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SDTM METHODOLOGY

For SDTM mapping, Protocol and CRF will serve as the initial supporting document. Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in the CRF against the SDTM domains. Trial Design Model Domains (TDM) will also be developed in parallel in the initial stage itself. SDTM specification will be developed against the aCRF to map the raw data into SDTM domains specifying the characteristics of each and every variable for all the applicable SDTM domains. According to this Specification along with the support of aCRF and TDM the programmer will start the programming of SDTM domains. Define.xml for SDTM will be created after the finalization of aCRF, SDTM specifications and SDTM datasets. For the mapping of ADaM domains, Statistical Analysis Plan (SAP) will also be required. Against the finalized SAP and SDTM datasets the ADaM specification will be created. After the completion of ADaM specification programmer will start working on the generation of ADaM dataset. When both ADaM…

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