TMF Reference Model Training Part 1

TMF Reference Model
20 Jun 202208:31

Summary

TLDRThe video introduces the Trial Master File (TMF) Reference Model, highlighting its evolution from a need for standardized essential trial documents to its current status as a de facto standard in the industry. Co-founders Karen Roy and Lisa Mulcahy led its development, which has now become part of the CDISC standards organization. The model is governed by a steering committee and a change control board, with a community of members contributing to its ongoing development and maintenance.

Takeaways

  • 📚 The Trial Master File (TMF) is a collection of essential documents that tell the story of a clinical trial, allowing for its verification and quality assessment.
  • 🌐 The TMF Reference Model is a standardized structure, content, and naming convention for these essential documents, aiming to streamline the clinical trial process.
  • 🎉 As of 2019, 83% of respondents in a survey reported using the TMF Reference Model, highlighting its widespread adoption as a de facto standard.
  • 🚀 Originating from the Document and Records Management Community of the DIA, the TMF Reference Model was developed to address gaps in existing regulatory document frameworks.
  • 🔍 The initial version of the TMF Reference Model focused on the minimum list of essential documents as outlined by ICH E6, but expanded to include additional records and areas such as data management and statistics.
  • 🤝 The development of the TMF Reference Model involved a collaborative effort, recruiting contributors from various conferences to pool knowledge and structures.
  • 🌟 The first version of the TMF Reference Model was released in 2010, with subsequent versions incorporating regulatory feedback and additional components.
  • 📈 Between 2011 and 2013, the model evolved to include investigative site files, devices, process-based metadata, and it became more formal with the establishment of a steering committee.
  • 🔄 The Exchange Mechanism Specification was introduced to facilitate the interoperable transfer of documents between systems, enhancing the functionality of the TMF Reference Model.
  • 🔄 In 2022, the TMF Reference Model became part of the CDISC standards organization, further solidifying its role in the clinical trial community.
  • 💡 The TMF Reference Model is governed by a formal charter with a 14-member steering committee and a change control board, ensuring a balanced representation from various stakeholders.

Q & A

  • What is a Trial Master File (TMF)?

    -A Trial Master File (TMF) is a collection of essential documents that tell the story of a clinical trial, allowing for the verification of how the trial was conducted and the quality of the data generated.

  • What does the TMF Reference Model standardize?

    -The TMF Reference Model standardizes the structure, contents, and naming conventions of the essential documents within a Trial Master File.

  • According to the 2019 survey, what percentage of respondents were using the TMF Reference Model?

    -In the 2019 survey, 83 percent of respondents indicated that they were currently using the TMF Reference Model.

  • How did the TMF Reference Model originate?

    -The TMF Reference Model originated from the Document and Records Management Community within the丁香园 (DIA), which was tasked with creating the Electronic Document Management Reference Model (EDM RM) focused on regulatory documents.

  • What was the motivation behind creating a specific reference model for the TMF?

    -The motivation behind creating a specific reference model for the TMF was the realization that existing guidelines such as ICH E6 did not provide a comprehensive list of essential documents, particularly lacking in data management, statistics, imaging, electronic systems, and safety sections.

  • How was the initial version of the TMF Reference Model developed?

    -The initial version of the TMF Reference Model was developed by recruiting a diverse group of contributors who shared their knowledge and TMF structures, resulting in a comprehensive set of artifacts that formed the basis of the model.

  • When was the first version of the TMF Reference Model released?

    -The first version of the TMF Reference Model was released in 2010.

  • What significant changes were made between 2011 and 2013 in the TMF Reference Model?

    -Between 2011 and 2013, the TMF Reference Model incorporated Investigative Site Files, Devices, Process-Based Metadata, and began various work groups. It also transitioned from being under the DIA to becoming its own entity.

  • How has the TMF Reference Model evolved in terms of formal governance?

    -The TMF Reference Model evolved by establishing a steering committee in 2014 to govern the model, creating a change control board, and releasing the Exchange Mechanism Specification to facilitate document transfer and interoperability.

