Driven by increased regulatory scrutiny from clinical trial governing agencies, with a particular focus on the validation of computer systems and the need for verification of data integrity and reliability through audit trail review, the need has arisen for a validated system that provides IRT transaction audit log data for each site and delivers data files to Investigators directly in a GXP-compliant and secure platform.

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 DIAL Audit Data Management system provides the tool Sponsors need to enable Investigator access to audit logs post study close, outside the IRT system. 

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