>> Jon McKeeby: My name is Jon McKeeby.
I'm the clinical information officer of the Clinical Center
of the National Institutes of Health.
Today, we'll talk about the Clinical
Data Interchange Standards Consortium, CDISC.
We will first discuss the basics.
From the principles and practice of clinical research book,
CDISC is reviewed as the standards for clinical research.
Standards exist for organizing clinical research data
to enable sharing and aggregation.
CDISC was created as a standard
for submitting regulatory information to the FDA.
CDISC with FDA, HL7,
NCI combined efforts with the Biomedical Research
Integrated Domain Group, BRIDG, to operationalize CDISC.
CDISC is a standards development organization
whose focus is medical research data linked with healthcare.
It is to enable information system interoperability
to improve medical research and related areas of healthcare.
The mission of CDISC is to develop
and support global platform independent data standards,
to improve medical research and related areas of healthcare.
It is to ensure interoperability between research and healthcare.
It is to streamline the workflow from EHRs clinicians
who conduct research.
The benefits are reduced time to set up research,
traceability from the EHR
to the clinical research database,
improve data quality, improve data sharing
and interoperability across research organizations,
reduce costs for setup and overhead of data analysis
for the length of study, and increase predictability
by creating repeatable and streamlined process.
In another conversation,
we talked about common data elements.
CDISC provides standards, common data elements,
in a common data model.
CDISC importance is research studies can be initiated faster.
Gartner reported in 2007
that it reduced setup time by 70 to 90 percent.
It also allows research studies
to significantly have fewer resources,
both in time and personnel.
It ensures the data quality and integrity
that's higher than without having standards.
It improves communication across the teams for research,
across organizations, across stakeholders.
It ensures data sharing and interoperability
between systems and organizations.
And it provides high quality reporting to the FDA,
clinicaltrials.gov, and other regulatory organizations.
The guiding principles of CDISC are to develop standards
of the highest quality to allow all researchers
to leverage and share information from individuals
and studies around the world.
To facilitate the ability for implementers
to effectively structure and analyze data
so it's easily interpreted, understood,
and navigated by regulatory reviewers;
ensure the standards are developed in a manner
that emphasize content, structure, and quality,
transcending implementation strategy and platform;
provide a global, multidisciplinary
cross-functional community of members,
volunteers, and stakeholders
from across the research spectrum
to develop consensus-based standards;
collaborate and partner
with fellow thought leaders and organizations
on key initiatives to foster efforts
to advance standards and semantics;
and accomplish this without promoting
any individual vendor or organization.
Create a set of standards that is agnostic to any vendor.
There's been many milestones.
It started in 1997 as a volunteer group.
It then became more formal in 2000.
Created as an independent nonprofit organization.
Global participation started in 2001.
And then the various standards have been created
over time from 2001 to current.
This is just a list of the major standards
that were created by CDISC.
In 2017, there was a paper that was created
to review the importance of data standards in clinical research.
And they identified the importance
to promote interoperability.
And in the paper, they specifically mentioned CDISC.
And you should use data standards that are common,
known and accepted.
And that the data standards from CDISC
should be considered as the best starting point
for defining and coding data
and metadata in a consistent way.
They identified that CDISC is an operational data model
that provides a good starting point.
It provides metadata that provides one mechanism
to remove ambiguity.
And then it has the advantage of ensuring data traceability
and providence of data through the research process.
Ways CDISC is used. It's an exchange format.
It's used to exchange data utilizing XML format.
We see that in its use to provide protocol data
to clinicaltrials.gov as well as pharmaceutical data to the FDA.
CDISC provides a controlled terminology
common data elements.
They create a common set of terms across therapeutic areas.
And then as a reference model, a physical database.
It's used as a common data model to establish semantic and syntax
to share with stakeholders across studies.