Implementation of CDISC Standards

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

AGENDA
CDISC Introduction CDISC Implementation Application. Open Discussion

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)

SDS V3 Standard Data Structures

Interventions EX CM SU

Events
AE DS MH

Findings LB IE SC

Other Special Purpose Domains Trial Design

VS
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.

CDISC Implementation Application (CApp)

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.

SNAPSHOT: SETUP Sheet

SNAPSHOT: INDEX Sheet

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 SDTM DOMAINDATA MODEL=SDTM; SDTMVersion = "3.1"; DATA = results.AE DOMAIN = AE CATEGORY = EVENTS; RUN;

Supported SDTM 3.1 Domains

DOMAIN=

CATEGORY=

Demography
Comments Concomitant Medications Exposure Substance Use Adverse Events Disposition Medical History ECG Test Results Inclusion/Exclusion Exception Laboratory Test Results Physical Examinations Questionnaires Subject Characteristics Vital Signs

DM
CO CM EX SU AE DS MH EG IE LB PE QS SC VS

Special
Special Interventions Interventions Interventions Events Events Events Findings Findings Findings Findings Findings Findings Findings

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

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