ECAT


Error Capture and Action Tool (ECAT)


ECAT is an innovative technology from ICON that supports on-site Source Data Review (SDR). It is fully aligned with the proposed requirements of the upcoming GCP addendum ICH-GCP E6 (R2), and a key component of Patient Centric Monitoring, ICON’s methodology for a risk based adaptive approach to monitoring.  

  • Features an electronic checklist tool that delivers consistent, systematic SDR
    • Enabling predetermination of actions for detected non-compliance, based on impact and tolerance of anticipated errors
  • Has an in-built workflow for Human Factor Classification of root causes
    • Enabling advanced Root Cause Analysis and Corrective and Preventive Action of significant non-compliance
  • Provides detailed oversight, analysis and trending of errors in critical data and processes classified by site and country, as well as by study procedure
    • Increasing investigator oversight and review of action item
    • Detailing project oversight of errors at site, country, as well as project compliance and data driven support for interventions


Consistent Source Document Review
ECAT supports the shift from source data verification to source document review, which puts the focus on the site organisation’s understanding of the protocol and GCP compliance requirements to conduct the study. It uses an electronic checklist developed at the outset as part of the risk analysis and error management planning for the study. The risk analysis identifies and targets the critical study data and processes to assess the impact and probability of risk and this is used to define thresholds and mitigation strategies. The CRA then uses the checklist to guide and formally structure source document review during site monitoring.

Better analysis of errors to remove significant non-compliance
ECAT uses a best practice root cause analysis approach designed to identify the true human factors contributing to the site error, and a tailored corrective and preventive action for mitigation in line with section 5.20.1 of the new GCP requirements.

Increased investigator oversight and interaction  
ECAT includes a dynamic workflow to support efficient monitoring trip reporting and improves the delivery of site action items to the investigator via a site portal. The error reports are reviewed within ECAT and are delivered to the site portal for review and acknowledgement by the Investigator. This ensures that the investigator can individually supervise errors in (delegated) tasks through an investigator portal.

Enhanced transparency of site performance and compliance with trending and analysis
A key benefit of using ECAT is the ability to categorise and track each type of error within the system. This improves compliance and streamlines the sponsor/CRO oversight of compliance.  Tracking and categorising errors, allows better trending and analysis of these errors, analysis of site KPIs, and ranks sites based on risk profile and errors. The examples below demonstrate some of the analytics that are being used to analyse site quality, performance and compliance from monitoring visits:

ECAT error trending by Region and Country:
A key benefit of using ECAT is the ability to categorise and track each type of error within the system. This improves compliance and streamlines the sponsor/CRO oversight of compliance.  Tracking and categorising errors, allows better trending and analysis of these errors, analysis of site KPIs, and ranks sites based on risk profile and errors.