Angelo Tinazzi, Director, Clinical Data Standard and Data Submission, Cytel, Inc.

“Esempi pratici di Implementazione dello standard CDISC-ADaM” (Practical Examples of CDISC ADaM Implementation)

About 45 professionals from various Italian pharmaceutical companies and CROs attended the 5th Italian CDISC User Group 27 October 2017 at the University of Milano-Bicocca in collaboration with BIAS (Biometrics Italian Association). Five students from the local statistical faculty also attended the event.

The meeting was dedicated to the use and implementation of the ADaM standard. Coordinated by Silvia Faini of CROS-NT and Angelo Tinazzi of Cytel Inc., both members of the European CDISC Committee (E3C), Angelo began the meeting with a summary of the main characteristics of the CDISC Foundational Standards (with focus to submission requirements) and current CDISC initiatives. Silvia then introduced ADaM and its principles. Antonio Valenti from CROS-NT provided tips and tricks to avoid bad interpretation of the ADaM standard. Alessia Sacco from Valos completed the morning session with a presentation on how her company is creating define.xml using Pinnacle21 community version and SAS.

In the afternoon, Valerio Romolini and Gabriele Filippo Di Domenico from GSK Vaccines and Angelo Tinazzi presented practical implementation of ADaM in two distinct therapeutic areas, Vaccines and Oncology. Although it was not intended to be an ADaM training, Silvia and Angelo went through the main ADaM principles by using real-world examples making sure the key messages were well understood by the audience.

The Italian CDISC User Group holds quarterly teleconferences, in addition to the annual face-to-face event. Participants were invited to bring ideas and topics to discuss for the next events. Some of the most recent topics discussed by other European User Groups were also quickly introduced as an example.

We would like to thank Società di Scienze Farmacologiche Applicate (SSFA) for the logistics support and Cytel for sponsoring the event to celebrate their 30 years of activity.

For detailed information please see the slides used during the event, which have been uploaded into the Italian User Group Portal.

University of Milano-Bicocca
CDISC Italian User Group