Speaker:
• Eduardo Morales, Systems Designer – Enterprise Research Infrastructure & Services (ERIS)
This session reviews the Adverse Event Reporting module developed by Eduardo Morales of the REDCap team. This module is designed to generate Adverse Event reports needed by investigators at different time points for different requirements. It can connect and load data from an existing REDCap project or it can act as an additional REDCap project that collects AE data.
The REDCap AE Reporting External module can facilitate Investigator and Institutional compliance by facilitating the creation of aggregate Adverse Event (AE) reports for:
- ClinicalTrials.gov (CTgov) AE results reporting module
- Aggregate AE reporting to your Institutional Review Board (IRB)
- Summary AE reporting for the Food and Drug Administration (FDA)
Learning Objectives:
- Learn the basics of the module functions
- Learn how to set up the module in REDCap
- Learn how the module is applied to a real example project
Target Audience: Researchers whose projects require reporting adverse events to one of the previously mentioned organizations