7 October 2020, Virtual
The 7thth Italian CDISC User Network Annual Meeting was planned to be held in Milan Friday 28th February 2020 at the SAS office. That was a terrific week in Italy in particular in the Milan area: it was the official start of the COVID-19 pandemic issue.
Eight months later, in collaboration with IBiG, the Italian Association of Biostatisticians, and sponsored by Cytel, we did run the event virtually.
Despite it was for us the first time organizing a virtual event, the event was a success in terms of numbers with more than 90 registrations, with more than 80 of them connecting during the event.
Silvia Faini (Livanova) and Angelo Tinazzi (Cytel), who are active part of the Italian CDISC UN as well as members of the CDISC European Committee (E3C), chaired the event.
The day was mostly in Italian, except for the presentations provided by three of our E3C colleagues, Johannes Ulander Stijn Rogiersand Éanna Kiely.
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):
- Benvenuti+Intro CDISC E3C Silvia Faini, Livanova Inc. A_Intro_ITA_CDISC_and_global_SF_AT_20201007-Final.pdf
- Deconstructing SDTM Johannes Ulander , S-Cubed 2020-02-28-CDISC-ITUN-Johannes-Ulander.pdf
- Re-mastering the define-xml and its brother the Reviewer Guide, Angelo Tinazzi, Cytel Inc. CDISC-ITA-2020-Europe-re-mastering the define.xml and its brothers-Tinazzi.pdf
- Efficiently leveraging your RWD investment across the product life cycle, Stijn Rogiers, SAS CDISC Italian User Network 2020_Stijn Rogiers_RWE_Final.pdf
- Validation Rules and Validation Tools, Silvia Faini, Livanova 4_ItalianCDISC2020_ValidationRules_ValidationTools_Faini_updated.pdf
- CDISC SEND Data Standardization and Exploration, Marco Pergher, Aptuit 5_CDISC SEND oct2020 SIMEF v5.pdf
- News 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:
