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The day was mostly in Italian, except for the presentations provided by three of our E3C colleagues, .
This time we didn't chose a specific topic and we left to volunteers and invited speakers to chose the topic of their preference. The result was an agenda full of interesting presentations, ranging from SEND (first time covered at any Italian CDISC event) to Real World Data, looking at the future with a presentation on Linked data, some update from CDISC SDTM Team member on Multiple Enrollments and Screenings Subjects and some good user experience on either SDTM or ADaM or conformance or data submission.
Until the next event, the Italian CDISC UN continues to be active with the regular calls, the LinkedIn group and the CDISC wiki page, where further information on the activities of the Italian CDISC UN, together with the presentations of the day (all slides in english):
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- Efficiently leveraging your RWD investment across the product life cycle, Stijn Rogiers, SAS CDISC Italian User Network 2020_Stijn Rogiers_RWE_Final.pdfValidation Rules and Validation Tools, Silvia Faini, Livanova 4_ItalianCDISC2020_ValidationRules_ValidationTools_Faini_updated.pdfCDISC SEND Data Standardization and Exploration, Marco Pergher, Aptuit 5_CDISC SEND oct2020 SIMEF v5.pdfNews from the Regulatory World, Angelo Tinazzi, Cytel Inc. CDISC-ITA-2020-Novità Mondo Regolatorio-Tinazzi.pdf
- Efficacy ADaM datasets applicable to all solid tumor studies, Letizia Nidiaci, Menarini 6_CDISC-2020-Efficacy ADaM datasets Final_Milano.pdf
- Protocol Deviations and Quality in Vaccines Trials, Angela Gambioli, GSK PROTOCOL DEVIATIONS AND QUALITY IN VACCINES TRIALS_Gambioli_sep.pdf
- Updates on Handling Multiple Enrollments and Screenings Subjects in SDTM, Éanna Kiely, ClinBuild Updates on Handling Multiple Enrollments and Screenings Subjects in SDTM - ClinBuild - Eanna Kiely - V1.0.pdf
The day was also completed by a pre workshop on "define-xml and submission ready documents" with 26 attendee. See here Q&A received during the workshop IBIG-CDISC-define-xml and submission-ready-documents-Q&A_20200928.pdf.
A collection of pictures of our virtual speakers:
