1. CDISC2RDF
• CDISC2RDF started as a cross-pharma pre-
competitive project with AstraZeneca, Roche,
W3C et al. to show case Semantic Web
standards and Linked Data principles.
• Now part of the Semantic Technology
project, in the FDA/PhUSE working group
for Emerging Technologies, with 30+
representatives from FDA, CDISC,
pharma:s, CRO:s and software vendors.
• And also, connected to the convergence
now happening across six research projects
targeting Semantic Interoperability for
Clinical Research & Patient Safety
(EU IMI and FP7 projects)

2. CDISC2RDF
Human readable documentation in
PDF:s, Excel:s (and some in XML)
“Text strings”
URI:s (Uniform Resource Identifiers)
as “phone-numbers” for each part in
the standards: variables, domains,
code lists, classifiers etc.
http://rdf.cdisc.org/sdtm-1-2/schema#Classifier.RecordQualifier
http://rdf.cdisc.org/sdtmig-3-1-2/std#Column.AE.AEACN
http://rdf.cdisc.org/sdtm/ct#C66767.C49505
Machine processable linked
data structured as RDF triples
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CDISC2RDF Schemas
Serializations of RDF triples
in XML, Turtle, JSON, CSV …
Based on the core ISO11179 model
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools
“Record Qualifier “
“AEACN“
“DOSE REDUCED” for “Action taken with Study Treatment”
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3. Examples
• Record Qualifier (SDTM Model 1.2 )
• AE Action Taken variable (SDTM IG 3.1.2)
• Term “DOSE REDUCED” for “Action taken
with Study Treatment” (SDTM CT)
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RDF triples: Subject Predicate Object

4. SDTM IG
3.1.22
CDISC2RDF Schemas
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools
SDTM
1.2 Model
SDTM
CT
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5. SDTM IG
3.1.2
SDTM
1.2 Model
SDTM
CT
RDF triples representing one variable/data element
and also linked to related standard parts
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Serializations of RDF triples
in XML, Turtle, JSON, CSV …
CDISC2RDF Schemas
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools

6. SDTM IG
3.1.2
SDTM
1.2 Model
SDTM
CT
RDF triples representing one variable/data element
linked to related standard parts
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Serializations of RDF triples
in XML, Turtle, JSON, CSV …
CDISC2RDF Schemas
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools

7. RDF triples representing one Classifier of variables/
data elements defined in other parts of the standard
SDTM
Model 1.21
SDTM IG
3.1.22
Serializations of RDF triples
in XML, Turtle, JSON, CSV …
CDISC2RDF Schemas
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools

8. RDF triples representing one term for one controlled
term list being used in other parts of the standard
SDTM
CT3
SDTM IG
3.1.2
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Serializations of RDF triples
in XML, Turtle, JSON, CSV …
CDISC2RDF Schemas
Being used to annotate the existing Excel files
to transform to RDF using off-the-shelf tools