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>> Jon McKeeby: Common Data
Elements, Part 2 of 4.

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Again, my name is
Jon Walter McKeeby.

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I'm the chief
information officer

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at the Clinical
Center of the NIH.

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And we utilize
common data elements

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to share data across
clinical research.

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So, this is the second
part of the series.

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So, we're going
to review NIH

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Data Management
and Sharing Policy.

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Under the Data Management
and Sharing Policy,

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NIH expects that investigators
and institutes plan and budget

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for the management
and sharing of data.

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All researchers need to
submit a data management

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sharing plan for review
when applying for funding.

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Comply with the approved
data management sharing plan.

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Individual NIH
Institute Centers

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and Offices may have additional
policies and expectations,

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and we identify a link
for those policies.

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CDEs can be a part of a
compliant data management

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and sharing plan.

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They should be. They allow
the sharing to occur.

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Using Common data elements can
be part of an effective plan

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for managing and sharing data.
According to the policy,

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NIH encourages researchers
to use common data elements

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in order to improve
accuracy, consistency,

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and interoperability among
data sets within various areas

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of health and disease research.

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We provided links here on Office
of Intramural Research Guidance,

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as well as Office of
Intramural Data Management

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and Sharing Plan Template.

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They state that
researchers must describe

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what Common data elements
will be used in their project

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and to justify if common data
elements will not be used.

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Common data element
usage at NIH.

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Some institutes and
centers have had mature

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common data element
programs for years.

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Examples are the
clinical center, BTRIS,

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which is the repository
for the intramural program

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at the NIH of all the
clinical research data.

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And then NINDS has
common data elements

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across domains of
different diseases.

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And we'll talk about that.

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NLM has been involved with
common data element since 2012.

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NLM encourages the adoption of
common data elements across NIH.

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There's an NIH common
data element taskforce,

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and there's an NIH common
data elements repository.

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And we'll review all these items
in the next set of slides.

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So BTRIS is the NIH
Intramural Research Program

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research clinical
data warehouse.

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We've had data since 1976
in different databases,

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different systems,
in our original EHR,

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which was referred to as MIS,
our original laboratory system.

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And so, we have all this data
and we want to utilize it.

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So, we developed a
terminology to allow this.

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So, the BTRIS common data
element is referred to as RED,

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the Research Entity Dictionary.

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BTRIS allows bidirectional
exchange of data

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between clinical and
I.C. research systems.

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Medical record number
is the key identifier

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to identify a patient.

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We have self-service as well
as assisted data curation,

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and we facilitate data exchange
with research collaborators.

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We provide data from BTRIS
to multiple clinical systems

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utilizing the common
data elements

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that are specific to our
research entities dictionary.

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And so BTRIS, we have
multiple systems that feed

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our data repository
referred to as BTRIS.

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We provide the data
through extractions,

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our self-service as
well as we produce

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reports specific to request.

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And so, this is the services
that BTRIS provides.

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BTRIS is based on the
research entities dictionary

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referred to as RED.

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It allows ensure operability
across NIHIC systems.

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Allows multiple classifications
and hierarchies to coexist.

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And it allows tests to
be defined across years,

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names, type of test. And so,
a glucose ordered in MIS

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if it's following the
same reference range,

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following the same instruments,
glucose and CRIS --

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which is our
current HER --

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various types of
ordering the glucose

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would be all identified
as the same test.

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Below is the RED web search.

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So, you can search for specific
items and know the values.

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And by clicking it,
then you can find values

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across the entire repository
that fit that item.

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So, this is an example
of common data

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elements specific for
NIH Intramural Program.