The Real World Study-Document Index (RWS-DI) is a framework developed by a working group of RWE experts to address the challenges of filing essential documents for non-interventional and observational studies. The RWS-DI is designed to be consistent with the TMF Reference Model (TMF RM) format and structure, but removes artifacts specific to clinical trials and replaces terminology to reflect the unique nature of real-world studies.
 
Key differences between the TMF Reference Model (TMF RM) and the Real World Study-Document Index (RWS-DI) are:
 
[1] TMF Reference Model:
– An industry-adopted reference structure for the TMF that takes the form of an index.
– Provides a model of a complete TMF, which can then be customized as needed for a specific clinical study.
– Assigns documents to a comprehensive taxonomy complete with standard nomenclature to enable consistent filing.
– Developed primarily from a sponsor perspective, which makes it difficult for sites to adopt due to its larger scope and non-intuitive terminology.

Link: https://lnkd.in/eV4cH4At
 
[2] Real World Study-Document Index:
– A framework developed by a working group of real-world study (RWS) experts to address the challenges of filing essential documents for non-interventional and observational studies.
– Based on a prospective study design to provide maximum coverage of the potential document or artifact types across the range of real-world study designs.
– Designed to be consistent with the TMF RM format and structure, but removes artifacts specific to clinical trials and replaces terminology such as “trial” with “study” and “subject” with “patient.”
– A stand-alone deliverable that is expected to evolve to reflect user community requirements.

Link1: https://lnkd.in/eNUnsKR6
Link2: https://lnkd.in/eU6vf8qN
 
Overall, it is important for organizations to understand the regulatory requirements for TMF management and determine which framework is best suited for their specific study design.