TMF Reference Model Review Imminent

As previously mentioned here, the formal review process to develop the next revision of the TMF Reference Model is about to kick-off. To support this process, the TMF Reference Model Steering Committee has released a slide deck to provide an overview of the process and what is needed to make the review successful.
The development of v3 of the Reference Model depends on contributions from as wide a variety of industry stakeholders as possible, including input from people with expertise in all areas, including the following:

  • sponsor TMF requirements
  • CRO TMF requirements
  • investigator site TMF requirements
  • device trials
  • diagnostics trials
  • drug trials

We are particularly keen to receive feedback from companies and organizations who have tried to implement the TMF Reference Model. A template will shortly be available for anyone to provide feedback but in addition we need:

  • volunteers to lead a small group of experts focussing on one of the Reference Model zones (Zone Lead)
  • volunteers to participate in reviewing the feedback for one of the Reference Model zones (Zone Member)
  • volunteers to participate in a technical team looking at the structure and format of the Reference Model spreadsheet itself (Technical Team Member)
  • volunteers to participate in a communications team looking at publicity, press releases, engaging with other groups etc (Communications Team)

If you would like to volunteer, please join the TMF Reference Model Team (if you are not already a member) and contact Karen Roy to put your name forward or send an email directly to    f e e d b a c k @ t m f r e f m o d e l . c o m

Spotlight on the TMF Reference Model

  • Industry accepted reference model for Trial Master File content
  • Version 3.0 development starting imminently – get involved!
  • Other initiatives – Usability, Metrics, Interoperability Quality

The Trial Master File Reference Model (TMF RM), a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community, is a collaborative reference for the contents of a TMF. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed through a volunteer effort that includes bio-pharmaceutical and device companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia and non-for-profit / NGO.  Membership has quickly grown and by August 2014, over 350 members from over 200 companies. The group is managed by an elected Steering Committee, members detailed below.
The TMF Reference Model provides a reference for the industry and should not be considered mandatory, but rather an opportunity for harmonization across the industry in terms of content, naming and structure. The MHRA, EMA and FDA were invited to review, and their comments were incorporated. The TMF Reference Model can be adapted to either an electronic or paper TMF.  It does not endorse, nor require, any specific technology for application.
The model can be downloaded from the DIA website. Although the DIA is fully supportive of the TMF RM, the work product of the group is in no way “owned”, governed, managed or endorsed by the DIA, hence DIA not being mentioned in its name.
Version 1 was published in 2010, version 1.1 (including Regulator feedback) in 2011 and version 2 in June 2012 which included additional details for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies. The TMF RM volunteers are beginning the revision process to create version 3. Get involved in ‘Too Much Fun’ by joining the TMF RM group!.
Many of you will have heard of the OASIS eTMF standard for interoperability and will be wondering where this fits with the TMF RM. The answer is they should work together to be a standard for content and for interoperability, without impacting current implementations of the TMF RM. The TMF RM group seeks alignment between the two in order to advance the cause of interoperability for our industry; many TMF RM members provided feedback on the initial draft OASIS specification.
Over the coming months, several new TMF RM deliverables will be released, including:

  • A Usability Guide, to help companies maximize the benefits of adopting the TMF RM
  • A Metrics & Reporting Model, to help companies measure TMF completeness, timeliness, and quality using a common framework
  • A Quality Control Process Model, to help companies improve quality throughout the lifecycle of the TMF

At the DIA EDM meetings in Washington (October) and Berlin (December), there will be dedicated sessions focussed on the EDM and eTMF Models, their usage, how they can be expanded, feedback & experience from users etc. New ideas often spring from these lively discussions – we hope to see you there!
Published by the TMF RM Steering Committee:
Sam Mowaswes, Daiichi Sankyo, Biopharma
Colleen Maude, GSK, Biopharma
Martin Thorley, Pfizer, Biopharma
Karin Schneider, Janssen, Biopharma
Tamika Jackson, Corementum, Consultant
Lisa Mulcahy, Mulcahy Consulting, Consultant
Fran Ross, Paragon, Consultant
Eldin Rammell (Secretary), Rammell Consulting, Consultant
Jamie Toth, Covance, CRO
Steve Scribner (Vice Chairman), EMC, Vendor
Paul Fenton, Montrium, Vendor
Sharon Ames, NextDocs, Vendor
Karen Roy (Chairman), Phlexglobal, Vendor / CRO
Todd Tullis, Veeva, Vendor
How to find out more:
Monthly calls (join our Yahoo! Group)

 

What's Happening with the TMF Reference Model?

