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How to go from an SDTM Finding Domain to an ADaM-Compliant Basic Data Structure Analysis Dataset: An Example

How to go from an SDTM Finding Domain to an ADaM-Compliant Basic Data Structure Analysis Dataset: An Example. Qian Wang, MSD, Brussels, Belgium Carl Herremans, MSD, Brussels, Belgium. PhUSE 2010, Berlin. ADaM versus SDTM.

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How to go from an SDTM Finding Domain to an ADaM-Compliant Basic Data Structure Analysis Dataset: An Example

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  1. How to go from an SDTM Finding Domain to an ADaM-Compliant Basic Data Structure Analysis Dataset: An Example Qian Wang, MSD, Brussels, Belgium Carl Herremans, MSD, Brussels, Belgium PhUSE 2010, Berlin

  2. ADaM versus SDTM • ADaM datasets do use redundancy for easy analysis – common variables may be found across all analysis datasets (e.g., population flags, subject identifiers, etc.); • ADaM datasets have a greater number of numeric variables (e.g., SAS formatted dates, numeric representation of a character grouping variable from SDTM); • ADaM datasets may combine variables from multiple SDTM domains; • ADaM datasets are named AD<xxxxxx>. PhUSE 2010 - Berlin

  3. ADaM-compliantBasic Data Structure (BDS) • A BDS dataset contains one or more records per subject, per analysis parameter and per analysis time point. • It describes the data being analyzed and also includes variables to support the analysis (e.g. covariates) as well as information to facilitate traceability. PhUSE 2010 - Berlin

  4. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  5. STEP 1: Preparing for ADAM Precursor by Adding SUPPQUAL to SDTM LB LB + SUPPQUAL (where RDOMAIN=‘LB’) SUPPQUAL PhUSE 2010 - Berlin

  6. STEP 1: Preparing for ADAM Precursor by adding SUPPQUAL to SDTM + PhUSE 2010 - Berlin

  7. STEP 1: Preparing for ADAM Precursor by Adding SUPPQUAL to SDTM proc transpose data=supplb out=supplb2 (rename=(idvarval=lbseq)); by usubjid idvarval; var qval; id qnam; idlabel qlabel; run; %addsuppqual(input_libary =, input_dataset_suppqual =, input_dataset_define =, output_library = ); PhUSE 2010 - Berlin

  8. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  9. STEP 2: Converting ISO8601 Date/Time PhUSE 2010 - Berlin

  10. STEP 2: Converting ISO8601 Date/Time If not missing ADT and ATM populate ADTM PhUSE 2010 - Berlin

  11. STEP 2: Converting ISO8601 Date/Time %convert2date(input_dataset=, output_dataset= ); PhUSE 2010 - Berlin

  12. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  13. STEP 3: Creating Analysis Relative Day ADY = LBDT - ADSL. TRTSDT + (LBDT > ADSL.TRTSDT) PhUSE 2010 - Berlin

  14. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  15. STEP 4: Creating Key Analysis Parameter Variables PARAM(CD), AVAL SDTM LB ADaM ADLB PhUSE 2010 - Berlin

  16. STEP 4: Creating Key Analysis Parameter Variables PARAM(CD), AVAL SDTM LB ADaM ADLB PhUSE 2010 - Berlin

  17. STEP 4: Creating Key Analysis Parameter Variables PARAM(CD), AVAL %finding(input_dataset=, domain=, summaryfunction=AVERAGE, output_dataset= ); PhUSE 2010 - Berlin

  18. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  19. STEP 5: ADDING TIME WINDOWS -70 1 7 90 180 Time Baseline Treatment 1 Treatment 2 PhUSE 2010 - Berlin

  20. STEP 5: ADDING TIME WINDOWS PhUSE 2010 - Berlin

  21. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline 6 Basic Steps PhUSE 2010 - Berlin

  22. Step 6: Deriving Change From Baseline %change(input_dataset=, input_timewindow_dataset=, output_dataset= ); PhUSE 2010 - Berlin

  23. Step 1 Prepare ADaM Precursor Step 2 Convert ISO8601 Dates Step 3 Create Analysis Relative Day Step 4 Create Key Analysis Variables Step 5 Add Time Windows Step 6 Derive Change from Baseline Conclusion 6 Steps have been described to transform a SDTM finding dataset into an ADaM-compliant BDS analysis dataset. PhUSE 2010 - Berlin

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