Legacy Data Conversion Plan & Report Conversion The legacy data was converted to SDTM as described in the following data flow diagram. Rationale: The legacy data was converted to SDTM without creating ADaM datasets since the study started before December 17, 2016. The rationale for only converting to SDTM was to support pooling activities for the ISS and ISE. The tabulation data was pooled at the SDTM level and ADaM datasets were created to be used as input for the ISS/ISE. Converted Data Summary The legacy data was available in SAS format (.sas7bdat). A formats catalog was applied to the datasets prior to conversion to SDTM in order to aid in source-to-target mapping (e.g. straight map or minimal conditional statements needed). During authoring of the mapping specification from legacy data to SDTM, CDISC Controlled Terminology was applied where applicable. After authoring of a mapping specification and programming of the SDTM SAS datasets, the Pinnacle21 validator was run to check compliance to SDTMIG v3.1.3. Any checks that signified a programming issue were addressed and the relevant SDTM datasets were updated. After resolution of all validation issues that could be fixed, a QC step was performed where the datasets were double-programmed by a separate QC programmer using the mapping spec as a reference. Any fallouts were recorded per the and returned to the SDTM programmer for updates. After sponsor’s SOPs confirmation that updates were applied properly, the SDTM data was considered complete and sent to a publishing programmer for creation of the SDTM annotated CRF as well as the define.xml. Each of these tasks included QC steps as well. Issues Encountered and Resolved MedDRA v14.1 was used to encode adverse events in the legacy data for this study. This version was retained when mapped to the SDTM AE domain to maintain traceability to the CSR. Terms will be re-coded to MedDRA v20.0 at the pooled SDTM level per advice in the Technical Conformance Guide to encode to one version of the dictionary. A
Legacy Data Conversion Plan & Report Conversion The legacy data was converted to SDTM as described in the following data flow diagram. Rationale: The legacy data was converted to SDTM without creating ADaM datasets since the study started before December 17, 2016. The rationale for only converting to SDTM was to support pooling activities for the ISS and ISE. The tabulation data was pooled at the SDTM level and ADaM datasets were created to be used as input for the ISS/ISE. Converted Data Summary The legacy data was available in SAS format (.sas7bdat). A formats catalog was applied to the datasets prior to conversion to SDTM in order to aid in source-to-target mapping (e.g. straight map or minimal conditional statements needed). During authoring of the mapping specification from legacy data to SDTM, CDISC Controlled Terminology was applied where applicable. After authoring of a mapping specification and programming of the SDTM SAS datasets, the Pinnacle21 validator was run to check compliance to SDTMIG v3.1.3. Any checks that signified a programming issue were addressed and the relevant SDTM datasets were updated. After resolution of all validation issues that could be fixed, a QC step was performed where the datasets were double-programmed by a separate QC programmer using the mapping spec as a reference. Any fallouts were recorded per the sponsor’s SOPs and returned to the SDTM programmer for updates. After confirmation that updates were applied properly, the SDTM data was considered complete and sent to a publishing programmer for creation of the SDTM annotated CRF as well as the define.xml. Each of these tasks included QC steps as well. Issues Encountered and Resolved MedDRA v14.1 was used to encode adverse events in the legacy data for this study. This version was retained when mapped to the SDTM AE domain to maintain traceability to the CSR. Terms will be re-coded to MedDRA v20.0 at the pooled SDTM level per advice in the Technical Conformance Guide to encode to one version of the dictionary. A