The Study Master File
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).
Why do we need a Real World Study – Document Index (RWS-DI)?
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 Solution
In designing the Study Master File Template (also known as the Real World Study – Document Index, RWS-DI), the group took into account the ethical standards, regulatory requirements, guidelines and industry best practices applicable to 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.
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: Non-interventional studies, non-IND studies, observational studies, disease registry studies, PASS, retrospective chart reviews etc
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