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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published two three new FAQs! They have answered a FAQ two FAQs within Data Submission, the FAQ answered looks at the ‘Correct Implementation of the Define-XML Standard for Submission Purposes – ADaM and SDTM Variable Alignment’ and ‘Correct Implementation of the Define-XML Standard for Submission Purposes – Clarifications Needed’. You can view this question ‘Upversioning SDTM and ADaM Datasets for Older Studies’ and ‘Annotated CRFs for EDC and eCOA’. They have also answered a FAQ within SDTM/ADaM IG Nuances, that FAQ answered looks at the “ADAE dataset: AESEQ or SRCDOM and SRCSEQ' You can view these questions and see the FAQ's this project has answered so far here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
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