Cdisc: CDISC (Clinical Data Interchange Standards Consortium)

CDISC
CDISC (Clinical Data Interchange Standards

Consortium)
operates to advance the continued improvement of public
health by enabling eﬃciencies in medical research and
related areas of healthcare.
As a catalyst for productive collaboration, CDISC brings
together individuals spanning the healthcare continuum
to develop global, open,
consensus-based medical research data standards
www.cdisc.org
CDISC GOALS
Nearly seamless exchange of data within a company,
between collaborating companies, and with regulatory
agencies – across protocols, companies and compounds
Effortless archiving of data and metadata for future
review or regulatory audit
Integration of data from a wide variety of applications
and systems
Facilitated reviews of regulatory submissions
Improvements in data quality; ‘cleaner data faster’
Implementation of
CDISC Standards
Study Data Information Model
 3 main types of observations (data domains)
– Interventions, events, findings, and “other”
 Interventions
– Are related to the therapeutic and experimental treatments (expanded
to include other ‘things’)
 Events
– Observations from subjects on adverse reactions
 Findings
– Evaluations/examinations to address specific questions (when in
doubt it’s a finding)
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SDS V3 Standard Data Structures
Interventions Events Findings Other
IE Special Purp
EX AE LB
Domains
Trial
CM DS VS SC
Design
SU MH PE Relationship
Datasets
EG
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Core Variables: Definition
 A required variable is any variable that is basic to the identification of a
data record (i.e., essential key identifiers and a topic variable that cannot
be null)
 An expected variable is any variable necessary to make a record
meaningful in the context of a specific domain (variable should be
included); Some values may be null
 Permissible variables should be used as appropriate when collected or
derived.
 Any general timing variable not explicitly mentioned in a domain model is
permissible to be included
 Only qualifier variables specified in a domain model are allowed for that
domain.
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CDISC Implementation Application
(CApp)
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CApp: Key Issues
Get Raw Dataset(s) Variable(s) information
automatically for CDISC Variable Mapping
Create .sas template for each CDISC dataset
Validate CDISC dataset structure
Keep CApp and .sas templates Synchronized to
automate the Mapping document generation.
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SNAPSHOT: SETUP Sheet
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SNAPSHOT: INDEX Sheet
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SNAPSHOT: AE Sheet
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SNAPSHOT: Raw Variable(s) Information.
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SNAPSHOT: CDISC Menu Option:- Create SAS Program
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SNAPSHOT: AE.sas Template
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Validating CDISC Datasets Supported SDTM 3.1 Domains DOMAIN= CATEGORY=
Demography DM Special
PROC CDISC MODEL=SDTM; Comments CO Special
SDTM SDTMVersion = "3.1";
DOMAINDATA DATA = results.AE Concomitant Medications CM Interventions
DOMAIN = AE Exposure EX Interventions
CATEGORY = EVENTS;
RUN; Substance Use SU Interventions
CDISC Procedure Capabilities Adverse Events AE Events

Domain content of the source: Disposition DS Events
•Verifies that all required variables are present in the data set Medical History MH Events
•Reports as an error any variables in the data set that are not
ECG Test Results EG Findings
defined in the domain Reports a warning for any expected
domain variables that are not in the data set Notes any Inclusion/Exclusion Exception IE Findings
permitted domain variables that are not in the data set Laboratory Test Results LB Findings
•Verifies that all domain variables are of the expected data type
Physical Examinations PE Findings
and proper length Detects any domain variables that are
Questionnaires QS Findings
assigned a controlled terminology specification by the domain
and do not have a format assigned to them. Subject Characteristics SC Findings
Vital Signs VS Findings
The procedure also performs the following checks on
domain data content of the source on a per observation
basis:
•Verifies that all required variable fields do not contain missing
values
•Detects occurrences of expected variable fields that contain
missing values
•Detects the conformance of all ISO-8601 specification
assigned values; including date, time, datetime, duration, and
interval types
•Notes correctness of yes/no and yes/no/null responses,
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Sync.doc: To Synchronize Specs and Template program(s).
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CDISC

CDISC (Clinical Data Interchange Standards

CDISC Procedure Capabilities Adverse Events AE Events

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