You may be wondering what the connection is between the  TMF Reference Model and the Drug Information Association (DIA) and how the Reference Model is managed. The information posted below should help to provide some clarification.
Has the DIA dropped the TMF Reference Model?
No. Following a discussion towards the end of 2012 about the official name for the Reference Model, it was mutually agreed that the term “DIA” should be omitted from the name of the model because the intellectual property rights are not owned by the DIA. The model itself was developed by a large community of industry colleagues, the vast majority of whom were and still are DIA members. However, the model is in the public domain and owned by industry as a whole, so for this reason it cannot be referred to as the “DIA” TMF Reference Model. The DIA have not “dropped” the Reference Model or discontinued any association with the model or the group of colleagues that are part of the TMF Reference Model community.
Has the DIA selected the OASIS eTMF Standard as the preferred standard, rather than the TMF Reference Model?
No. The OASIS standard should be viewed as a technical standard to facilitate exchange of documents, whereas the widely accepted TMF Reference Model is setting the content standard, (e.g. attributes, vocabularies, classification and artifacts etc.). Within the context of the proposed OASIS classification scheme this means that the OASIS-proposed CareLex model is an example of an ”organization specific content type or category” whereas the TMF Reference Model must be the domain specific base model. The DIA have NOT gone on record to support the OASIS eTMF standard, though they were asked to do so.
Has the DIA dropped support for the TMF Reference Model community?
No. The TMF Reference Model is still an active DIA group and exists on the DIA Connex site as part of the Records and Document Management Community. However, because involvement in the group’s activities is not exclusively restricted to DIA members, a decision was taken recently by the TMF Reference Model Steering Committee to use a public collaboration platform (Yahoo! Groups) to communicate with members of the group. All recent documentation pertaining to the group is available in a transparent manner to members via this route. We also use other tools – such as this website and LinkedIn – to communicate to the industry as a whole. The group is still very much affiliated with the DIA. The vast majority of its members are also DIA members but just as the DIA permit non-members to attend DIA conferences and other DIA events, we permit non-DIA members to contribute to the TMF Reference Model as we do not wish DIA membership to be a hindrance to broad industry input.
Does the TMF Reference Model Group have elected leaders and official records?
Yes. Towards the end of 2013, it was proposed that a Steering Committee be formed to help guide the group. An initial group of members was proposed for the Steering Committee comprising primarily of the Zone Leads. Following a communication to the whole group in December 2013, a small number of additional members came forward to join the inaugural Steering Committee to make a group of fourteen. The list of Committee Members and their Charter are available for any member to see on the group’s Yahoo! site. A formal ballot was held to elect Chair, Deputy Chair and Secretary by anonymous, electronic voting. The results of this ballot are on record. The current holder of these three positions are Karen Roy, Steven Scribner and Eldin Rammell. In accordance with the rules of the Charter, as membership on the Steering Committee expires, the vacant positions will be opened up to nomination from any TMF Reference Model member. All records of the Steering Committee and TMF Reference Model team are filed on the Yahoo! site.
So the bottom line is, the TMF Reference Model is still very much alive, is associated with DIA as part of the Records & Document Management Community and is developing exciting plans for the rest of 2014. Keep a watch out for the roadmap…. this will detail plans for the various activities that we aim to undertake over 2014 and 2015!

OASIS eTMF Interoperability Standard – Last Chance to Comment!

