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#13 Practical RWE – Documentation: Trial Master File vs Study Master File

#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE)

 

Definitions are crucial in the context of real-world research (RWR), real-world data (RWD), and real-world evidence (RWE) for several reasons:

  1. Clarity and Precision: In research, clear definitions ensure that everyone understands exactly what is being discussed. This is particularly important in RWD and RWE, where the data comes from a variety of sources and might be interpreted in different ways.
  2. Consistency: Definitions help maintain consistency across studies. In the realms of RWD and RWE, where studies often use data collected for other purposes, having standard definitions allows for more reliable comparisons and aggregations of data.
  3. Data Quality: Good definitions help ensure high-quality data. In real-world research, where data is not collected in controlled experimental settings (e.g., randomised controlled trials), clear definitions are essential for filtering and processing data effectively.
  4. Regulatory Compliance: In many fields, particularly in healthcare and pharmaceuticals, RWE is used to support regulatory decisions. Precise definitions are critical to meet the regulatory standards for evidence.
  5. Interdisciplinary Communication: RWD and RWE often involve collaboration across various disciplines. Clear definitions facilitate better communication and understanding among diverse groups of researchers, clinicians, policymakers, and other stakeholders.
  6. Replicability and Scalability: Well-defined concepts and methods enable other researchers to replicate studies or scale up research projects. This is vital for the advancement of science and policy-making.
  7. Data Integration: In real-world research, data often comes from multiple sources. Consistent definitions allow for more effective integration and analysis of this heterogeneous data.
  8. Targeted Interventions and Policies: In applied research, such as public health or market research, clear definitions help in designing more effective interventions and policies, as they allow for a precise understanding of the phenomena being addressed.

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#13 Practical RWE – Documentation: Trial Master File vs Study Master File2024-02-01T16:04:58+00:00

Real World Evidence (RWE) – TMF Reference Model versus the Real-World Study Document Index (RWS-DI)

RWE 101 – TMF Reference Model versus the Real-World Study Document Index (RWS-DI)

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.

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Real World Evidence (RWE) – TMF Reference Model versus the Real-World Study Document Index (RWS-DI)2023-08-07T18:29:01+00:00

Real World Evidence (RWE) 101 – ISF vs TMF

RWE 101 – ISF vs TMF

Investigator Site File (ISF) and Trial (Study) Master File (TMF) are key elements in managing clinical and observational studies. They are distinct but interconnected, and play vital roles in ensuring the documentation, compliance, and overall management of a research study is handled properly.

[1] Investigator Site File (ISF): This is a collection of documents, images, and digital media that an investigator (or a site conducting the research) uses to record the administrative and procedural documentation related to the study. It includes items such as the protocol, study approvals, consent forms, participant information, communication records, and site-specific documentation. The ISF helps demonstrate the site’s compliance with the principles of Good Clinical Practice (GCP) and the applicable regulatory requirements.

[1] Trial Master File (TMF): This is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. It is intended to serve both the interests of the sponsor and the regulatory bodies. The TMF includes a broad range of information, such as the protocol, ethics committee approval, data safety monitoring board reports, informed consent forms, and any other relevant documentation. It should include all the key documents from the ISF, but also additional information at a study-wide level.

Key differences between the ISF and TMF include:

[1] Scope: ISF focuses on documentation at the site level, specific to each location where the study is conducted. TMF encompasses the entire study and includes all sites involved in the study, maintaining a complete record of all essential documents.

[2] Control: ISF is usually maintained by the investigator or staff at the site where the study is being conducted. The TMF, on the other hand, is typically managed and controlled by the study sponsor.

[3] Documentation: While both files hold critical study documents, the ISF is more focused on site-specific operational documents (e.g., informed consent forms), while the TMF has more strategic and overall study control documents.

[4] Purpose: While both files are crucial for audits and inspections, the ISF is particularly important for demonstrating the compliance of the individual site, while the TMF helps provide a comprehensive overview of the study’s conduct and ensures that the trial can be adequately reconstructed if necessary.

Please note that while these are general guidelines, the exact nature of the ISF and TMF may vary depending on the specifics of the study, the regulatory framework, and the procedures established by the sponsor.

