Why is a stand alone index 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 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).
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
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 document or artifact types 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 (that are not clinical trials) while remaining as consistent as possible with the TMF-RM format and structure. The RWS-DI adapted the TMF RM and removed 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 supported by the TMF Reference Model Steering Committee throughout its development and approved by them prior to being launched to the wider research community as a ‘stand-alone’ deliverable. It is anticipated that, as it becomes widely adopted, the RWS-DI will evolve to reflect user community requirements. Feedback, inquiries, and suggestions for improvements for incorporation in future versions can be made using the RWS mailbox: email@example.com or by contributing to our online discussion forum.
The Real World Studies Working Group is 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, 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 [Currently-Director and Founder, Jeff Kirsch Consulting Ltd]
Stuart McCully, Founder, Phoenix RWR
Linda Rudolph, Principal Consultant, Quality Werx, LLC
The Real-World Studies Document Index can be downloaded for free from our Resources page.