As you probably know, the draft eTMF Standard Specification is currently on a 45-day public review cycle. This review window closes on Friday 8th August.
We have been asked by a few people to provide concrete examples of feedback that can be provided. As an example, the vocabulary taxonomy being proposed by the OASIS eTMF Technical Committee includes the following:

  • All trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) are being considered a single artifact/content type.
  • All site-level IRB/IEC documents will be considered different content types to the equivalent trial-level IRB/IEC documents and classified within the Site Management zone rather than the IRB/IEC zone.
  • There is no provision for country-level IRB/IEC documents.
  • An “IRB/IEC-approved” ICF is considered a different artifact to the master ICF submitted to the IRB/IEC. The same applies to subject diaries, questionnaires, information sheets, subject participation cards etc. Approval of a document is more usually considered a property of the document (metadata) rather than changing the content or artifact type.
  • The Site Management zone includes a section specifically for documents that relate to a specified site (“Investigator Documents”). This section contains 39 separate artifacts or content types. Outside of this section are listed other artifacts which are also site-specific i.e. inconsistent classification.

If you have concerns about any of these specific points, please review rows 82 to 152 of the OASIS vocabulary [http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/vocabulary/Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01.xls] and send your comments back to the Technical Committee before the deadline expires on FRIDAY 8TH AUGUST. As a reminder, to send comments to OASIS, please follow the instructions below:
1.       Subscribe to the comment list by sending a blank email message to: etmf-comment-subscribe@lists.oasis-open.org
2.       Confirm your subscription request by replying to the confirmation email message you will receive from OASIS. Your subscription will not be complete until you respond to this message.
3.       Watch your inbox for a Welcome message indicating that your subscription is now active.
4.       Send your comment to: etmf-comment@lists.oasis-open.org
Once this review window closes, there will be no further opportunity to provide comment on this content. Future review cycles will only permit comment on changes since this initial draft.

Collaboration Platform – Help Getting Emails

We’ve been alerted to the fact that some TMF Reference Model team members who have moved across to the new Yahoo! Groups collaboration platform may not be receiving emails and other notifications from the group. This is because Yahoo! creates a Yahoo! email address when a new user establishes a Yahoo! account (e.g. johndoe@yahoo.com) and by default, all emails and notifications get sent to that email address! If this is OK for you, you can set up this email account on your phone, tablet or browser but for most people, they want to receive emails and notification on their regular email account. You have to go into your membership settings to add a new email address if you want to use an email address other than Yahoo! Mail.
This is a really easy task to do but we have created a Quick Guide to help you through the steps. More help is also available from the Yahoo! Groups Help pages online.

New Collaboration Platform for Reference Model Project

The TMF Reference Model Project has grown from a small group of DIA members in 2009 to a team of well over 300 people today from around the globe, covering pharmaceutical companies, biotechnology companies, CROs, vendors, consultants and other interested parties. We have been struggling a little to keep on top of the list of members and have not really had an ideal solution for sharing electronic content that we are working on, other than mailing out to all members as an email attachment….. not great Records Management practice!
The TMF Reference Model Steering Committee were therefore charged with identifying a collaboration platform with the following features:

  • calendar, including sending alerts to members of upcoming events;
  • communication to all members using standard electronic mail;
  • document library with sub-folder capability;
  • no software to download;
  • no cost.

After considering about a dozen possible solutions, we decided upon using Yahoo! Groups and we’re now in the process of getting all members signed up to Yahoo! Groups. Our choice does not provide full document management functionality (e.g. check-in, check-out, version management) but we decided that overall the benefits outweighed the disadvantages. We also recognized that access to the Yahoo! Groups web pages is blocked by some of our member company’s firewall settings. However, this restriction generally does not affect the email communication features of Yahoo! Groups. Therefore, members will still receive communication from the Team but may need to access the file library and other online resources from a personal PC.
If you are an existing member of the TMF Reference Model Project or would like to become an active, participating member of the project, please register to Join the Group at http://bit.ly/tmfrefmodel. If you don’t wish to participate but still have an interest in following what we are doing, just follow this blog and also join the LinkedIn Group.

eTMF Vendor Outreach Initiated

The TMF Reference Model Project have initiated a program to reach out to the eTMF vendor community to get input into a key subject which is generating a lot of discussion at the moment – eTMF interoperability. There was some initial work done on interoperability within the reference model subcommittees and more recently we have seen the launch of an eTMF standard Technical Committee initiative within OASIS. Experience has shown that vendors play a key role in the adoption and implementation of any interoperability standard and we wanted to specifically solicit vendor feedback and thoughts on the best path forward.

