How to improve quality control in a data conversion process?

By extended usage of metadata!

Dimitri Kutsenko Entimo AG - Berlin/Germany

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 219-Oct-2010

Data Conversion ProcessSDTM Example

SOURCE TARGETALGORITHMS

PROCESS

CHECKS

Generic view

Core process

Define Dataset

Structure

Annotate CRF

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 319-Oct-2010

Cost of Change Curve

Early QC Paradigm

QC Tasks

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 419-Oct-2010

Maintain Standards Library

Invest effort into standards definition! Metadata Types

Dataset descriptions (industry or company domains)

Conversion algorithms (text and code) Mappings Terminology…

Challenges Global, project, trial and study levels Multiple standards / versions Interlinked dimensions Reusability

Analysis of cross-level and cross-study dependencies required!

Maintain Standards Library

Define Dataset Structure

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define.xml

Annotate CRF

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 519-Oct-2010

Standards Metadata Profiling

4646 11 1.771.77 24.524.5

4444 00 1.621.62 30.230.2

4646 00 1.661.66 33.133.1

6262 11 1.801.80 21.921.9

AE Domain (Global)

AE Domain (Study)

Compare metadata domain definitions

Detect and review discrepancies as early as possible!

Metadata MetadataData Profiling

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 619-Oct-2010

StandardsImpact Analysis

Common (Global)

AE Domain (Study)

AE Dataset

Track deviations between (changed) standards and related targets!

Analysis/update shall include impact on datasets linked to standards

Versioning/audit trail required for updates

Metadata Metadata Data

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 719-Oct-2010

Define MetametadataDefine Dataset Structures

Define “Metametadata” (description of dataset metadata): Columns Formats to support checks Configuration rules for metadata Rule examples:

CDISC type – character, mandatoryseq – integer, unique, starts with 1

Define Dataset Structures: Use metadata domain templates Derive from datasets, metametadata

Maintain Standards Library

Define Dataset Structure

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define.xml

Annotate CRF

Define Metametadata

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 819-Oct-2010

Define Mapping

Challenges: Repeated algorithms Scarce experts Redundancy

Exploit standards at maximum! Standard metadata (domains) Standard conversion algorithms Standard mappings

Quality checks in the mapping definition: Consistency checks Review can be done

language-independent

Maintain Standards Library

Define Dataset Structure

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define.xml

Create aCRF

Define Metametadata

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 919-Oct-2010

Perform SDTM Checks

Integrate checks into conversion workflow! (incl. tracing)

Flexible definition of check criteria required: Standard SDTM conformance checks Customer checks

Checks from the 1st domain on!Executable

ProgramMapping Program

Source Data Source Checks SDTM Data

Target Checks

Check Report

Check Report

Maintain Standards Library

Define Dataset Structure

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define.xml

Create aCRF

Define Metametadata

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 1019-Oct-2010

Metadata driven, template based definition

Check of data vs. metadata prior to: Import/production Define creation

Generate DefineStructural Checks

Mapping Specs

Mapping Programs

TARGET METADATA

Target DataDefine(xml)

Conservative Process

Metadata Driven Process

Mapping Specs

Define(xml)

Mapping Programs

TARGET METADATA

Target Data

Structure Check

Maintain Standards Library

Define Dataset Structure

Define Mapping

Generate and Run Mapping Program

Perform SDTM Checks

Generate Define.xml

Create aCRF

Define Metametadata

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 1119-Oct-2010

Metadata Challenges

Model related challenges: Metadata variation vs. metadata “inflation” Interlinked dimensions Automatic collection and processing

Organization related challenges: Effort for standard development Consistent metadata management Model independence Different business processes Regulatory requirements

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 1219-Oct-2010

Metadata Based Data Conversion Process

Metadata QC leveraged by smart tools/systems help you: Increase data quality and consistency Reduce cost of errors Flexibly support available and future standards Increase reusability of process components Set up controlled and traceable process

© Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 1319-Oct-2010

END

Many thanks for your attention!Questions…?

Visit at entimo’s booth or email to dku[at]entimo.de

VISION STARTS NOW!