Announcing: Real-World Study Document Index

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: stuart.mccully@phoenix-rwr.co.uk 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.

Announcing: Guidance for Managing Trial-related Emails

TMF Reference Model “Guidance for the Management of e-Mail Communications in Clinical Studies” v1.0 Published 31-Jul-2020

This “Guidance for the Management of e-Mail Communications in Clinical Studies” is intended to provide recommendations to the life sciences industry on the management of e-mail communications generated throughout the conduct of a clinical study.  Topics covered include:  best practices for managing e-mail, responsibility for the filing of e-mails, handling e-mail attachments, e-mail threads, periodic review, e-mail archiving and preservation, and regulatory expectations and citations.

Please note that this document is intended solely as guidance and is not intended to be prescriptive or to be interpreted as mandated by regulation or legislation. It is based upon the collective experience, knowledge, and best judgment of members of the TMF Reference Model e-Mail Communications Sub-Group as well as direct feedback and approval from the TMF Reference Model Steering Committee.

The recommendations in this guidance should be adapted to reflect the needs of each organisation’s own specific requirements.

The e-mail Communications subgroup started in October 2019 and comprised the following members:

NameOrganization
Shah AshrafTransperfect
Mary Ann BrooksBaxter Healthcare Corporation
Kathie ClarkEnnov
Dickson D’souzaIQVIA
Cynthia PintoGSK
Tiffany StewardAstellas
LoriAnn VernaJustInTimeGCP
Jennifer WilsonSyneos Health
Jamie TothDaiichi Sankyo, Inc.
Russell JoyceHeath Barrowcliff Consulting
Mark MercerCGI

If you have feedback on the guidance, please add a question or comment in our online discussion Forum.

Steering Committee Elections

Elections to fill the five vacancies on the Steering Committee will open at 5pm BST on Monday 30th March 2020. All active project members (registered on groups.io) will receive an invitation to cast a vote for up to five of the eight candidates, with voting open until Friday 10th April 2020. Details about candidates can be found HERE.

Reminder: TMF Industry Survey Now Open



Please add your voice to the only non-commercial, annual industry-wide Trial Master File Survey!  Make sure your perspective is heard and get valuable insights and data for your TMF improvement initiatives. 

This survey – developed by the TMF Reference Model Project Team –  is designed to provide insight into TMF details and practices from sponsors, CROs, inspectors, and sites, for TMF management.  The intent is to identify emerging TMF trends, assess changes in industry directions, and measure the impact of TMF Reference Model.  Please take a few minutes to add your voice today by going to the Survey link here:  https://www.surveymonkey.com/r/2019TMF

As always, the survey is completely anonymous.



TMF Industry Survey Now Open

Please add your voice to the only non-commercial, annual industry-wide Trial Master File Survey!  Make sure your perspective is heard and get valuable insights and data for your TMF improvement initiatives. 

This survey – developed by the TMF Reference Model Project Team –  is designed to provide insight into TMF details and practices from sponsors, CROs, inspectors, and sites, for TMF management.  The intent is to identify emerging TMF trends, assess changes in industry directions, and measure the impact of TMF Reference Model.  Please take a few minutes to add your voice today by going to the Survey link here:  https://www.surveymonkey.com/r/2019TMF

As always, the survey is completely anonymous.

New Discussion Forum Launched

Our new online discussion forum is now available…. just click on the Forum link on the main menu.

Those who have been involved with the TMF Reference Model project for a while will know that we’ve used Yahoo!Groups for several years. However, it is not always so convenient having groups of users managed in different places and Yahoo! are about to make some major changes to Yahoo!Groups, meaning we will lose lots of functionality. So our forum on Yahoo!Groups will be closing down soon.

Just a few things to note about the new forum:

  • Everything posted on the forum is visible to the general public so be careful about sharing company confidential or personal information.
  • You have to be a registered subscriber to post and you need to be logged in to the website.
  • We expect posters to follow a few basic rules (these are shown in a ‘sticky post’ on the forum)… you are likely to be barred from posting if the forum is used to promote products or services, or to post links to blogs and other sites. The aim is to facilitate discussion on the forum.
  • You can visit the forum regularly to check for new topics and posts but if you are a registered user you can also subscribe to the forum and automatically receive alerts to new topics and posts.

Happy posting!!

Changes to TMF Reference Model Steering Committee

Following the recent Steering Committee elections, we are pleased to announce the new committee, effective 1 May 2019:

Elected/Re-elected:
Karen Roy – Phlexglobal
Marie-Christine Poisson – Pfizer
Sholeh Ehdaivand – LMK Clinical Research Consulting
Allison Varjavandi – Astellas

Continuing members:
Jamie Toth – Daiichi Sankyo
Fran Ross – CGI
Lisa Mulcahy – Mulcahy Consulting LLC
Scott McCulloch – InClin
Todd Tullis – Veeva
Paul Fenton – Montrium
Wendy Trimboli – Eisai
David Ives – Alexion
Kathie Clark – IQVIA
Russell Joyce – Heath Barrowcliff Consulting

The next election of all registered project members will be scheduled for February 2020, with the new committee effective from 31 March 2020.

MHRA Q&A Document Revised

Following the receipt of clarification from the MHRA on access to the investigator TMF, the Q&A document that was generated following the European TM Summit has been revised. The document has been updated as follows.
“Slides were based on the draft of the TMF guidance at that time. The Q&A question 27 answer is compatible and clarifies why remote access to such information would not be acceptable. The guidance since then has been subject to some revisions. For remote access, the following is now stated:
‘Remote access by sponsor or CRO personnel to the investigator TMF should only be possible to the documents where personal data that enable the data subjects to be directly identified (i.e. direct identifiers of trial subjects) is not present or has been pseudonymised’.”
The full Q&A document is available to download from our Resources page.

FREE Webinar: Embracing the TMF Exchange Mechanism Standard

Final reminder that our next free Exchange Mechanism Standard (EMS) webinar is on Thursday December 13 at 7am PT, 10am ET, 3pm UTC, 4pm CET, kindly hosted by Wingspan Technology (an IQVIA company). Learn about the key success factors facing life sciences professionals in embracing the emerging TMF Exchange Mechanism Standard.
Register directly by clicking HERE.