 

In our opinion, there are several paths that the vendor community could follow, notably:

 

  • Join the OASIS Technical Committee to participate in the development of the eTMF interoperability standard and then adopt the standard fully or partially once released;
  • Adopt the OASIS standard fully or partially once it is released without participation in the OASIS Technical Committee;
  • Develop a vendor-initiated standard and find a standards body to manage it in collaboration with the TMF Reference model interoperability sub-committee;
  • Take no action and let interoperability evolve naturally; or
  • Other paths that have not yet been explored / proposed 

One thing is clear, as more and more sponsors and CROs adopt eTMF, the need for a standard is becoming indispensable and with vendors being on the front line to implement such a standard, their input is very important. Integration and alignment with the TMF reference model is also key, given the large number of industry players who have already implemented the model.

 

The TMF Reference Model interoperability sub-committee is in the process of organizing an online call with vendors in the coming weeks to discuss the different paths towards interoperability and to gauge their initial thoughts and intentions. This will help guide the work that the interoperability sub-committee will be undertaking to ensure that any interoperability standard is properly aligned with and leverages the TMF Reference Model.

 

If you are an eTMF solution vendor willing to participate in such a discussion or if there is a colleague within your organization who is more appropriate to participate, please get in touch with us to be part of this exciting work.

2014 TMF Survey Ready for Your Input

Please join the fourth industry-wide Trial Master File survey!  Make sure your perspective is heard, and get valuable insights and data for your TMF improvement initiatives.  An outgrowth of the volunteer TMF Reference Model initiative, this survey is designed to provide year-over-year TMF details from sponsors, CROs, inspectors, and sites, for both paper and electronic TMF management.  The intent is to identify TMF trends, assess changes in industry directions, and measure the impact of TMF models.  Our colleagues have already reported the usefulness of the survey data from the three prior survey and we expect this one to be no exception. The Survey link is:  http://www.surveymonkey.com/s/WZHSL2P.
Survey 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 individual is identified in the results.
Please note that this survey is completely independent and is not sponsored by or promoted by any company, vendor or commercial organization. The TMF Survey has been developed by volunteer members of the TMF Reference Model initiative and results are made available free-of-charge to industry. Information about us is found at the end of the survey, and also at:  http://www.diahome.org/en/news-and-publications/publications-and-research/edm-corner.aspx.
 

OASIS eTMF Interoperability Committee Discusses Digital Signatures

oasisThe latest meeting of the OASIS eTMF Interoperability Technical Committee convened yesterday (3rd March). The main topic on the agenda was signatures and how these should be exported from one system to another. A number of interesting – and perhaps controversial – issues were discussed. The meeting began with an overview presentation of some of the regulations pertaining to electronic and digital signatures, one of the key ones highlighted being 21CFR11. The guidance from the FDA suggests that export of records should be in common file formats such as PDF, XML or SGML. The benefits of digital signatures was highlighted by Peter Alterman from SAFE-BioPharma.
We pointed out that whilst digital signatures might be seen as “the gold standard”, 21CFR11, the FDA and EMA all permit the use of simple electronic signatures and these are widely used across industry within eTMF systems currently. It is important therefore that any eTMF interoparbility standard should not exclude this type of signature manifestation. Similarly, the discussion focussed heavily on the EMA and FDA requirements for digital signatures on documents included in submissions but these only make up a small part of TMF component (typically 45 artfacts out of the 245 in the TMF Reference Model).
There was even a question raised regarding what documents needed to be signed. It is clear this is outside the remit of the OASIS Technical Committee! It is for industry to decide what documents to sign – referring to relevant regulations – and to use whatever technology is appropriate to them. The OASIS TC then needs to ensure the standard accommodates common industry practice. In fact, the Committee did recognise that wet-ink signatures are still used widely across industry and the metadata model for interoperability needs to recognise the fact that some scanned images in eTMF systems will bear a wet-ink signature and the related file attributes are important for interoperabilty and data exchange.
On the topic of export format for documents, perhaps the Technical Committee is going ‘off piste’ again? The reference to the FDA guidelines is not referring to export of TMF content from one systen to another. The reference actually relates to the provision of TMF content for inspection purposes. Ideally, the original TMF content would be provided but the guidance note 3.4 from the FDA confirms that export of content using automated means to common file formats such as PDF, XML and SGML is permitted. Surely, when transferring TMF content from one eTMF system to another (i.e. TMF interoperability) the ideal scenario is to retain content in its original format? So if the the source eTMF system creates and maintains records in Microsoft Word, the target eTMF system would accept the content in Microsoft Word, and not in a different file format. This is not to preclude file format conversion but simply to state that an interoperability standard should not dictate the source or target file format.
If you have a view on this topic, or any other topic related to TMF interoperability, please make sure you sign up as an OASIS member and join the Technical Committee.

