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>> Jon McKeeby:
My name is Jon McKeeby.

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I'm the clinical information
officer of the Clinical Center

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of the National
Institutes of Health.

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Today, we'll talk
about the Clinical

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Data Interchange Standards
Consortium, CDISC.

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We will first
discuss the basics.

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From the principles and practice
of clinical research book,

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CDISC is reviewed as the
standards for clinical research.

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Standards exist for organizing
clinical research data

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to enable sharing
and aggregation.

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CDISC was created
as a standard

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for submitting regulatory
information to the FDA.

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CDISC with FDA, HL7,

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NCI combined efforts with
the Biomedical Research

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Integrated Domain Group, BRIDG,
to operationalize CDISC.

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CDISC is a standards
development organization

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whose focus is medical research
data linked with healthcare.

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It is to enable information
system interoperability

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to improve medical research and
related areas of healthcare.

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The mission of
CDISC is to develop

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and support global platform
independent data standards,

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to improve medical research
and related areas of healthcare.

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It is to ensure interoperability
between research and healthcare.

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It is to streamline the
workflow from EHRs clinicians

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who conduct research.

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The benefits are reduced
time to set up research,

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traceability
from the EHR

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to the clinical
research database,

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improve data quality,
improve data sharing

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and interoperability across
research organizations,

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reduce costs for setup and
overhead of data analysis

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for the length of study,
and increase predictability

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by creating repeatable
and streamlined process.

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In another conversation,

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we talked about
common data elements.

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CDISC provides standards,
common data elements,

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in a common data model.

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CDISC importance is research
studies can be initiated faster.

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Gartner reported in 2007

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that it reduced setup
time by 70 to 90 percent.

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It also allows
research studies

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to significantly have
fewer resources,

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both in time and personnel.

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It ensures the data
quality and integrity

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that's higher than
without having standards.

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It improves communication
across the teams for research,

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across organizations,
across stakeholders.

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It ensures data sharing
and interoperability

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between systems
and organizations.

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And it provides high quality
reporting to the FDA,

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clinicaltrials.gov, and other
regulatory organizations.

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The guiding principles of
CDISC are to develop standards

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of the highest quality
to allow all researchers

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to leverage and share
information from individuals

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and studies around the world.

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To facilitate the ability
for implementers

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to effectively structure
and analyze data

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so it's easily
interpreted, understood,

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and navigated by
regulatory reviewers;

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ensure the standards are
developed in a manner

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that emphasize content,
structure, and quality,

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transcending implementation
strategy and platform;

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provide a global,
multidisciplinary

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cross-functional
community of members,

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volunteers, and stakeholders

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from across the
research spectrum

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to develop
consensus-based standards;

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collaborate and partner

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with fellow thought leaders
and organizations

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on key initiatives
to foster efforts

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to advance standards
and semantics;

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and accomplish this
without promoting

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any individual vendor
or organization.

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Create a set of standards
that is agnostic to any vendor.

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There's been many milestones.

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It started in 1997
as a volunteer group.

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It then became more
formal in 2000.

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Created as an independent
nonprofit organization.

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Global participation
started in 2001.

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And then the various
standards have been created

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over time from
2001 to current.

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This is just a list
of the major standards

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that were created by CDISC.

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In 2017, there was a paper
that was created

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to review the importance of data
standards in clinical research.

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And they identified
the importance

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to promote interoperability.

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And in the paper, they
specifically mentioned CDISC.

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And you should use data
standards that are common,

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known and accepted.

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And that the data
standards from CDISC

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should be considered as
the best starting point

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for defining
and coding data

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and metadata in a
consistent way.

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They identified that CDISC
is an operational data model

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that provides a good
starting point.

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It provides metadata that
provides one mechanism

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to remove ambiguity.

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And then it has the advantage
of ensuring data traceability

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and providence of data
through the research process.

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Ways CDISC is used.
It's an exchange format.

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It's used to exchange data
utilizing XML format.

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We see that in its use
to provide protocol data

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to clinicaltrials.gov as well as
pharmaceutical data to the FDA.

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CDISC provides a
controlled terminology

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common data elements.

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They create a common set of
terms across therapeutic areas.

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And then as a reference model,
a physical database.

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It's used as a common data model
to establish semantic and syntax

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to share with stakeholders
across studies.