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An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
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Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
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Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE

Joanna Black1, Patrick Julier2, Lucy Eldridge2

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Summary

A new REDCap module streamlines serious adverse event (SAE) reporting in clinical trials. The eSAE Project reduces errors and delays by auto-populating data and highlighting updates for timely sponsor review.

Keywords:
REDCapRegulatory complianceSAE collectionSAE processingSAE reportingSUSAR

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Area of Science:

  • Clinical Trials Technology
  • Pharmacovigilance Systems
  • Regulatory Compliance in Research

Background:

  • Electronic data collection (EDC) systems must ensure regulatory compliance and Good Clinical Practice (GCP) for accurate safety data reporting.
  • Timely reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) is critical in clinical trials of investigational medicinal products (CTIMPs).
  • Manual re-entry of adverse event (AE) data for SAEs introduces risks of errors and reporting delays.

Purpose of the Study:

  • To develop an efficient electronic system for managing SAEs within a UK academic clinical trials unit.
  • To enhance the timely and accurate reporting of safety data in CTIMPs using an open-source EDC system.

Main Methods:

  • A multi-disciplinary team developed a module within the REDCap EDC system.
  • The module integrates AE and SAE reporting functionalities.
  • Embedded code was implemented for visual tracking of data updates.

Main Results:

  • An electronic SAE reporting module was created in REDCap, automatically triggering SAE forms from AE forms.
  • Pre-population of relevant fields in the SAE form minimizes data entry errors and delays.
  • An embedded feature provides instant visual recognition of data updates, facilitating timely sponsor review and resolution.

Conclusions:

  • The eSAE Project in REDCap offers a novel approach to SAE reporting by auto-populating data from initial AE forms.
  • The system highlights updates to SAEs, enabling sponsors to efficiently reassess and process information.
  • This enhances compliance with UK regulatory reporting requirements for clinical trials.