TMF Reference Model (TMF RM) Steering Committee Statement on the OASIS Interoparability Initiative

The TMF Reference Model Steering Committee (SC) has been discussing eTMF interoperability in the light of recent announcements from OASIS following the establishment of an eTMF Standard Technical Committee within OASIS. Overall, we are supportive of this initiative, but with caveats as detailed below.
The TMF Reference Model provides sponsors and CROs with a reference point to help them define the content of their TMFs with recommended content definition, vocabulary and taxonomy that meets their business needs. We have considered whether the TMF Reference Model should be developed into a standard but there are significant concerns with this proposal, including the need for individual sponsors to retain flexibility in their approach to TMF content management across varying regulatory requirements globally and the absence of a definitive TMF inventory from any regulatory agency. For the time being then, the SC will not be recommending development of the Reference Model as a standard though will review the decision again in the future. This is in line with the survey done at the end of 2013 where although 97% of the respondents felt that an interoperability standard was needed, 34% of respondents felt that the TMF Reference Model itself should not be a standard. However, we confirm that industry is facing significant difficulties arising from the inability of eTMF solutions to easily exchange content with each other. In this respect, we agree that a globally recognized interoperability standard would be helpful. This should be an open source technical standard that facilitates the exchange of TMF content between eTMF systems whilst allowing a dynamic content definition, taxonomy and vocabulary.
With respect to the OASIS initiative, we have significant concerns that the TMF Reference Model is not being used as the starting material for the OASIS Technical Committee. We do not support the use of the CareLex Reference Model taxonomy and vocabulary as the starting material for the interoperability standard. We are also concerned that the activities of the OASIS Technical Committee should not be unfairly biased towards any one vendor, CRO or organization. In addition, the development of a standard with an organization that is more closely aligned with Life Sciences/Healthcare may have been more appropriate. However, we firmly believe that the initiative within OASIS provides an acceptable opportunity for the clinical community – including sponsors, CROs, vendors, sites and other interested parties – to develop a technical interoperability standard and we therefore support development of such a standard via the OASIS Technical Committee.
We believe that a usable and valuable eTMF interoperability standard would be consistent and harmonized with the TMF Reference Model and we acknowledge that the Model may require changes in the course of developing the interoperability standard. For this reason, we believe it is important for our TMF Reference Model community to be appropriately represented on the OASIS Technical Committee. As an organization, we are unable to provide official representatives for the Technical Committee but we encourage individuals to join the OASIS Technical Committee as employees of the companies they work for, particularly those who have experience and technical expertise in the management of electronic TMF documents and/or data exchange systems.
If your company is already an OASIS member, you may obtain an OASIS login and once you have a login you then join the eTMF Standard TC. If your company is not yet an OASIS member and there are multiple people who wish to participate, your company will need to join OASIS ($3,520 – $8,825, depending in the size of your company) and then each individual obtain an OASIS login and then join the eTMF TC. If you are the only employee likely to participate in your company, you may join OASIS with individual/associate membership ($1,315). Finally, if you are unemployed or a self-employed consultant, you may join as an individual ($325).
The public web page of the OASIS eTMF Standard Technical Committee can be found here.
Karen Redding (Chair), Steve Scribner (Vice-chair), Eldin Rammell (Secretary)