  • What is the current status of the TMF Reference Model in 2022?

    -As of 2022, the TMF Reference Model has become part of the Clinical Data Interchange Standards Consortium (CDISC), a standards organization, and continues to be developed with extensive information available on its website.

  • How is the TMF Reference Model community structured and governed?

    -The TMF Reference Model community is structured with a 14-member steering committee, an active member community of 333 individuals, a subscription group of 4,000 people, and a LinkedIn community group. The steering committee is voted in by the community members and serves three-year terms.

  • How can one get involved with the TMF Reference Model community?

    -To get involved with the TMF Reference Model community, one can visit the TMF Reference Model website at www.tmfrefmodel.com/join to register and participate in various initiatives, work groups, and forums.

Outlines

00:00

📚 Introduction to the TMF Reference Model

This paragraph introduces the two-part series on the TMF (Trial Master File) Reference Model, with Karen Roy, one of the co-founders and the current chair of the steering committee, also serving as the Chief Strategy Officer at Flex Global. The focus of this part is on the history and status of the TMF Reference Model, emphasizing its importance as a standardized structure for essential documents relating to clinical trials. It highlights the widespread adoption of the TMF Reference Model, as evidenced by the 83% usage rate reported in a 2019 survey. The origins of the TMF Reference Model are traced back to the DIA (Document and Records Management) community, which led to the creation of the EDM (Electronic Document Management) Reference Model. The evolution towards a TMF-specific model is explained, detailing the gaps in the ICH E6 guidelines and the collaborative effort in developing the first version of the TMF Reference Model in 2010. The involvement of regulatory bodies like MHRA and FDA and the subsequent updates to the model are also discussed, culminating in the formal establishment of a steering committee and change control board, and the release of the Exchange Mechanism Specification.

05:00

🌐 Management and Future of the TMF Reference Model

This paragraph delves into the management structure and future developments of the TMF Reference Model. It discusses the formal governance under a charter, with a 14-member steering committee and a change control board. The steering committee's composition is highlighted, including a mix of sponsor companies, vendors, and consultants, with an emphasis on avoiding dominance by any single group. The community's role in the model's evolution is underscored, with active members, a subscription group, and a LinkedIn community. The paragraph also touches on the resources available on the TMF Reference Model website, including forums for communication and upcoming meetings. The paragraph concludes with an invitation for involvement and feedback, directing interested parties to the website for registration and engagement. Additionally, the paragraph announces the TMF Reference Model's integration into the CDISC (Clinical Data Interchange Standards Consortium) organization, signaling its growing recognition and importance in the industry.

Mindmap

Keywords

💡Trial Master File (TMF)

A Trial Master File (TMF) is a collection of essential documents that narrate the story of a clinical trial, allowing for the verification of how the trial was conducted and the quality of the data generated. It is a critical component in clinical research, ensuring regulatory compliance and data integrity. In the video, the speaker explains that the TMF consists of documents that cover the entire lifecycle of a clinical trial, from planning to archiving, and is essential for regulatory authorities to review the conduct of the trial.

💡TMF Reference Model

The TMF Reference Model is a standardized framework that defines the structure, content, and naming conventions for the documents within a Trial Master File. It serves as a guideline for organizing and managing clinical trial information, thereby facilitating a more efficient and consistent approach to trial documentation. The video explains that the TMF Reference Model has become a de facto standard in the industry, with 83 percent of respondents in a 2019 survey reporting its usage.

💡History

The history of the TMF Reference Model is traced back to its origins within the Document and Records Management Community of the DIA (Drug Information Association). The model evolved from the need to standardize the management of regulatory documents to encompassing a broader range of trial-related documents. The video outlines the development process, from its initial conception to its current status as part of the CDISC (Clinical Data Interchange Standards Consortium), a standards organization.

💡Standardization

Standardization in the context of the TMF Reference Model refers to the process of creating uniform structures, content requirements, and naming conventions for clinical trial documents. This helps ensure consistency across trials, simplifies the management and exchange of information, and aids in regulatory compliance. The video emphasizes the importance of standardization in making the TMF a more effective tool for managing clinical trial data.