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Real World Evidence (RWE) 101 – ISF vs TMF2023-08-07T18:20:46+00:00

Insights – Document Management and Archiving Requirements for Observational Studies

RWR CONTEXT

The TMF Reference Model’s specially designed Study Master File will not have an impact on the regulatory requirements for conducting real world research studies in the country of interest…but if used…it will make your real world research studies much easier to manage and less resource intensive (and less frustrating!).

5 NOVEMBER 2021 – Did you know that there is a DIA TMF Reference model for observational studies? 

  • [Lean Version] Real-World Studies Document Index Provides a proposed Document Index for use on real-world studies, based on the TMF Reference Model for clinical trials (v1.0 Approved 29-July-2020) [1]
  • [Detailed Version – with guidance notes] Study Master File [2]

For years, those of us who have been running observational studies (also known as non-interventional studies) have been the ‘poor relation’ with regards to document management tools and offerings.  We’ve had to ‘bootstrap’ existing clinical trial tools to fit the significantly different document requirements for observational studies.  This is why, in 2018 a group of frustrated experts got together with the blessing of the TMF Reference Model Steering Committee…and the rest, as they say…is history…

Why is a Stand Alone Study Master File Needed?

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 in accordance with your organisation’s policy and disregard tabs that aren’t relevant. Additionally, you hope that an auditor of your ‘real world study TMF’ understands your study and doesn’t penalize you for missing documents (or documents that were never generated, because your study is not a clinical trial).

Real World Studies are increasingly being used to support drug development, product licensing, label claims and reimbursement. Consequently the need for an audit-ready framework has become a critical requirement to effectively collect and manage the documents that evidence integrity in relation to study conduct and study data.

Designing a Solution

To address this, a working group of RWS experts* convened in March 2018 to develop a framework for filing essential documents for non-interventional and observational studies. In designing 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 group developed the RWS-DI based on a prospective study design to provide maximum coverage of the potential documents (or artifacts) across the range of real world study designs, from non-interventional studies, retrospective chart reviews, to prospective product registry studies.

The result is a listing of core and recommended artifacts relevant to Real World Studies (which are not clinical trials) while remaining  as consistent as possible with the TMF-RM format and structure. The RWS-DI adapted the TMF RM removing artifacts specific to clinical trials such as Investigational Product Dossier (IMPD) or Investigator’s Brochure (IB) and replaced terminology such as ‘trial’ with ‘study’ and ‘subject’ with ‘patient’.

The RWS-DI was sanctioned under the auspices of the DIA TMF Reference Model Steering Committee throughout its development. It was endorsed by the DIA TMF Reference Model Steering Committee as a ‘stand-alone’ deliverable for launch to the wider research community. It is anticipated that, as the RWS-DI becomes widely adopted, it will evolve to reflect user community requirements. Feedback, enquiries, and suggestions for enhancements for incorporation in future versions can be made using the e-mail address stuart.mccully@phoenix-rwr.co.uk.

The Real World Studies Working Group comprised of the following members, all of whom work within the Real-World Study environment and contributed their expertise throughout the duration of the project.

Shelley Brigstock Study Project Manager, Novo Nordisk

Kath Firth Head of Quality Operations, GSK

Tara Isherwood               Senior Director, Regulatory Advice and Delivery, Syneos Health

Russell Joyce Director and Principal Consultant, Heath Barrowcliff Consulting

Jeff Kirsch* Senior Director, Quality & Risk Management and Governance, GSK

Stuart McCully               Founder, Phoenix RWR

Linda Rudolph               Principal Consultant, Quality Werx, LLC

____________________________________________________

*Currently-Director and Founder, Jeff Kirsch Consulting, Ltd

Want to Learn More?

Speak to the Master Architect – Russell Joyce.  Russell is one of the founders of the TMF Reference Model and the chair of the Study Master File working group (Real World Study Document Index)

Email: russell@heathbarrowcliffconsulting.co.uk 

Web: https://heath-barrowcliff-consulting.co.uk/  

LinkedIn: https://www.linkedin.com/in/russell-joyce-18524918/  

References

1. Real-World Studies Document Index Provides a proposed Document Index for use on real-world studies, based on the TMF Reference Model for clinical trials (v1.0 Approved 29-July-2020)

Link: https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Deliverable-Real-World-Studies-Document-Index-v1-2020-07-29.xlsx 

2. Study Master File

Link: https://studymasterfile.com/rws-di-2/ 

Insights – Document Management and Archiving Requirements for Observational Studies2022-08-07T17:06:27+00:00
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