Zack Schmidt, CEO, SureClinical was joined by Chet Ensign, OASIS Chief Technical Community Steward in a live webinar on Wednesday, 14 October 2020.
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 explored flexible standards-based approaches to consistently and seamlessly share your eTMF data with partners, vendors, Sponsors and CRO’s.
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.