From SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines

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1 From SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines Omar SEFIANI - Stéphane BOUGET, Boehringer Ingelheim DH13, PhUSE Barcelona 2016, October, 12 th

2 Outline Background Metadata Driven Programming Metadata Repository SDTM mapping & derivations ADaM implementation Analysis Results Metadata (ARM) Data exportation / documentation Summary DH13 - PhUSE - Barcelona

Background Many changes can occur during the conduct of a project: v standard updates leading to structural changes v new scientific approaches v new regulatory requests Find a solution to: v Reduce

3 Background Many changes can occur during the conduct of a project: v standard updates leading to structural changes v new scientific approaches v new regulatory requests Find a solution to: v Reduce maintenance effort v Increase readability v Ensure consistency between similar implementations => One single program per area dealing with multiple trials simultaneously (centric approach) DH13 - PhUSE - Barcelona

4 Metadata Driven Programming (1/2) Metadata used for: v Generic SAS programs development v SAS Code generation v Multiple small macros implementation (elementary tasks) v Modular programming using KEYWORDS The concept presented is currently used in a multi-trial respiratory project v BI legacy data conversion to SDTM v ADaM transformation v Reporting program generation DH13 - PhUSE - Barcelona

5 Metadata Driven Programming (2/2) Definition of algorithms Identification in the code via meaningful KEYWORDS describing the functionality - Flexibility - Reduction of maintenance efforts - Centralization and automatization DH13 - PhUSE - Barcelona

6 Metadata repository (1/4) MS Excel or any MDR system SDTM / ADAM One sheet per SDTM domain / ADAM dataset (structure) Differentiation of variable types (mapped or derived / predecessor or derived) Controlled Terminology SDTM only embedded Link derived variables to derivation methods keywords One sheet for all methods (link keyword to SAS macro) ARM TOC (Table of contents Generator) : - Unique display template - Output (TLF) - Statistics for main analyses DH13 - PhUSE - Barcelona

7 Metadata repository (2/4): SDTM DM domain DH13 - PhUSE - Barcelona

8 Metadata repository (3/4): ADaM setup dataset DH13 - PhUSE - Barcelona

9 Metadata repository (4/4): ARM DH13 - PhUSE - Barcelona

10 SDTM mapping and derivations (1/2) SDTM transformation engine : All legacy data converted to SDTM on an ongoing basis Includes additional non-required information by SDTM (e.g. flags) Step 1 : SDTM mapping one-to-one relationship between one legacy variable and one SDTM variable obtain a bijection between one raw value and one SDTM value Step 2 : SDTM derivations after all domains are created facilitating the interaction between different domains execution order needed example : EPOCH variable derived first in SE and then populated in other domains DH13 - PhUSE - Barcelona

11 SDTM mapping and derivations (2/2) Structure check Legacy raw data Legacy normalised database structure SAS Bijectivity check SDTM Domains raw data Derivation SAS SDTM Domains final data Data preparation Mapping EXCEL METADATA SDTM transformation Definition : - Raw data preparation - Domains - Mapping - Derivations SAS Content check D E F I N E SAS Exportation XPT files DH13 - PhUSE - Barcelona

main sheet as Assigned variables to be extracted from the define.

12 ADaM implementation (1/3) Metadata ADaMs Global datasets that contains attributes (study or patient level) Can be used by all subsequent ADaMs Automatically replicated to the main sheet as Assigned variables to be extracted from the define.xml during the creation of the ADS. Manual entry ADaM dataset ADTARM in ADS plan DH13 - PhUSE - Barcelona

13 ADaM implementation (2/3) Setup metadata datasets Contains algorithms identification Read via a generic macro Used to generate a SAS program creating the corresponding metadata dataset Used as setup dataset during the creation of an ADaM DH13 - PhUSE - Barcelona

14 ADaM implementation (3/3) DH13 - PhUSE - Barcelona

15 Analysis Result Metadata (ARM) (1/2) ARMs used to: Automatically create the ARM section in the define.xml V2 for ADaMs Dynamically generate a part of SAS macro calls for displays An output program generator is currently under development to automatically generate the different macro calls for: Data building (ADaM preparation) Analysis & reporting (calculation+output) DH13 - PhUSE - Barcelona

16 Analysis Result Metadata (ARM) (2/2) Table Of Content (metadata repository) TO C Output description Statistical part of ARM GENERAT OR Data selection Macros parametrization ARMs SAS MACROS DH13 - PhUSE - Barcelona

17 Data exportation / documentation SDTM ADAM ARM Define.xml generated automatically at each execution.xpts generated at the same time Pinnacle 21 checks performed Bijectivity check Possible data restriction for the export Define.xml main source of metadata for the ADaMs creation.xpts generated at the same time Pinnacle 21 checks performed Analysis Data Reviewer s Guide contains partially derived information based on the ADS plan Present in the define.xml Synchronized with the displays Standardized results datasets exported for validation DH13 - PhUSE - Barcelona

Summary Powerful approach to minimize risks of inconsistencies across different packages and studies - fits with a project centric approach (multiple trials) Development of programs in a generic

18 Summary Powerful approach to minimize risks of inconsistencies across different packages and studies - fits with a project centric approach (multiple trials) Development of programs in a generic manner: v high level of control needed (user ERRORs and WARNINGs ) v custom code or hardcoding should be avoided v good level of algorithmic and use of complex technical solutions (eg. hashcode, extended attributes, arrays, dosubl, multi-level embedded macros, ) Synergy between standardization and flexibility v more flexible with data diversity v reduction of implementation time and maintenance facility v improvement in productivity for the creation of similar outputs DH13 v - PhUSE facilitates - Barcelona 2016 delegation and simplify oversight 18

19 Thank you Omar SEFIANI Stéphane BOUGET DH13 - PhUSE - Barcelona

Out-of-the-box %definexml

Out-of-the-box %definexml Just a Simple SAS Macro PhUSE / October 2016 / Katja Glaß Agenda Introduction Getting Started %DefineXML Collaborate Summary Page 2 DefineXML Katja Glaß 11. October 2016 Introduction