Changes to Steering Committee Membership

Following the recent Steering Committee elections, we are pleased to announce the new committee, effective 31 March 2016:

Elected/Re-elected:
Karen Roy – Phlexglobal
Eldin Rammell – Consultant
Martin Thorley – Pfizer
Allison Varjavandi – Astellas

Continuing members:
Jamie Toth – Daiichi Sankyo
Claire Mooney – Quintiles
Fran Ross – Consultant
Lisa Mulcahy – Consultant
Karin Schneider – J&J
Mike Czaplicki – GSK
Todd Tullis – Veeva
Kathie Clark – Wingspan
Jane Twitchen – Biogen
Eric Rubinson – Actavis / Allergan

The next election of all registered project team members will be scheduled for February 2017, to be effective 31 March 2017.

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Should Drafts be Retained in the TMF?

Based on responses from members of the TMF Reference Model project team, this question has now been included in our Frequently Asked Questions page. A summary is also provided below:

Question: Should draft documents be filed in the Trial Master File?
Answer:
Unanimous opinion across the TMF Reference Model is that draft versions of documents should not be kept in the TMF, including prior versions with tracked changes.

Key reasons include:

  • Maintaining drafts and annotations can highlight issues that don’t exist such as comments not followed up or opinions not agreed with;
  • There is no obligation to action all comments on a draft version;
  • European Directive 2003/63/EC contains the requirement to retain “all written opinions on the protocol and procedures”, but not drafts;
  • Documentation / correspondence should demonstrate that the review process has been followed; and
  • Retention policy may dictate that drafts are destroyed.
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Changes to Steering Committee Membership

Following the expiry of the initial term of office for some TMF Reference Model Steering Committee members, an election was recently held of all members registered with us (541 members). We are pleased to announce the Steering Committee members:

Positions only due for revote in January 2016:
Karen Roy – Phlexglobal – Chair
Steve Scribner – Consultant – Deputy Chair
Eldin Rammell – Consultant – Secretary
Tamika Jackson – Consultant

Renewed members:
Jamie Toth – Covance
Claire Mooney – Quintiles
Fran Ross – Consultant
Lisa Mulcahy – Consultant
Karin Schneider – J&J
Mike Czaplicki – GSK
Todd Tullis – Veeva
Kathie Clark – Wingspan

New Members:
Jane Twitchen – Biogen
Eric Rubinson – Actavis / Allergan

We would like to formally thank those who are stepping down for their hard work:

Paul Fenton
Martin Thorley
Steve Bioty
Jennifer Gaskin
Colleen Maude
Sam Mowaswes

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The 2015 TMF Survey Results are Available

We are pleased to announce that the results from the annual TMF Survey have been analysed and the summary report can be downloaded for free HERE.

Some of the highlights that you can find in the report:

  • Only 8% of respondents report NOT having an SOP for TMF Management.
  • Although most TMF seem to contain a similar number of artifacts that are present in the TMF Reference Model, some report having over 800 artifacts listed.
  • Whilst ICH GCP only mandates 5 documents being signed, some organizations require signatures on over 100 unique content types.
  • Use of eTMFs continues to grow.
  • Organizations using more than system for managing TMF content find problems with content reconciliation and end-users understanding where content is supposed to be.
  • Minimal use of purpose-designed electronic archive solutions.
  • Organizations are increasingly collecting cost metrics for TMF management.
  • Higher numbers than previously using the TMF Reference Model without changes.
  • 21% experiencing remote (off-site) inspections via an eTMF.
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Version 3.0 of the Trial Master File Reference Model is HERE!

Building on the most widely leveraged standardized reference in TMF management today – with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors – version 3.0 of the TMF Reference Model (released at the DIA Annual Meeting in Washington, DC on June 16th) incorporates feedback from this extensive industry use to enhance content clarity.   Highlights of V 3.0 include:

  • Updated artifacts – Additions, deletions, consolidations
  • Updated zones – Zones have been reassessed for logical artifact inclusion – E.g. local labs
  • Updated definitions – That more accurately describe the TMF RM components
  • Sub-artifact examples – assists with mapping to and understanding purpose of artifacts
  • TMF Reference Model User Guide – Provides step-by-step process for mapping your organization’s TMF to the TMF RM

An improved presentation of the model will also be available soon after the release to facilitate easier navigation.

In addition, by Q4 2015, an XML-based mechanism for simplifying the interchange of electronic TMF content between organizations will be added.

Join us at the DIA Annual Meeting

TMF RM members will be networking at DIA and will be holding a ‘Meet & Eat’ in the Community Networking Area on Tuesday the 16th at 12:30pm.  This area is adjacent to the Member Lounge and both are near the Lunch Voucher Pick-up at the entrance to Hall B in the Exhibit Hall. 

Additional Information is available at:  http://tmfrefmodel.com

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2015 TMF Survey Ready for Your Input

Make sure your perspective is heard, and get valuable insights and data for your Trial Master File (TMF) improvement initiatives. An outgrowth of the volunteer TMF Reference Model initiative, the 2015 TMF Survey is designed to provide year-over-year insights from sponsors, CROs, inspectors, and trial sites, for both paper and electronic TMF management. This is the only non-commercial TMF survey conducted by and for the TMF stakeholder community. The intent is to identify TMF trends, assess changes in industry directions, and measure the impact of TMF practices. Survey link – https://www.surveymonkey.com/s/TMF2015

Completion takes ten minutes or less, depending on your organization. All respondents who complete the survey and provide contact details will be sent the results; no participant is identified in the results.

The TMF Survey is developed by volunteer members of the TMF Reference Model initiative. Information about the group and our work is available at the end of the survey, and can also be found here on this site.

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Version 3.0 of the Trial Master File (TMF) Reference Model to be released at the Drug Information Association Annual Meeting in Washington, DC on June 16, 2015

PRESS RELEASE – March, 2015

What’s coming in 3.0?

Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, the next major release of the TMF Reference Model will incorporate feedback from its extensive industry use to enhance content clarity and add a XML-based mechanism for simplifying the interchange of electronic TMF content between organizations.

The V3.0 development team is currently composed of nearly 100 experts, and more volunteer participation is always welcome. To get involved, please visit https://tmfrefmodel.com/join-the-tmf-reference-model-project-team/join-here/ . We welcome your participation, insight and feedback.

What is the TMF Reference Model?
The TMF Reference Model provides a single, unified interpretation of regulations and TMF practices that has been vetted across the industry. Since its origination in 2009, the TMF Reference Model is managed by a group of Drug Information Association volunteers, comprised of over 350 contributors from more than 200 life science organizations and is a non-profit, vendor-agnostic initiative. The TMF Reference Model presents a consensus position in accordance with industry opinion regarding the standard content of a Trial Master File, to include identifying all the content that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
The TMF Reference Model allows for standardization of contents, structure, naming and metadata. The most obvious benefit of standardization is increased efficiency of gathering, managing, and analyzing trial content, but additional benefits of standardization include increased inspection surety and reduced variability when collaborating with business partners. As it does not prescribe any specific structure, nor define the processes required to create or manage TMFs, it can be adapted to any electronic or paper TMF and does not endorse, nor require, any specific technology for application.

The TMF Reference Model is a valuable tool for:

  • Life science clinical trial sponsors of any size, both commercial and institutional
  • Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
  • Contract Research Organizations and vendors servicing TMFs, including technology providers
  • Site staff, including investigators and coordinators
  • Regulatory inspectors and auditors who conduct trial inspections and audits

—END—

Download Press Release

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