Ensuring Clinical Data Integrity: eCRF Validation

stock-footage-portrait-young-female-hospital-doctor-using-computer-to-input-data-on-clinical-trialsLast week, ARITHMOS hosted a symposium on eCRF, and Stefano Piccoli, Director of IT QA & Compliance, gave a presentation on ensuring clinical data integrity through validated eCRF. Stefano’s presentation looked at GCP requirements for source data, the risks of relying on sources like Excel or Access to manage data and how eCRF can help ensure data integrity.

According to ICH E6 Good Clinical Practice, “all clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification”.

This means that data must be:

  • Accountable/Attributable
  • Have an audit trail: proof of authenticity, details of computer system configuration, reports changes, records dates/times
  • Available for the life cyle of the data
  • Have back-up and recovery
  • Accurate and reliable
  • Have physical and logical security

When clinical trial Sponsors are on tight budget restrictions, they may implement data collection methods such as Excel spreadsheets and Access databases with data sent via email. Risks associated with this method include:

  • Lack of compliance
  • Data is not secure: limited permission controls and protection
  • Errors go unnoticed: data entry error can easily go undetected
  • No central location for forms and data
  • Database is often not validated
  • Data is not available in real time

Electronic Record Solution

Electronic records cover appropriate measures for clinical trial data: security, integrity and traceability

An eCRF (electronic case report form) is a secure, efficient and cost-effective solution for collecting clinical data. Web-based solutions provide data security through an HTTPS secure protocol and proper access roles and security settings. In terms of traceability, eCRF solutions have audit trails, time stamps and electronic signatures. More importantly, data are stored in a compliant data center with a back-up and disaster recovery plan.

Data integrity is not only an efficient way to conduct clinical research, it is a regulatory requirement. It can be ensured through choosing a proper technical solution which enables data security and traceability as well as appropriate computer system validation  and maintenance.


ARITHMOS has a proprietary, web-based EDC system, Symphony EDC, which has all the main functions of an EDC system and is customizable. The system provides an audit trail and secure, web-based data collection and data transfer. Customized reporting and real time access to data allows Sponsors of clinical trial to perform edit and discrepancy checks and make quick decisions on clinical trial progress.


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