Fabienne NOEL CDISC – 2013, December 18th How to CDISC in Sanofi… Fabienne NOEL CDISC – 2013, December 18th

Agenda Previous model Linear model overview Sanofi SDTM Sanofi ADS The futur …

Previous model: from 2009

Why to change ? FDA has stated "Analysis datasets should be derivable from the SDTM datasets, in order to enable traceability from analysis results presented in the study reports back to the original data elements collected in the case report form and represented in the SDTM datasets" The FDA does not receive the "raw" data. Therefore, any derivation documentation or programs/code used to derive ADS variables, or to include SDTM variables in the ADS, can not refer to raw variables. ADS/SDS creation and validation of SDTM after ADS caused problems When SDTM needed to change it was too late to change the ADS (already used for TLGs), so SDTM and ADS were out of sync.

From 2012 Linear Model SDTM domains are created and validated in a first step; and then, in a second step, the ADS domains are created using the SDTM domains. SDTM: variables are mapped using raw (e.g., OC) data when feasible, derived variables (e.g., --DY, --BLFL) use existing SDTM variables in their derivation (not raw data) ADS: may not use any raw data; the source for all variables must be the SDTM datasets (and other variables within the ADS submission). not all variables from the SDTM domains will be retained not all records from the SDTM may be retained and additional records may be added only ADS that are required to support an analysis should be created

From 2012 : Data flow in a Linear Model

A Look at Sanofi SDTM

Sanofi SDTM Standards Based on: SDTMIG version 3.1.2 Amendment 1 to SDTMIG CDER Common Data Standards Issues Document v1.1 CDISC Oncology domains Stricter adherence to CT FDA wishes stated at CDISC Interchange, at CDISC meetings, etc.

Validation of SDTM SDTM must be final and validated prior to use for listing or creation of ADS OpenCDISC Checks fix all avoidable errors document in a reviewers guide all that can’t be avoided Sanofi checks Double programming of key variables - derivations

A Look at Sanofi ADS

What ADS are created? Subject Level (ADSL) is mandatory Any other ADS is not created unless used for an analysis No one to one correspondence between SDTM and ADS

ADS must be "Analysis Ready" ADS should have a structure and content that allow statistical analyses to be performed with minimal programming FDA stopped using the term one-proc-away because it was misleading Analysis-ready does not mean that a formatted table can be generated in a single statistical procedure. Rather it means that each statistic (cell) in the table can be replicated without derivations or merging (with certain exceptions) However, it should not be necessary to have to transpose an ADS to produce a table, figure, or graph The exceptions: it is allowable to perform formatting in the reporting program because formats (e.g., rendering RACE to title case) are not used for calculating the "statistic" and are not considered derivations it is allowable to merge to ADSL in order to be able to determine denominators it is allowable to have the TLG program filter (select records) or sort the data ADS do not need to be analysis ready to produce a listing (i.e., if used to create a listing)

Sanofi ADS Standards Based on: Previous SDTM+ model with a move to linear Added variables/CT based on ADaMIG and review period requests Sanofi specific rules ADS domains defined Naming conventions Derivation definitions

Validation of ADS ADS must be final and validated prior to use for TLG Sanofi checks Check of data against Sanofi variable metadata and controlled terminology (chk_sads_meta.sas) Level of validation to be determined based on Validation matrix

And the planned futur… http://www.youtube.com/watch?v=gCyVdvgVpY8#t=13

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