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CDISC ADaM 2.1 Implementation: A Challenging Next Step in the Process

CDISC ADaM 2.1 Implementation: A Challenging Next Step in the Process. Presented by Tineke Callant 2014-03-14. Agenda. CDISC - Introduction CDISC - Foundational standards CDISC ADaM V2.1 - Analysis data flow CDISC ADaM V2.1 - ADaM data structures CDISC ADaM V2.1 - Traceability

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CDISC ADaM 2.1 Implementation: A Challenging Next Step in the Process

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  1. CDISC ADaM 2.1 Implementation:A Challenging Next Step in the Process Presented by Tineke Callant 2014-03-14

  2. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  3. Clinical Data Interchange Standards Consortium - Introduction • 1997 - Inception • 2000 - 32 global companies CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. • 2014 - ± 200 organizations • biotechnology and pharmaceutical development companies • device and diagnostic companies • CROs and technology providers • government institutions, academic research centers and other non-profit organizations

  4. Clinical Data Interchange Standards Consortium - Introduction

  5. Clinical Data Interchange Standards Consortium - Introduction • Mission statement The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  Data standards to improve clinical research

  6. Clinical Data Interchange Standards Consortium - Introduction - 2001: Biomedical Research Integrated Domain Group (BRIDG) Model

  7. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  8. CDISC - Foundational standards

  9. CDISC - Foundational standards content transport

  10. CDISC - Foundational standards

  11. CDISC - Foundational standards • Study Data Tabulation Model (SDTM) The content standard for regulatory submission of case report form data tabulations from clinical research studies. Datasets containing data collected during the study and organized by clinical domain. • Analysis Data Model (ADaM) The content standard for regulatory submission of analysis datasets and associated files. Datasets used for statistical analysis and reporting by the sponsor, submitted in addition to the SDTM domains.

  12. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  13. CDISC ADaM V2.1 - Analysis data flow ADaM

  14. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  15. CDISC ADaM V2.1 - ADaM data structures • The Subject-Level Analysis Dataset (ADSL) structure • The Basic Data Structure (BDS) • Other

  16. CDISC ADaM V2.1 - ADaM data structuresThe Subject-Level Analysis Dataset (ADSL) structure • One record per subject • Variables (required + other) • Study identifiers (e.g. DM.STUDYID) • Subject demographics (e.g. DM.AGE) • Population indicator(s) (e.g. RANDFL) • Treatment variables (e.g. DM.ARM) • Trial dates (e.g. RANDDT) • Required in a CDISC-based submission

  17. CDISC ADaM V2.1 - ADaM data structures • The Subject-Level Analysis Dataset (ADSL) structure • The Basic Data Structure (BDS) • Other

  18. CDISC ADaM V2.1 - ADaM data structuresThe Basic Data Structure (BDS) • One or more records per subject, per analysis parameter, per analysis time point (conditionally required) • Variables • e.g. PARAM and related variables • e.g. AVAL and AVALC and related variables • e.g. the subject identification • e.g. DTYPE • e.g. treatment variables, covariates • Supports the majority of statistical analyses

  19. CDISC ADaM V2.1 - ADaM data structures • The Subject-Level Analysis Dataset (ADSL) structure • The Basic Data Structure (BDS) • Other

  20. CDISC ADaM V2.1 - ADaM data structuresOther • CDISC ADaM Basic Data Structure for Time-to-Event Analysis Version 1.0 - May 8, 2012 • CDISC ADaM Data Structure for Adverse Event Analysis Version 1.0 - May 10, 2012

  21. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  22. CDISC ADaM V2.1 - Analysis data flow ADaM

  23. CDISC ADaM V2.1 - Traceability • Understanding the relationship of element vs. predecessor • Enabling transparancy • Analysis results → Analysis datasets → SDTM

  24. CDISC ADaM V2.1 - TraceabilityStrategies for implementing SDTM and ADaM standardsSusan Kenny – Michael Litzsinger • Parallel method SDTM DomainsDBMS Extract Analysis Datasets • Retrospective method DBMS Extract → Analysis Datasets → SDTM Domains • Linear method DBMS Extract → SDTM Domains → Analysis Datasets • Hybrid method DBMS Extract → SDTM Draft Domains → Analysis Datasets → SDTM Final Domains

  25. CDISC ADaM V2.1 - Traceability • Traceability

  26. CDISC ADaM V2.1 - Traceability CDISC ADaM V2.1 Fundamental principles Provide traceability between the analysis data and its source data Practical considerations Maintain the values and attributes of SDTM variables CDISC ADaM implementation guide (IG) V1.0 General variable naming conventions

  27. CDISC ADaM V2.1 - TraceabilityGeneral variable naming conventions Any ADaM variable whose name is the same as an SDTM variable must be a copy of the SDTM variable, and its label, meaning, and values must not be modified

