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Copyright © 2012 Quintiles Analysis Data Model (ADaM) Case Studies Wouter van Wyk, 27 Sep 2012.

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Presentation on theme: "Copyright © 2012 Quintiles Analysis Data Model (ADaM) Case Studies Wouter van Wyk, 27 Sep 2012."— Presentation transcript:

1 Copyright © 2012 Quintiles Analysis Data Model (ADaM) Case Studies Wouter van Wyk, 27 Sep 2012

2 2 Case Studies With the increased adoption of the Analysis Data Model (ADaM) we are facing a shift in our approach to creating Analysis datasets, as we are encouraged to create records rather than adding additional variables as we might have in the past. With these Case Studies I hope to address some of the questions around: Mapping multiple SDTM Variables to the same ADaM variable Creating derived records Multiple baseline definitions in the same ADaM domain Specific to Basic Data Structure (BDS)

3 3 Mapping multiple SDTM Variables to the same ADaM variable Finding domains >Eg. LB, VS, EG >**ORRES, **STRESN Map to BDS >AVAL, AVALC Multiple variables mapping to a single ADaM BDS Result variable Traceability >SRCDOM, SRCSEQ, SRCVAR

4 4 Mapping multiple SDTM Variables to the same ADaM variable DOMAINVSSEQVISITVSTESTVSORRESVSORRESUVSSTRESNVSSTRESU VS1SCRWEIGHT158.7LB72kg VS2V1WEIGHT162LB73.5kg VS3V2WEIGHT161.8LB73.4kg VS4V3WEIGHT161.6LB73.3kg VS5V4WEIGHT162.3LB73.6kg VS6V5WEIGHT163LB74kg SDTM VS Dataset

5 5 Mapping multiple SDTM Variables to the same ADaM variable SRCDOMSRCSEQSRCVARVISITPARAMAVAL VS1VSORRESSCRWEIGHT (LB)158.7 VS1VSSTRESNSCRWEIGHT (kg)72 VS2VSORRESV1WEIGHT (LB)162 VS2VSSTRESNV1WEIGHT (kg)73.5 VS3VSORRESV2WEIGHT (LB)161.8 VS3VSSTRESNV2WEIGHT (kg)73.4 VS4VSORRESV3WEIGHT (LB)161.6 VS4VSSTRESNV3WEIGHT (kg)73.3 VS5VSORRESV4WEIGHT (LB)162.3 VS5VSSTRESNV4WEIGHT (kg)73.6 VS6VSORRESV5WEIGHT (LB)163 VS6VSSTRESNV5WEIGHT (kg)74

6 6 Mapping multiple SDTM Variables to the same ADaM variable Traceability >The property that enables the understanding of the data’s lineage and/or the relationship between an element and its predecessor(s). >Where did the data come from? SRCDOM: Identifies the SDTM domain SRCSEQ: Identifies the record in the SDTM domain SCRVAR: Identifies the SDTM variable used to create AVAL/AVALC

7 7 Creating derived records Derived Parameters >Test is not present in SDTM -BMI, BSA, -Calculated Creatinine Clearance -QTcF, QTcB Derived Value >Test is in SDTM, but the record is not -Baseline, -Endpoint -Last Observation Carried Forward Traceability >PARAMTYP vs. DTYPE

8 8 Creating derived records RowUSUBJIDVISITAVISITADYPARAMAVAL 11001BASELINE -4 SUPINE SYSBP (mm Hg) 145 21001WEEK 1 3 SUPINE SYSBP (mm Hg) 130 31001WEEK 2 9 SUPINE SYSBP (mm Hg) 133 41001WEEK 3 20 SUPINE SYSBP (mm Hg) 125 51002BASELINE SUPINE SYSBP (mm Hg) 145 61002WEEK 1 7 SUPINE SYSBP (mm Hg) 130 71002WEEK 3 22 SUPINE SYSBP (mm Hg) 135 81003BASELINE 1 SUPINE SYSBP (mm Hg) 150 91003WEEK 1 8 SUPINE SYSBP (mm Hg) 140 DTYPE LOCF

9 9 Creating derived records RowUSUBJIDVISITAVISITADYPARAMAVALDTYPE 11001BASELINE -4 SUPINE SYSBP (mm Hg) 145 21001WEEK 1 3 SUPINE SYSBP (mm Hg) 130 31001WEEK 2 9 SUPINE SYSBP (mm Hg) 133 41001WEEK 3 20 SUPINE SYSBP (mm Hg) 125 51002BASELINE SUPINE SYSBP (mm Hg) 145 61002WEEK 1 7 SUPINE SYSBP (mm Hg) 130 71002WEEK 1WEEK 27 SUPINE SYSBP (mm Hg) 130LOCF 81002WEEK 3 22 SUPINE SYSBP (mm Hg) 135 91003BASELINE 1 SUPINE SYSBP (mm Hg) 150 101003WEEK 1 8 SUPINE SYSBP (mm Hg) 140 111003WEEK 1WEEK 28 SUPINE SYSBP (mm Hg) 140LOCF 121003WEEK 1WEEK 38 SUPINE SYSBP (mm Hg) 140LOCF

