Improving CDISC SDTM Data Quality & Compliance Right from the … · 2017-10-08 · Background • SDTM (Study Data Tabulation Model) • Beneficial for clinical data reviewers &

Improving CDISC SDTM Data Quality & Compliance

Right from the Beginning

Bharat Chaudhary, CytelPadamsimh Balekundri, Cytel

Session CD08 – PhUSE 2015, Vienna

Agenda

• Background

• Overview: SDTM Development

• The Problem: In SDTM Development

• Our Solution: Set of Utilities

• Summary

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Background

• SDTM (Study Data Tabulation Model)

• Beneficial for clinical data reviewers & analysts as it brings standardization in presenting the data

• Complexity of standards - Risk of compliance issue – Rework

• Validation tools & Techniques - Limitations

• Scope for Improvement – Ideas

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Overview: SDTM Development

aCRFSDTM

Specification SDTM Programdevelopment

SDTM datasets

OpenCDISCValidator

CDMS Data SDTM

independentvalidation

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REWORK

The Problem: In SDTM development

aCRFSDTM


SDTM datasets

OpenCDISCValidator

CDMS Data SDTM


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Solution

aCRFSDTM


SDTMdatasets

OpenCDISCValidator

CDMS Data SDTM


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What can be done?

REWORK

12

3

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Steps to go throughRework Area

Solution

Utility

With & Without

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Solution 1

Solution 1

aCRFSDTM


SDTMdatasets

OpenCDISCValidator

CDMS Data SDTM


ü We might miss the basics while creating the SDTM spec (specification)

ü End up creating multiple versions of spec

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Rework Area

Solution 1

SDTM Spec Checker

ü Identify compliance issues at spec level, even before programming

ü Minimize the number of spec versions, which saves time & efforts

(SSC)

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Solution

Solution 1

SingleWindowView

Technology: MS ExcelInputs: SDTM SpecExecution Time: < 1 Min

(SSC)Framework

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UtilitySDTM IG

Standards

ImportedMetadata

from SDTM spec

Result

COMPARE

Solution 1

1. SDTM Mapping specification open/active

(SSC)Execution Step

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2. SDTM Spec Checker

Utility

Solution 1(SSC)

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Utility

Solution 1(SSC)

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Utility

Solution 1(SSC)

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Utility

Solution 1(SSC)Final Report

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Utility

Solution 1(SSC)Final Report

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Utility

Solution 1

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Average time taken to review the SDTM Specification with 10 domains.

3-4Hrs

<20Min

(SSC)

With & Without

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Solution 2

Solution 2

aCRFSDTM


SDTM datasets

OpenCDISCValidator

CDMS Data SDTM


ü SDTM compliance & Data consistency errors are not identified

ü End up doing multiple validation cycles

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Rework Area

Solution 2

SDTM Dataset Checker

ü Identify data quality and SDTM compliance issues at development stage

ü Minimize the number of validation cycle, which saves time & efforts

(SDC)

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Solution

Solution 2Framework

Technology: SAS MacroInputs: SDTM SAS DatasetExecution Time: < 5 Min

(SDC)

SDC Utility

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SDTM datasets

Utility

Solution 2(SDC)Framework

ü Having inbuilt checks

ü First these checks will apply on the Domain

Master Macro

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Utility


ü It’s a reference file

ü Having metadata of commonly used CDISC SDTM IG versions

CDISC Master file

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Utility


ü Having Checks in this excel fileü User can add any number of custom checks

SDTM Checks file

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Utility


ü User-defined checks

ü If user wants to add any complex algorithm

Study Specific macro

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Utility

Solution 2(SDC)Execution Step

§ To apply on all domains in sdtm library :

%sdtm_chk (sdtm_v=3.1.2, lib= sdtm);

§ To apply on specific domain (i.e. LB) :

%sdtm_chk (sdtm_v=3.1.2, lib= sdtm, check=lb );

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Utility

Solution 2(SDC)Final Report

ü Easy navigation & filtering can be applied for better understanding of issues

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Utility

Solution 2(SDC)Real Life Example

§ Date of early visit > Date of later visit

§ Duplicate records

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§ Unexpected Results

Utility

Solution 2(SDC)Real Life Example

§ Non missing –-ORRES & –-ORRESU but --STRESC is blank

§ Incorrect order of variables, USUBJID before DOMAIN

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Utility

Solution 2

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Average time taken to review the SDTM SAS Dataset with 1 domain.

2-3Hrs

<25Min

(SDC)

With & Without

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Solution 3

Solution 3

aCRFSDTM


SDTM datasets

OpenCDISCValidator

CDMS Data SDTM


ü Repeat runs of OpenCDISC validator for same study

ü Possibility of missing to identify new issues each time we run the validator

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Rework Area

Solution 3

ü It saves time on multiple report reviews for the same study, by

(OCR)

• Importing and aligning comments from previous/first report

• Identifying new errors/warnings

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OpenCDISC Report Reviewer

Solution

Solution 3Framework

Technology: MSExcel-VBAMacroInputs: ReviewedOpenCDISCReportExecution Time: < 2 min

(OCR)

Reviewed Report OCR Utility New Summarized Report

Importing Comments

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Utility

Solution 3(OCR)Execution Step

ü First reviewed OpenCDISC Report

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ü New reportUtility

Solution 3(OCR)Execution Step

ü Utility will import comments from previous report and align them with new report

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ü Filter out ‘New Errors’ and address it, Instead of reviewing entire report

Utility

Solution 3(OCR)

ü The OCR utility also generates the summary report

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Final Report

Utility

Solution 3

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Average time taken to review new errors in OpenCDISC Reports.

2-3Hrs

<2Min

(OCR)

With & Without

SSC

REWORK

aCRFSDTM


SDTM datasets

OpenCDISCValidator

CDMS Data SDTM


Summary

SDC

OCR

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Questions ?

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Thank you !!

[email protected]@cytel.com

Improving CDISC SDTM Data Quality & Compliance Right from the … · 2017-10-08 · Background • SDTM (Study Data Tabulation Model) • Beneficial for clinical data reviewers &

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