Join Zack Schmidt, CEO, SureClinical and Chet Ensign, OASIS Chief Technical Community Steward in a live webinar on Thursday, August 13, 2020 at 12pm EDT (5pm BST/UK).
Digital transformation is well underway in clinical trial management as most Sponsors and CROs are moving towards electronic Trial Master Files (eTMF) and other digital solutions to manage their trials. But, there is a learning curve to understand and ensure interoperability, eTMF data sharing and standards. This webinar will explore flexible standards-based approaches to consistently and seamlessly share your eTMF data with partners, vendors, Sponsors and CRO’s.
Participants will receive an eTMF Best Practices certificate.
What you will learn
- Why standards are important to enable eTMF interoperability
- How standards makes it possible to consistently and seamlessly share your data with partners, vendors, Sponsors and CRO’s
- Difference between standards and models
- TMF structures and agency requirements
- How an electronic filing structure differs from a paper filing plan
- Introduction to eTMF content tagging using standards-based terms based on standards body definitions by NCI, FDA, HL7 and CDISC and others.