  28. CDISC ADaM V2.1 - TraceabilityStrategies for implementing SDTM and ADaM standardsSusan Kenny – Michael Litzsinger • Parallel method SDTM DomainsDBMS Extract Analysis Datasets • Retrospective method DBMS Extract → Analysis Datasets → SDTM Domains • Linear method DBMS Extract → SDTM Domains → Analysis Datasets • Hybrid method DBMS Extract → SDTM Draft Domains → Analysis Datasets → SDTM Final Domains

  29. CDISC ADaM V2.1 - TraceabilityStrategies for implementing SDTM and ADaM standardsSusan Kenny – Michael Litzsinger • Linear method DBMS Extract → SDTM Domains → Analysis Datasets • Traceability • CDISC SDTM/ADaM Pilot Project • Recommended

  30. CDISC ADaM V2.1 - TraceabilityStrategies for implementing SDTM and ADaM standardsSusan Kenny – Michael Litzsinger • Hybrid method DBMS Extract → SDTM Draft Domains → Analysis Datasets → SDTM Final Domains • Traceability • Amendment 1 SDTM V1.2 and SDTM IG V3.1.2 • Future?!?

  31. CDISC ADaM V2.1 - Traceability • Traceability → Recommended: Linear method • Flexible • Delivery of consistent analysis datasets • Easy to use (Excel file) • Easy to maintain (Excel file)

  32. Agenda • CDISC - Introduction • CDISC - Foundational standards • CDISC ADaM V2.1 - Analysis data flow • CDISC ADaM V2.1 - ADaM data structures • CDISC ADaM V2.1 - Traceability • CDISC ADaM V2.1 - ADaM metadata • CHKSTRUCT macro • Linear method - Challenges and solutions • Take home messages

  33. CDISC ADaM V2.1 - ADaM metadata • Microsoft Office Excel spreadsheet as framework • Metadata

  34. CDISC ADaM V2.1 - ADaM metadata • Microsoft Office Excel spreadsheet as framework • analysis dataset • %CHKSTRUCT(ds_ = ) • Automatization • Compliance • define.xml

  35. CDISC ADaM V2.1 - ADaM metadata • Analysis dataset metadata • Analysis variable metadata • Analysis parameter value-level metadata • Analysis results metadata

  36. CDISC ADaM V2.1 - ADaM metadataAnalysis dataset metadata • Illustration from CDISC ADaM V2.1 • Practical consideration: ADxxxxxx ! ≠ SDTM ! The key variables should define uniqueness

  37. CDISC ADaM V2.1 - ADaM metadataAnalysis dataset metadata Analysis dataset naming convention • ADxxxxxx • The subject-level analysis dataset is named ADSL • max. 8 characters

  38. CDISC ADaM V2.1 - ADaM metadata • Analysis dataset metadata • Analysis variable metadata • Analysis parameter value-level metadata • Analysis results metadata

  39. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata • Illustration from CDISC ADaM V2.1

  40. CDISC ADaM V2.1 - ADaM metadata • Analysis dataset metadata • Analysis variable metadata • Analysis parameter value-level metadata • Analysis results metadata

  41. CDISC ADaM V2.1 - ADaM metadataAnalysis parameter value-level metadata • Illustration from CDISC ADaM V2.1

  42. CDISC ADaM V2.1 - ADaM metadata • Analysis dataset metadata • Analysis variable metadata • Analysis parameter value-level metadata • Analysis results metadata (not required)

  43. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice Analysis dataset metadata Analysis variable metadata Dataset name Display format Variable name Codelist / Controlled terms Variable label Source / Derivation Variable type Parameter identifier (Basic Data Structure (BDS)) Analysis results metadata (not required)

  44. CDISC ADaM V2.1 - ADaM metadata • Microsoft Office Excel spreadsheet as framework • Metadata

  45. SAS variable attributes To work in a SAS environment NAME TYPE LENGTH FORMAT INFORMAT LABEL POSITION IN OBSERVATION INDEX TYPE Analysis variable metadata fields DATASET NAME VARIABLE NAME VARIABLE LABEL VARIABLE TYPE DISPLAY FORMAT CODELIST / CONTROLLED TERMS SOURCE / DERIVATION BASIC DATA STRUCTURE:PARAMETER IDENTIFIER CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice

  46. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice • Example ...

  47. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice - Subposition in observation • Example • ADSL – SITEGR* (Char) and SITEGR*N (Num) * = a single digit [1-9] • SITEID • SITEID grouped together by city in the variable SITEGR1 (SITEGR1N) • SITEID grouped together by province in the variable SITEGR2 (SITEGR2N)

  48. 1 1 2 2 CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice - Subposition in observation ORDER %CHKSTRUCT(ds_ = ADSL)

  49. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice - Subposition in observation ORDER 1 2 1 2

  50. CDISC ADaM V2.1 - ADaM metadataAnalysis variable metadata in practice - Subposition in observation Example ADSL – SITEGR* (Char) and SITEGR*N (Num) * = a single digit [1-9]

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