Inspection Readiness Toolkit

An inspection has been announced and you want to prepare the TMF for the inspection. What do you need to think of and what activities are typically conducted to prepare for the inspection?
These and many other questions have been addressed through the work that has been performed by the ‘Inspection Readiness’ TMF Reference Model subgroup. The scope of the work was to develop a toolkit of inspection preparation checklists, lessons learned and other resources that are available in the public domain. In particular, the subgroup discussed activities that organisations typically undertake to prepare for inspections and the roles performing those activities. The subgroup looked into different options to consolidate this and make it usable for other organisations.
The outcome is that the subgroup has gathered best practices for preparation of the TMF for inspection and these activities are listed in the Inspection Readiness RACI. The toolkit can be downloaded free of charge from our Resources web page.
The Inspection Readiness RACI can be used both for paper TMF, eTMF and hybrid TMFs. It can be adapted with the roles specific to the organisation using it and will help structure the inspection preparations and give a clear overview of activities, roles and responsibilities.

Is There Anybody Out There?

The TMF Reference Model was last updated in June 2015 so you may be thinking that all has gone quiet and nothing is happening. You couldn’t be farther from the truth! We currently have TWELVE sub-groups working on various initiatives concerning TMF management, involving around 90 members of the TMF Reference Model project team. These teams are all meeting as need to push forward their project. The ‘TMF Quality Control‘ group have completed their work and recently presented their draft output to the Steering Committee. The ‘Milestones’ group also presented their interim work to the Steering Committee to check they were aligned with the set objectives.
You can find details of all of the current work groups in our Roadmap but here’s the complete list:

  • eTMF Interoperability (eTMF Exchange Mechanism)
  • Reference Model Implementation Toolkit
  • Annual TMF Survey
  • Reference Model Upgrade User Guide
  • Metadata
  • Recommended Dating Conventions
  • Single-site Reference Model Template
  • Artifact Sub-types
  • Inspection Preparation
  • Milestones
  • Country-Specific Artifacts
  • TMF Quality Control

Some of these groups are nearing completion of their objectives but if you have an interest in getting involved, please contact us and we’ll put you in touch with the team lead. You need to be a member of the TMF Reference Model project team to join a team.

Changes to Steering Committee Membership

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

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?
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.

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

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.

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:

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 –
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.

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 . 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

Download Press Release

TMF Reference Model Review Period Open

At the TMF Reference Model Project team meeting today (Nov 17), the review period to prepare for v3 of the Reference Model was formally opened. All interested parties – whether members of the Reference Model Project or not – are encouraged to provide feedback on their use of v2.0 of the TMF Reference Model.
A spreadsheet template has been produced by the Steering Committee to capture feedback. Reviewers are asked to provide feedback in three areas (represented by three separate spreadsheets within the feedback workbook):

  • suggestions for NEW artifacts that they think are not currently included within the Reference Model;
  • feedback on existing artifacts within the Reference Model (comments on any of the columns within the existing model); or
  • general feedback about use of the model.

Feedback is requested by December 20, following which the zone teams will meet to review the feedback submitted. Instructions for completing and submitting the feedback are contained within the feedback template. Please also direct any other queries to:
f e e d b a c k @ t m f r e f m o d e l . c o m