In recent years there has been an increase in 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. This heightened attention has created the need for Sponsors to understand their audit data more completely and create a plan for management.
In this session, Cat Hall, VP Data and Quality will present the top considerations for building a successful IRT audit data management plan.
- Discover what is different about an Interactive Response Technology (IRT) audit log.
- Learn about computerized audit logs and how they relate to an audit trail.
- Review regulatory requirements and other guidelines to consider when managing IRT audit data.