Main title slide header - Lex Jansen

Main title slide header - Lex Jansen

PATTERNS EMERGING FROM CHAOS 6th June 2018, PhUSE US Connect, Raleigh Alan Cantrell 2018 PAREXEL INTERNATIONAL CORP. AGENDA Introduction Historical changes to structure Metadata Linkage Metadata changes and impact Governance and patterns Conclusion 2018 PAREXEL INTERNATIONAL CORP. / 2

INTRODUCTION (HUB) AE Domain Definition Pattern Coded Item Other Action Concept ACNOTH Taken DATA IS MAPPED TO AND FROM A HUB . ON E I AT M SL YNA N A A TR ISPL D P. E OU AM GR AYN

PL DIS CDASH / Data Collection Other Action AEACNOTH Taken DISP LAY NAM E (SPOKES) ISO 21090 BASED CLINICAL RECOGNIZABLE CONCEPTS USABLE FOR CDISC AND OTHER DATA MODELS SDTM / Data Tabulation Other Action AEACNOTH Taken

ADaM / Data Analysis AEACNOTH Other Action Taken AEACNOFL Other Action Taken Flag Mapping by declaration to concepts Allows End to End (E2E) data flow dry-run without data Study teams worry about the what not the how 2018 PAREXEL INTERNATIONAL CORP. / 3 HISTORICAL CHANGES TO STRUCTURE - I Source Metadata Specification Target

Metadata A specification documents the requirements and rules for mapping from source to a target The specification is dependent on the source and target metadata. If either changes the specification needs to be adapted it acts as a bridge Source metadata could be updated by a protocol amendment or change in expectations by sponsor 2018 PAREXEL INTERNATIONAL CORP. / 4 HISTORICAL CHANGES TO STRUCTURE - II Source Metadata Specification

Target Metadata Example Protocol Version 1 Adverse Event Start Date collected in format ddmmmyyyy, e.g. 06JUN2018 Protocol Amendment 1 Adverse Event Start Time is added to the data collection instrument, e.g. 14:00 and Adverse Event Start Date collection format is changed to yyyymmdd, e.g. 20180606 2018 PAREXEL INTERNATIONAL CORP. / 5 METADATA LINKAGE - I PATTERNDATEITEM ITEM.DDMMMYYYY TIME.HHMM A pattern defines the structure of

attributes with a common theme Each pattern has an associated SAS macro developed to allow the attributes to be understood when called ITEM.YYYYMMDDHHMM ITEM.YYYYMMDD 2018 PAREXEL INTERNATIONAL CORP. / 6 StartDate Code METADATA LINKAGE - II PATTERNDATEITEM The associated pattern code facilitates the reading in of variable metadata and outputting of variable

metadata ITEM.DDMMMYYYY ITEM.IMPUTEFIRST.FLAG In turn the pattern code when called enables the generation of code to implement this transformation using the data ITEM.IMPUTEFIRST.SAS ITEM.YYYYMMDD StartDate Code * Date variables; %gmPatternDateItem( varsIn = aeStDtC = item.yyyymmdd , varsOut = aStDt = item.imputeFirst.sas @ aStDtF = item.imputeFirst.flag , codeOut = startDateCode); 2018 PAREXEL INTERNATIONAL CORP. /

7 METADATA CHANGES AND IMPACT - I ADVERSE EVENTS DOMAIN DEFINITION STDTC StartDateCode DCI ADVERSE EVENTS SDTM AE ADAM ADAE AESTDTC AESTDTC AESTDTC

ASTDTC ASTDT ASTDTF START DATE START TIME StartDate Code 2018 PAREXEL INTERNATIONAL CORP. / 8 METADATA CHANGES AND IMPACT - II Pre-protocol amendment Changing the format of the source metadata retains the connectivity between the data collection instrument and SDTM but updates the related source code

2018 PAREXEL INTERNATIONAL CORP. / 9 Post-protocol amendment METADATA CHANGES AND IMPACT - III In addition, a change to the Statistical Analysis Plan could impact the method for imputing the analysis date and flags such as ASTDT / ASTDTF 2018 PAREXEL INTERNATIONAL CORP. / 10 GOVERNANCE AND PATTERNS - I Metadata is stored within the MDR and is version controlled

Updated metadata is used to generate updated mapping code Code related to metadata is retained using subversion StartDate StartDate Code StartDate Code Code 2018 PAREXEL INTERNATIONAL CORP. / During the pattern code execution; checks are performed on the metadata; the data and that the metadata is consistent between the study instance metadata; metadata in pattern code generated 11 GOVERNANCE AND PATTERNS - II

By developing and releasing pattern definitions in a controlled environment we ensure Consistency across projects and programs Increase efficiency as patterns are reusable in multiple places Patterns have the ability to evolve with the changing landscape if additional attributes are required these can be added The additional attributes and new patterns are managed centrally to ensure SME guidance is followed 2018 PAREXEL INTERNATIONAL CORP. / 12 CONCLUSION Using patterns to connect form items, SDTM and ADaM variables to a central hub ensures changes to metadata allow connectivity to remain in place.

Patterns emerging from chaos QUALITY 2018 PAREXEL INTERNATIONAL CORP. / CONSISTENCY 13 EFFICIENCY QUESTIONS For more information: Alan Cantrell Associate Director, Statistical Programming [email protected]XEL.com Come and see us at PAREXELs booth! Visit our MDR resource portal at: https://www.parexel.com/solutions/cl inical-research/global-data-operation s/clinical-metadata-repository-mdr

2018 PAREXEL INTERNATIONAL CORP. / 14 THANK YOU 2018 PAREXEL INTERNATIONAL CORP. / 15

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