END TO END SDTM AUTOMATION A METADATA CENTRIC APPROACH

Roman RadelickiTeam Manager Data Programming

PhUSE US Connect 2019, February 25th

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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INTRODUCTION

n What is the key to creating clinical databases that are compliant with CDISC SDTM standards?§ Metadata driven approach§ Seamless integration of processes and people

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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MDR – METADATA REPOSITORY

n Master source of metadata containing multiple metadata libraries.

SGS IG v5.0 CLIENT X IG v1.0

CLIENT Y IG v1.0

CLIENT Z IG v3.2

CLIENT Y IG v2.0

CLIENT Z IG v3.3

MDR

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MDR – METADATA REPOSITORY

n Structure based on the Define-XML model

n Contains all available domains, variables, valuelists, codelists, comments and computational methods

Domains

Variables

Value lists

Code lists

Comments

Methods

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MDR – METADATA REPOSITORY

n 3 types of MDR libraries

• Maintained by SGS • Dictated by the client• Maintained together

with the client

• Maintained by the Client

• Implemented by SGS

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MDR – METADATA REPOSITORY

Client A – Trial A

SGS IG v5.0

CLIENT X IG v1.0

CLIENT Y IG v1.0

CLIENT Z IG v3.2

CLIENT Y IG v2.0

CLIENT Z IG v3.3

MDR

SGS IG v5.0Client B – Trial B

SGS IG v5.0

Client Y – Trial Y

CLIENT Y IG v2.0

Trials

Client B – Trial C

SGS IG v5.0

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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MDR DRIVEN TOOLS

Client A – Trial A

SGS IG v5.0

CLIENT X IG v1.0

CLIENT Y IG v1.0

CLIENT Z IG v3.2

CLIENT Y IG v2.0

CLIENT Z IG v3.3

MDR

SGS IG v5.0Client B – Trial B

SGS IG v5.0

Client Y – Trial Y

CLIENT Y IG v2.0

Trials

Annotation Tool

MDR Driven Tools

Mapping Tool

Metadata Center

YADLi Define.xml

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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ANNOTATION TOOL

n How we used to annotate a CRF

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ANNOTATION TOOL

n Font: Courier vs Arial

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ANNOTATION TOOL

n Size: 11 vs 18

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ANNOTATION TOOL

n Color

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ANNOTATION TOOL

n Domain missing

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ANNOTATION TOOL

n Annotation properties

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ANNOTATION TOOL

n Domain colors

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ANNOTATION TOOL

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ANNOTATION TOOL

n Driven by the MDR

n Guide the user in generating annotations

n Provide automatic layout consistency

n Provide automatic adherence to client specifications

n The more the tool is used, the smarter it gets

Annotation Tool

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ANNOTATION TOOL

n Annotation type§ Annotation templates§ Guide the user § Configurable per MDR

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ANNOTATION TOOL

n Annotation type demo§ Weight of a subject § TESTCD

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ANNOTATION TOOL

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ANNOTATION TOOL

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ANNOTATION TOOL

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ANNOTATION TOOL

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ANNOTATION TOOL

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ANNOTATION TOOL

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ANNOTATION TOOL

n Tracking review process§ Statuses§ Multiple users at the same time

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ANNOTATION TOOL

n Advantages§ More accurate and better quality aCRF§ Annotations stored/available in database

• Use in other processes: SDTM mapping, define.xml

§ Maintenace of MDR• Request for new values in valuelist/codelist (MDR)

§ Future proof: Plug & play MDR

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ANNOTATION TOOL

n Challenges§ Screen vs exported PDF file

n Opportunities§ Further automatisation: auto copy annotations from the

library or previously annotated CRF’s

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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SDTM MAPPING TOOL

n Transform EDC source data to SDTM

n Guide the programmer in performing the mapping

n High flexibility

n High quality CDISC SDTM datasets

Mapping Tool

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SDTM MAPPING TOOL

n Transform EDC source data to SDTM

n Guide the programmer in performing the mapping

n High flexibility

n High quality CDISC SDTM datasets

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SDTM MAPPING TOOL

n To learn more about our pre-conversionPieter Blomme: paper DH03

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SDTM MAPPING TOOL

n

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SDTM MAPPING TOOL

n All input fields, radio buttons and checkboxespresented like a pivot table

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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METADATA CENTER

n Automate setup of trial specific metadata

n Start: copy the complete MDR libraryprogrammer will make the metadata trial specific

Metadata Center

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METADATA CENTER

n Automate setup of trial specific metadata

n Start: copy the complete MDR libraryprogrammer will make the metadata trial specific

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METADATA CENTER

n Automate setup of trial specific metadata

n Start: copy the complete MDR libraryprogrammer will make the metadata trial specific

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METADATA CENTER

n Automation § Use the information collected via other in-house

developed applications§ Annotation tool

• SGSSTATE flag • ORIGIN• CRF pages

§ SDTM mapping tool• Calculate the maximum length of the variables in the

SDTM datasets

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METADATA CENTER

n Metadata checks§ Addition to Pinnacle21 validation§ Validate metadata integrity and compliance with the

specific MDR library

n Audit trail§ Record every manipulation of metadata on trial level

• What was manipulated + Old value• Person perfomed the manipulation• When it was manipulated

§ Produce reports• All manipulations performed from a specific date• Retrieve metadata as it was on a specific date

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METADATA CENTER

n Opportunities§ Past: creation of metadata late in the process of

creating SDTM datasets

§ Now: move the creation of the metadata to the front of the process

• Pave the path for future tasks

• Discuss and agree upon metadata with the client upfront

• In line with define.xml purpose

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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YADLI

n YADLi = Yet Another Data Loader improved§ Load any kind of source data§ Perform data manipulations

YADLi

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YADLI

n DTA – Data Transfer Agreementagree on format and structure

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YADLI

n YADLi loads the file into the database

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YADLI

n Programmer maps the data to SDTM

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YADLI

n YADLi produces output that can be used in SDTM datasets

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YADLI

n Best features§ Handles any type of format§ Logging and traceability

n Challenge§ Load any kind of format and structure

n Opportunity§ Further integration into the SDTM mapping tool

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OVERVIEW

n Introduction

n MDR – metadata repository

n MDR driven tools§ Annotation Tool § SDTM Mapping Tool § Metadata Center§ YADLi

n Conclusion

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CONCLUSION

n MDR to automate SDTM workflows paid off

n Road hasn’t been easy

n Work in progress

Thank you for your attention!

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