10 10 Creating derived records Duplicate the needed record Populate DTYPE to indicate new record >Use something descriptive like, LOCF, BASELINE, ENDPOINT, WCCF SCRDOM, SRCVAR, SRCSEQ populated as with original record Do not modify SDTM variables

11 11 Creating derived records RowPARAMPARAMCDAVISITAVISITNAVALPARAMTYP 1Weight (kg)WEIGHTSCR-4 99 2Weight (kg)WEIGHTRUN-IN-2 101 3Weight (kg)WEIGHTBASELINE0 100 4Weight (kg)WEIGHTWEEK 2424 94 5Weight (kg)WEIGHTWEEK 4848 92 6Weight (kg)WEIGHTWEEK 5252 95 7Log10(Weight (kg))L10WTSCR-4 1.9956 DERIVED 8Log10(Weight (kg))L10WTRUN-IN-2 2.0043 DERIVED 9Log10(Weight (kg))L10WTBASELINE0 2 DERIVED 10Log10(Weight (kg))L10WTWEEK 2424 1.9731 DERIVED 11Log10(Weight (kg))L10WTWEEK 4848 1.9638 DERIVED 12Log10(Weight (kg))L10WTWEEK 5252 1.9777 DERIVED PARAMTYP

12 12 Creating derived records Add records needed New value for PARAM and AVAL SRCSEQ, SRCDOM, SRCVAR will be NULL >AVAL did not have SDTM as source SDTM variables can be populated as appropriate Do not modify SDTM variables

13 13 Multiple baseline definitions in the same ADaM domain Multiple definitions of Baseline >Last value prior to very first dose of active >Last value prior to Run-in Last value prior to Double-Blind Last value prior to Open Label In case there is more than one definition of baseline, new rows must be created for each additional alternative definition of baseline Some data redundancy is expected BASETYPE

14 14 Multiple baseline definitions in the same ADaM domain RowBASETYPEEPOCHAVISITAVALABLFLBASECHG 1RUN-IN BASELINE34.5Y 0 2RUN-IN DAY 1011.634.5-22.9 4RUN-INSTABILIZATIONDAY 1513.134.5-21.4 6RUN-INDOUBLE BLINDDAY 2013.734.5-20.8 7RUN-INDOUBLE BLINDDAY 2519.734.5-14.8 8RUN-INDOUBLE BLINDDAY 3028.134.5-6.4 10RUN-INOPEN LABELDAY 3528.434.5-6.1 11RUN-INOPEN LABELDAY 4030.534.5-4 CDISC ADaM IG v1.0 Table 4.2.1.11

15 15 Multiple baseline definitions in the same ADaM domain RowBASETYPEEPOCHAVISITAVALABLFLBASECHG 1RUN-IN BASELINE34.5Y 0 2RUN-IN DAY 1011.634.5-22.9 4RUN-INSTABILIZATIONDAY 1513.134.5-21.4 6RUN-INDOUBLE BLINDDAY 2013.734.5-20.8 7RUN-INDOUBLE BLINDDAY 2519.734.5-14.8 8RUN-INDOUBLE BLINDDAY 3028.134.5-6.4 10RUN-INOPEN LABELDAY 3528.434.5-6.1 11RUN-INOPEN LABELDAY 4030.534.5-4 12DOUBLE BLIND DAY 2013.7Y 0 13DOUBLE BLIND DAY 2519.713.76 14DOUBLE BLIND DAY 3028.113.714.4 15DOUBLE BLINDOPEN LABELDAY 3528.413.714.7 16DOUBLE BLINDOPEN LABELDAY 4030.513.716.8

16 16 Multiple baseline definitions in the same ADaM domain Duplicate all records affected Populate BASETYPE with something descriptive SRCVAR, SRCDOM, SRCSEQ will be populated as records can be traced back to SDTM Some data redundancy is expected

17 17 Summary SRCVAR, SRCDOM, SRCSEQ used when multiple SDTM variables map to AVAL >E.g. **ORRES and **STRESN DTYPE used when new record is created but AVAL is not modified. >E.g. LOCF PARAMTYP used when new parameter is created and value of AVAL can not be traced back to SDTM BASETYPE used when there are multiple baseline definitions that require additional records to be added

18 18 Questions?


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