TMF Reference Model Training Part 1

Summary

The 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.

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

welcome to part one of two-part series

on training of the tmf on the tmf

reference model my name is karen roy i

am one of the co-founders of the tmf

reference model i currently chair the

steering committee and i'm also chief

strategy officer at flex global

today's training is really going to

focus on the history and the status of

the tmf reference model part two will

focus on the content of the tmf

reference model and really dive into the

detail of how it's structured

before we start talking about the

history of the model i thought it was

worthwhile to just do a very quick recap

on what is a trial master file so

essentially a trial master file consists

of what's known as essential documents

relating to that trial it's a collection

of documents it tells the story of the

trial to allow verification of how the

trial was conducted and the quality that

was used to generate the data

so what is a tmf reference model

a standardized

structure contents and naming of these

essential documents

it might be interesting for you to know

that

in the survey in 2019 247 respondents

83 percent of people said they were

currently using the tmf reference model

so really it has become a bit of a de

facto standard

where did the tmf reference model come

from

well it actually came out of the dia

there was a community in the dia called

the documents and records management

community

they were tasked to create what is known

as the edm reference model electronic

document management reference model

really focused on the regulatory

documents

but during this process it was realized

that a number of these documents are

actually tms documents so my co-founder

and i lisa mulcahy and i were approached

to come up with

a list of these tmf documents

this actually evolved into us actually

needing a tmf reference model so you

might say well why did we need a

reference model well we started at ica

g6 section 8.2 to 8.8 where it lists the

minimum

list of document of essential documents

for

a tmf

it's not the comprehensive list and when

we started digging into it we realized

that actually ich e6 was very very light

it didn't have a lot of documents that

were relevant uh data management and

stats area were very missing all the new

ways of all the different ways of

testing all the different imaging

electronic systems

the safety section was very light and so

what we decided that was that what

really we needed to try and pull

together a specific reference model for

the tmf

now we were limited in terms of what we

were looking at so we really took the

ich minimum list

and then we said okay

we are looking from a tmf reference

model perspective at that minimum list

plus all the other trial records that

specifically permit the evaluation the

conduct for trial and the quality of the

data produced so what did we do

well we went out and we recruited a lot

of people uh we every conference we went

to we pulled people in

and

when

in 2009

we started this recruitment process our

initial meeting was then and we

basically tried to pull the knowledge

from all the different contributors

everyone contributed their own tmf

structures everybody contributed their

own knowledge and we pulled and got a

super set of what we called ended up

calling artifacts and this will all be

covered off in

section two of the training and we

released our first version in 2010

we then got the regulators specifically

mhra and fda to have a look at this

and

we included our regulator feedback in

version 1.1

released in 2011.

between 2011 and 2013 we included

investigative site files devices

process-based metadata and we started a

load of work groups and in that time we

also separated from the dia we have

always been supported by the dia but as

we had a product

it could not be owned by the dia so we

are actually the tmf reference model not

the dia tmf reference model

in 2014 we felt that it was time to

become a bit more formal and we

established a steering committee

which was going to govern the tmf

reference model we established a change

control board and between 2014 and 2021

we also released what is known as the

exchange mechanism specification and

there's a lot of

information available on the tmf

reference model website about this

essentially it's a way of transferring

documents from one system to another in

this smooth it it supports

interoperability

we also released version 3 of the

reference model

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

to say that tmf reference model has

become part of cdisc a standards

organization and again there is a lot of

information available on our website to

talk about the move to cdisc and to give

you some further information there

so how is it managed it's governed under

a formal charter we have a 14 member

steering committee we have a chair

currently myself a secretary we have a

charter which is available on our

website as you can see we have the

website there www.tmfrefmodel.com

with a lot of resources and we also have

a change control board

the steering committee today consists of

these people as you can tell

there's a mixture of sponsor companies

of cos of vendors there's consultants if

we try and have a wide range and in fact

our charter insists that no one group

can dominate

the the steering committee the steering

committee are voted in by the members of

the tmf reference model community

and they serve three-year terms and

rotate every three years

so the community that i just mentioned

first of all there's the steering

committee the steering committee of 14

then there's an active member community

which is currently 333 people these are

the volunteers the people that actually

work on the zone groups work on the

change control board work on

the different initiatives then we have a

subscription group who are notified of

what's going on almost a mailing list um

and that's four thousand people so what

sixteen hundred people the four thousand

is the linkedin community um and that's

so there's a linkedin community group as

well so that is how all the different

community parts of the community and if

you want to get involved go to our

website

httpmodel.com forward slash join

this is a community with many many

deliverables if you go onto the website

you will see there's all these different

areas where you can get useful

information where you can ask lots of

questions there's forums a wonderful way

of communicating with the reference

model and this is just a screenshot of

of the reference model website where you

can see our upcoming meetings and where

you can

find out in information that you want to

do do you want to get that you want to

know

if you have any feedback on the

reference model again you go to the

website you go to feedback and that's

where you can submit your feedback

so

if you want to have get to get involved

join register tmf reference model

website

if you want to give feedback you can

join and give the feedback there

and hopefully this has given you a

little bit of a very brief introduction

to the reference model how it came about

where it is today

listen to part two to hear about the

actual model itself how it's structured

and how you can use the reference model

thank you very much

you