Sick and Tired of Trying to (Painfully) Force your Observational Study Documents into a Filing System Designed Specifically for Clinical Trials?

TMF Index for Observational Studies

Those of you who are involved in Real World Studies (RWS) know that trying to file your documents using the existing TMF Reference Model (TMF RM) based on ICH E6 can be challenging. Your study isn’t a clinical trial and as a result, at least 40% of the artifacts in the index are irrelevant. The result? You start from the beginning every time you set up a new study and ‘switch off’ the tabs that aren’t applicable. Alternatively, you may be required to use the existing TMF RM per your organisation’s policy, and document which tabs aren’t relevant. Additionally, you hope that an auditor of your ‘real world study TMF’ understands your type of study and doesn’t penalize you for missing documents (or documents that were never generated, because your study is not a clinical trial).

In 2016, I approached the steering committee of the TMF Reference Model with a concern and an observation…we didn’t have a TMF equivalent for clinical studies that weren’t clinical trials, such as observational studies. 4 years later, after much work and effort by a team of subject matter experts (the RWS-DI team)…the ‘Real World Study – Document Index’ was published.

Why do we Need a TMF Index for Observational Studies?

With the increasing use of these types of studies to support drug development, product licensing, label claims and reimbursement, the need for an audit-ready framework, referencing the documents that evidence the integrity of the study conduct and data, has become a critical requirement.

Designing a TMF Index for Observational Studies

In designing the TMF Index for Observational Studies (officially known as the Real World Study – Document Index [RWS-DI]), we (the RWS-DI team) took into account the ethical standards, regulatory requirements, guidelines and industry best practices applicable to observational and non-interventional studies (NIS).

The RWS-DI is 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, from non-interventional studies, retrospective chart reviews to prospective product registry studies and everything in between.

Learn More about the ‘Real World Study – Document Index’

Key Differences between the TMF Reference Model and the RWS-DI

Comparators TMF Reference Model RWS-DI
Applicability Clinical Trials Clinical Studies that are not Clinical Trials*
Zones 11 10
Sections 40 23
Artifacts 249 130
…of which “Core” 197 11
…of which “Recommended” 52 119
Terminology Trial Study
Terminology Subjects Patients
Terminology Safety Reporting Pharmacovigilance

*Examples of clinical studies that are NOT clinical trials include…Observational studies, non-interventional studies (NIS), natural history studies, pregnancy registries etc