optimization of the traceability when applying an adam parallel si04 conversion … · 2018. 11....
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Roxane Debrus
Optimization of the traceability when applying an ADaM Parallel Conversion MethodSI04
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ADaM Conversion Process
%LIB_QC_contents_html
%adam_sdtm_compa
Conclusion
ADaM Conversion ProcessAgenda
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ADaM Conversion Process
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ADaM Conversion Process
ParallelMethod
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ADaM Conversion ProcessWhy traceability ?
Understand the analysis datasets structure
Identify the data collected and algorithms used to derive variables
Understand how analysis was performed
Relate counts from CSR’s TFL to the underlying data
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“Based on reviewer experience, establishing traceability is one of the most problematic issues associated with any data conversion”
Reference : FDA, “Technical Specifications Document: Study Data Technical Conformance Guide”, Version 4.1, Issued March 31, 2018
8 Specific issues identified
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ParallelMethod
ADaM Conversion Process
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ROI² return on investment through return on information
ADaM Conversion Process
%LIB_QC_contents_html
%adam_sdtm_compa
Conclusion
Agenda
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%LIB_QC_contents_htmlCharacteristics Reads any type of libraries (CDISC compliant and Legacy) Report a description of each dataset and its content Produces a set of HTML files
Outputs Global library description Detailed description for each dataset Main characteristics:
variable name, label, type and length Content description:
N distinct, N missing, Mean, Min, Max
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%LIB_QC_contents_html
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%LIB_QC_contents_htmlCategorical Variables
Discrete Variables
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%LIB_QC_contents_htmlContinuous Variables
Empty variable
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%LIB_QC_contents_htmlPractical Example 1
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%LIB_QC_contents_htmlPractical Example 2According to the ADaM IG, population flags shouldn’t have a missing value and should be always equal to “Y” or “N”.
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%LIB_QC_contents_htmlAdvantagesEasy to produce, Easy to integrate,Easy to share, Easy to open, Easy to read
How to call it%LIB_QC_contents_html(SDTM);%LIB_QC_contents_html(W:\PROJECT-X\STUDY-0001\SDTM);
Option(s): %LIB_QC_contents_html(SDTM, select=DM AE);%LIB_QC_contents_html(SDTM, APPLY_FORMATS=Yes);
Options can be combined
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%LIB_QC_contents_htmlLimitations No possible “filter” or “subset by” Free text variables No annotations possible
Improvements Develop new options for
Selection Display Output format
Compare collected values with expected values
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ROI² return on investment through return on information
ADaM Conversion Process
%LIB_QC_contents_html
%adam_sdtm_compa
Conclusion
Agenda
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%adam_sdtm_compaCharacteristics Compare SDTM vs. ADaM data and metadata Based on 8 major CDISC principles
Outputs Reports a description of all findings Produces one XML workbook
Summary SDTM Overview ADaM Overview Exception Metadata Exception Data Log Overview
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%adam_sdtm_compa8 major CDISC principles
Check #101: A variable present in ADaM is indicated as a copy of a variable present in SDTM but the variables do not have identical metadata attributes
Check #102: A variable present in ADaM is indicated as a copy of a SDTM variable but the SDTM variable does not exist in SDTM variable metadata
Check #103: A variable present in ADaM is indicated as a derived variable but the same SDTM variable name exist in SDTM variable metadata
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%adam_sdtm_compa8 major CDISC principles
Check #104: SDTM.EX is present and neither ADSL.TRTSDT or ADSL.TRTSDTM are present
Check #105: The variable referenced in the computational algorithm of the ADaM variable does not exist in SDTM or ADaM variable metadata
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%adam_sdtm_compa8 major CDISC principles
Check #201: A variable present in ADaM is indicated as a copy of a variable present in SDTM but the values are not identical
Check #202: The values of USUBJID are not present in SDTM.DM
Check #203: SRCDOM has a value that is not a SDTM dataset, an ADaM dataset name or null
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AdvantagesEasy to produce, Easy to integrate, Easy to archiveEasy to share, Easy to open, Easy to read
How to call it%adam_sdtm_compa (
studyid= STUDY-0001, sdtm_path= W:\PROJECT-X\STUDY-0001\SDTM\Metadata,sdtm_data= W:\PROJECT-X\STUDY-0001\SDTM,adam_path= W:\PROJECT-X\STUDY-0001\ADAM\Metadata,adam_data= W:\PROJECT-X\STUDY-0001\ADAM
);
%adam_sdtm_compa
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Limitations False positive (#101, #105) Executable only on BDLS’s conversion
Improvements Refinement of existing checks Addition of new checks Develop the macro to extract metadata from the Define.xml
%adam_sdtm_compa
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ROI² return on investment through return on information
ADaM Conversion Process
%LIB_QC_contents_html
%adam_sdtm_compa
Conclusion
Agenda
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ADaM Conversion Process
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Optimized ADaM Conversion Process
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Optimized ADaM Conversion Process
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Optimized ADaM Conversion ProcessAdded Value ? Traceability is one of the main goals of ADaM generation Identified by FDA as one of the most problematic issues during submission Optimization is possible with automated checks (SAS Macro) Can be included into actual SOP
Undoubtedly a return on investment
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Roxane DEBRUS
Biostatistician, Project [email protected]
+32 475 95 35 00
Come to meet us at Phuse Booth #36