Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

Abstract Background It is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal prod...

Full description

Bibliographic Details
Main Authors: Joanna Black, Patrick Julier, Lucy Eldridge, Vicki S. Barber
Format: Article
Language:English
Published: BMC 2024-07-01
Series:Trials
Subjects:
SAE collection
SAE processing
SAE reporting
SUSAR
REDCap
Regulatory compliance
Online Access:https://doi.org/10.1186/s13063-024-08317-0

Internet

https://doi.org/10.1186/s13063-024-08317-0

Similar Items