💡Regulatory Documents

Regulatory documents are those required by regulatory authorities to ensure the safety, efficacy, and quality of clinical trials. These documents are a crucial part of the Trial Master File and must be meticulously managed and maintained. In the video, the speaker mentions that the initial focus was on regulatory documents, but the scope was expanded to include other trial-related documents, reflecting the comprehensive nature of the TMF Reference Model.

💡ICH E6

ICH E6, or the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guideline, provides a minimum list of essential documents for a Trial Master File. It serves as a guideline for the organization and content of clinical trial data. The video explains that ICH E6 was found to be insufficient in covering all necessary documents, particularly in areas like data management and statistics, leading to the development of the TMF Reference Model.

💡Community

The community in the context of the TMF Reference Model refers to the group of individuals and organizations that contribute to the development, maintenance, and usage of the model. This includes sponsors, vendors, consultants, and other stakeholders who work together to ensure the model's relevance and effectiveness. The video emphasizes the collaborative nature of the community and its role in shaping the TMF Reference Model.

💡Steering Committee

The Steering Committee is the governing body responsible for overseeing the TMF Reference Model. It ensures that the model remains relevant and up-to-date with the changing needs of the clinical trial industry. The video explains that the committee is composed of representatives from various stakeholder groups and operates under a formal charter, with members serving three-year terms.

💡Change Control Board

The Change Control Board is a group within the TMF Reference Model community that manages updates and changes to the model. It ensures that any modifications are carefully considered and approved, maintaining the integrity and consistency of the TMF Reference Model. The video highlights the importance of this board in the governance structure of the model.

💡Exchange Mechanism Specification

The Exchange Mechanism Specification is a set of guidelines within the TMF Reference Model that facilitates the transfer of documents between different systems. It supports interoperability, allowing for seamless data exchange and communication between various electronic systems used in clinical trials. The video explains that this mechanism is a significant component of the TMF Reference Model, enhancing its utility in the modern clinical trial landscape.

💡CDISC

The Clinical Data Interchange Standards Consortium (CDISC) is a global, non-profit organization that develops and maintains standards for the acquisition, submission, and archiving of clinical research data. In the video, it is mentioned that the TMF Reference Model has become part of CDISC, indicating its integration into a broader set of standards that aim to improve the quality and efficiency of clinical research.

💡Feedback

Feedback in the context of the TMF Reference Model is the input and suggestions provided by users and stakeholders to improve and refine the model. It is a crucial part of the model's ongoing development and maintenance process. The video encourages viewers to submit their feedback through the TMF Reference Model website, emphasizing the importance of community involvement in shaping the model.

Highlights

Introduction to the TMF Reference Model by Karen Roy, one of its co-founders.

The TMF Reference Model is a standardized structure, contents, and naming conventions for essential documents in a clinical trial.

In a 2019 survey, 83% of 247 respondents reported using the TMF Reference Model, indicating its widespread adoption.

The origin of the TMF Reference Model is traced back to the DIA (Document and Record Management) community's efforts.

The initial development of the TMF Reference Model involved combining the ICH minimum document list with additional trial records.

The first version of the TMF Reference Model was released in 2010, with regulatory feedback incorporated in the 1.1 version released in 2011.

Between 2011 and 2013, the TMF Reference Model expanded to include investigative site files, devices, process-based metadata, and began work groups.

In 2014, the TMF Reference Model became more formal with the establishment of a steering committee and change control board.

The Exchange Mechanism Specification was released to facilitate the interoperable transfer of documents between systems.

Version 3 of the TMF Reference Model was released, and by 2022, it had become part of the CDISC (Clinical Data Interchange Standards Consortium).

The TMF Reference Model is governed under a formal charter with a 14-member steering committee and a change control board.

The steering committee is elected by the community members and serves three-year terms, ensuring diversity and rotation.

The TMF Reference Model community consists of an active member community, a subscription group, and a LinkedIn community with thousands of members.

