Study Master Files

for Real World Studies

Download the Detailed Real World Study – Document Index (RWS-DI)

Tired of Trying to Force your Observational Study Documents into a Filing System Designed Specifically for Clinical Trials?

Over a two year period (2018 to 2020), a team of Real World Study subject matter experts spent significant time and effort developing the study master file template for Real World Studies (also known as the Real-World Study – Document Index, RWS-DI). The template was adapted from, and aligned with, the DIA TMF Reference Model structure.

The result is a listing of core and recommended artifacts relevant to Real World Studies, providing a much needed framework for those conducting these types of study.

The Real World Study – Document Index, is available in two form:

a distilled version, which is available to download for free from the TMF Reference Model website; and
a more detailed and comprehensive version, which is available to download for free here.

To learn more about the Real World Study – Document Index and the two version on offer please click here.

End users have been waiting for many years for a real world study equivalent of the TMF-Reference Model (TMF-RM), as indicated by the 78% of those who conduct studies saying they were very likely or likely to use the RWS-DI (TMF-RM General Meeting 22 June 2020)

Study Master Files

Tired of Trying to Force your Observational Study Documents into a Filing System Designed Specifically for Clinical Trials?

Study Master File Template

Real World Research Studies

Real World Research...simplified

End users have been waiting for many years for a real world study equivalent of the TMF-Reference Model (TMF-RM), as indicated by the 78% of those who conduct studies saying they were very likely or likely to use the RWS-DI (TMF-RM General Meeting 22 June 2020)