Audit Data Management 

Investigator Access to IRT Audit Log Data in a Secure, GxP Compliant Platform

What is Audit Data Management? 

To maintain data oversight and ensure integrity, Health Authority guidelines require IRT audit log data to come directly to investigators without sponsors handling or managing the data in the process. To meet this requirement, IRT vendors must facilitate Investigator access to system audit logs post study close, outside the IRT system. 

Driven by this new regulatory guidance and industry need, Endpoint Clinical and partner, Egnyte™, have created the Audit Data Management platform – a validated IRT system integration that extracts IRT transaction audit log data for each site and provides these data files to Investigators directly in a GXP-compliant and secure platform. Thus, ensuring Investigators have the data they need to meet regulatory expectations. 

Benefits of Audit Data Management: 

  • Ensure GXP Compliance 
  • Access Secure Data Easily​ 
  • Maintain Data Integrity and Oversight 
  • Access and report historic data 

Features of Audit Data Management: 

  • Secure login prevents unauthorized access to confidential data. 
  • Easily traceable data gives valuable insight into file transactions- when they occurred, file details, and user information. 
  • Robust reporting provides access to historic audit logs, user activity and workflow transactions. 

WHITEPAPER: Securing the Integrity of Investigator-Owned Audit Trail Data

In this whitepaper, Cat Hall, Endpoint’s VP Data and Quality uncovers how to maintain data oversight, meet data integrity and regulatory expectations, and how Audit Data Management system provides the tool Sponsors need to enable Investigator access to audit logs post study close, outside the IRT system.