The TMF Reference Model website (www.tmfrefmodel.com) offers extensive resources, forums, and a feedback mechanism for users.

The TMF Reference Model's development and management involve a collaborative effort from various stakeholders, including sponsors, vendors, and consultants.

The TMF Reference Model has evolved to address gaps in existing regulatory document requirements, such as ICH E6 and FDA regulations.

The TMF Reference Model's future developments and updates are guided by community input and regulatory advancements.

Transcripts

play00:03

welcome to part one of two-part series

play00:06

on training of the tmf on the tmf

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reference model my name is karen roy i

play00:12

am one of the co-founders of the tmf

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reference model i currently chair the

play00:15

steering committee and i'm also chief

play00:17

strategy officer at flex global

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today's training is really going to

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focus on the history and the status of

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the tmf reference model part two will

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focus on the content of the tmf

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reference model and really dive into the

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detail of how it's structured

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before we start talking about the

play00:39

history of the model i thought it was

play00:41

worthwhile to just do a very quick recap

play00:45

on what is a trial master file so

play00:48

essentially a trial master file consists

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of what's known as essential documents

play00:53

relating to that trial it's a collection

play00:56

of documents it tells the story of the

play00:58

trial to allow verification of how the

play01:00

trial was conducted and the quality that

play01:03

was used to generate the data

play01:05

so what is a tmf reference model

play01:08

a standardized

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structure contents and naming of these

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essential documents

play01:14

it might be interesting for you to know

play01:16

that

play01:17

in the survey in 2019 247 respondents

play01:22

83 percent of people said they were

play01:24

currently using the tmf reference model

play01:26

so really it has become a bit of a de

play01:29

facto standard

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where did the tmf reference model come

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from

play01:34

well it actually came out of the dia

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there was a community in the dia called

play01:38

the documents and records management

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community

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they were tasked to create what is known

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as the edm reference model electronic

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document management reference model

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really focused on the regulatory

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documents

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but during this process it was realized

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that a number of these documents are

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actually tms documents so my co-founder

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and i lisa mulcahy and i were approached

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to come up with

play02:03

a list of these tmf documents

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this actually evolved into us actually

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needing a tmf reference model so you

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might say well why did we need a

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reference model well we started at ica

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g6 section 8.2 to 8.8 where it lists the

play02:19

minimum

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list of document of essential documents

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for

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a tmf

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it's not the comprehensive list and when

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we started digging into it we realized

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that actually ich e6 was very very light

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it didn't have a lot of documents that

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were relevant uh data management and

play02:36

stats area were very missing all the new

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ways of all the different ways of

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testing all the different imaging

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electronic systems

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the safety section was very light and so

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what we decided that was that what

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really we needed to try and pull

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together a specific reference model for

play02:54

the tmf

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now we were limited in terms of what we

play02:59

were looking at so we really took the

play03:01

ich minimum list

play03:03

and then we said okay

play03:05

we are looking from a tmf reference

play03:07

model perspective at that minimum list

play03:09

plus all the other trial records that

play03:12

specifically permit the evaluation the

play03:14

conduct for trial and the quality of the

play03:16

data produced so what did we do

play03:19

well we went out and we recruited a lot

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of people uh we every conference we went

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to we pulled people in

play03:26

and

play03:27

when

play03:28

in 2009

play03:30

we started this recruitment process our

play03:33

initial meeting was then and we

play03:35

basically tried to pull the knowledge

play03:38

from all the different contributors

play03:40

everyone contributed their own tmf

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structures everybody contributed their

play03:45

own knowledge and we pulled and got a

play03:47

super set of what we called ended up

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calling artifacts and this will all be

play03:51

covered off in

play03:53

section two of the training and we

play03:55

released our first version in 2010

play03:58

we then got the regulators specifically

play04:01

mhra and fda to have a look at this

play04:03

and

play04:05

we included our regulator feedback in

play04:07

version 1.1

play04:09

released in 2011.

