TMF Reference Model Training Part 1
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
📚 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.
🌐 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)
💡TMF Reference Model
💡History
💡Standardization
💡Regulatory Documents
💡ICH E6
💡Community
💡Steering Committee
💡Change Control Board
💡Exchange Mechanism Specification
💡CDISC
💡Feedback
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
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