable time interval.
Automated email alerts notifying the team of follow-up reports and highlighting new data in yellow.

🌟 Results

Smooth SAE reporting management, ensuring timely and accurate data reporting as required by health authorities.

Simplified and expedited SAE reconciliation between Data Management and Pharmacovigilance.

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