This is a Document Index (read ‘TMF’) specifically intended for use with Real World Studies that has been adopted from the TMF Reference Model.

• Version = v1.0
• Approved by the TMF Reference Model Steering Committee on 29 July 2020

Notes:

• This is the distilled version of the RWS-DI that is posted on the TMF Reference Model website (see link below).
• We call this the “distilled” version because it doesn’t contain the guidance text, glossary or information on the scope of the Document Index.

Think of this as the raw data (Distilled RWS-DI) plus all the additional guidance and instructions for use. Useful for anyone who wants to understand the scope of the Document Index and Real World Study context of the Sections, Zones and Artifacts.

The ‘Detailed’ RWS-DI includes:

• The Distilled RWS-DI
• + Guidance and Context on How to Use the Document Index
• + Details of the Types of Real World Studies that the RWS-DI was designed to support
• + A Glossary of Terms