Implementation of CDISC Standards

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Implementation of CDISC Standards

• Presented By
• Sandeep (Raj) Juneja, ASG Inc., Cary, NC

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AGENDA

• CDISC Introduction
• CDISC Implementation Application.
• Open Discussion

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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 its a finding)

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SDS V3 Standard Data Structures
Interventions
Events
Findings
IE
AE
EX
LB
DS
CM
VS
SC
SU
MH
PE
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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SNAPSHOT AE.sas Template
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SNAPSHOT AE.sas Template
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Validating CDISC Datasets

• PROC CDISC MODELSDTM
• SDTM SDTMVersion "3.1"
• DOMAINDATA DATA results.AE
• DOMAIN AE
• CATEGORY
  EVENTS
• RUN

• CDISC Procedure Capabilities
• Domain content of the source
• Verifies that all required variables are present
  in the data set
• Reports as an error any variables in the data set
  that are not defined in the domain Reports a
  warning for any expected domain variables that
  are not in the data set Notes any permitted
  domain variables that are not in the data set
• Verifies that all domain variables are of the
  expected data type and proper length Detects any
  domain variables that are assigned a controlled
  terminology specification by the domain and do
  not have a format assigned to them.
• 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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Open 4 Discussion