play04:12

between 2011 and 2013 we included

play04:16

investigative site files devices

play04:18

process-based metadata and we started a

play04:20

load of work groups and in that time we

play04:22

also separated from the dia we have

play04:25

always been supported by the dia but as

play04:27

we had a product

play04:28

it could not be owned by the dia so we

play04:30

are actually the tmf reference model not

play04:33

the dia tmf reference model

play04:36

in 2014 we felt that it was time to

play04:38

become a bit more formal and we

play04:40

established a steering committee

play04:42

which was going to govern the tmf

play04:44

reference model we established a change

play04:46

control board and between 2014 and 2021

play04:51

we also released what is known as the

play04:52

exchange mechanism specification and

play04:55

there's a lot of

play04:56

information available on the tmf

play04:58

reference model website about this

play05:00

essentially it's a way of transferring

play05:03

documents from one system to another in

play05:06

this smooth it it supports

play05:07

interoperability

play05:09

we also released version 3 of the

play05:10

reference model

play05:12

we're now in 2022 and we're very excited

play05:15

to say that tmf reference model has

play05:17

become part of cdisc a standards

play05:20

organization and again there is a lot of

play05:22

information available on our website to

play05:25

talk about the move to cdisc and to give

play05:27

you some further information there

play05:31

so how is it managed it's governed under

play05:34

a formal charter we have a 14 member

play05:36

steering committee we have a chair

play05:38

currently myself a secretary we have a

play05:41

charter which is available on our

play05:42

website as you can see we have the

play05:44

website there www.tmfrefmodel.com

play05:48

with a lot of resources and we also have

play05:50

a change control board

play05:53

the steering committee today consists of

play05:56

these people as you can tell

play05:58

there's a mixture of sponsor companies

play06:01

of cos of vendors there's consultants if

play06:05

we try and have a wide range and in fact

play06:08

our charter insists that no one group

play06:11

can dominate

play06:12

the the steering committee the steering

play06:14

committee are voted in by the members of

play06:17

the tmf reference model community

play06:19

and they serve three-year terms and

play06:22

rotate every three years

play06:26

so the community that i just mentioned

play06:28

first of all there's the steering

play06:30

committee the steering committee of 14

play06:32

then there's an active member community

play06:35

which is currently 333 people these are

play06:38

the volunteers the people that actually

play06:40

work on the zone groups work on the

play06:42

change control board work on

play06:46

the different initiatives then we have a

play06:48

subscription group who are notified of

play06:50

what's going on almost a mailing list um

play06:52

and that's four thousand people so what

play06:55

sixteen hundred people the four thousand

play06:57

is the linkedin community um and that's

play06:59

so there's a linkedin community group as

play07:01

well so that is how all the different

play07:03

community parts of the community and if

play07:05

you want to get involved go to our

play07:06

website

play07:08

httpmodel.com forward slash join

play07:13

this is a community with many many

play07:15

deliverables if you go onto the website

play07:16

you will see there's all these different

play07:19

areas where you can get useful

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information where you can ask lots of

play07:22

questions there's forums a wonderful way

play07:25

of communicating with the reference

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model and this is just a screenshot of

play07:29

of the reference model website where you

play07:31

can see our upcoming meetings and where

play07:34

you can

play07:35

find out in information that you want to

play07:37

do do you want to get that you want to

play07:39

know

play07:41

if you have any feedback on the

play07:42

reference model again you go to the

play07:44

website you go to feedback and that's

play07:46

where you can submit your feedback

play07:51

so

play07:52

if you want to have get to get involved

play07:55

join register tmf reference model

play07:57

website

play07:58

if you want to give feedback you can

play08:00

join and give the feedback there

play08:02

and hopefully this has given you a

play08:04

little bit of a very brief introduction

play08:06

to the reference model how it came about

play08:09

where it is today

play08:10

listen to part two to hear about the

play08:13

actual model itself how it's structured

play08:16

and how you can use the reference model

play08:19

thank you very much

play08:30

you

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Related Tags
ClinicalTrialsTMFHistoryStandardizationRegulatoryComplianceIndustryAdoptionCommunityDrivenFlexGlobalCDISCIntegrationInteroperabilityChangeManagement