The CDISC ISF Reference Model: How it Started, How it's Going

Session details:

Our industry would benefit in many ways from having an ISF standard that aligns with the TMF Reference Model - consistency, clarity, and compliance to name a few.  However, sites do not yet have an industry-recognized standard reference for their documentation, which amounts to inconsistent site document organization and inefficient translatability of site documents to the sponsor TMF.  The 2 co-leads for this initiative will talk about how it came to be and how it plans to transform the industry at the site level and beyond through standardization. In this session, you’ll hear about: 

• What it is and why it matters  
• Alignment with the TMF RM
• Progress and challenges  
• What's on the horizon