Report from the first Italian User Group Meeting

November 16th 2007, Milan

The first Italian CDISC User Group Meeting has been a great success with a total of 80 participants representing pharmaceutical companies, CROs, clinical software vendors,

research and academic institutions (two pharmaceutical companies and one CRO from Switzerland).Clinical data managers and biostatisticians were equally represented. SAS programmers and project manager were present as well.

The meeting was organized and offered by Helsinn Healthcare (Lugano, Switzerland).

The meeting opened with Annamaria Muraro, coordinator of the Italian CDISC User Group, welcoming the attendees, thanking the italian associations that contributed to advertise the event (BIAS, Biostatistician Italian Association and SSFA, Society for Applied Pharmacological Sciences) and introducing the E3C guests and the speakers.Simona Parisi (Helsinn) wished a useful and pleasant event to everyone.

Tim Jaeger gave a short overview about CDISC and Ann-Sofie Bergström made clear the benefits of standards and gave an overview and status of the current User Networks.

The meeting had a very busy agenda. Several presentations were held with the purpose to provide a basic overview about CDISC projects and standards already developed:

  • Introduction to CDISC, Wolfang Summa, E3C, Invivodata
  • Study Data Tabulation Model – Annamaria Muraro, Helsinn
  • Controlled Terminology – Cecilia Moresino, Helsinn
  • Implementation of SDTM in Oracle Clinical – Paolo Morelli, CROS
  • CDASH Project – Isabella Montagna, GBPharma
  • Introduction to ADaM – Annamaria Muraro, Helsinn
  • Introduction to ODM, Philippe Verplancke, XClinical, Munich.
  • CDISC, Bridge and other projects, Udo Siegmann, E3C, Parexel Berlin

Lunch was held to a great terrace with a wonderful view to the centre of Milan and provided an opportunity to meet friends, share thoughts and provide feedback.

Few questions were asked during the presentations. Questions were asked in regard to CDISC and EMEA collaboration, others were raised with respect to terminology, the CDASH project, HL7 standards and implementation questions in general.

Annamaria Muraro proposed to have a face to face meeting once a year and several educational events during the next year. The next meeting was not scheduled yet.

A short questionnaire was distributed collecting questions about training and topics the participants are interested most, previous experience about CDISC implementation, evaluation about the first meeting and free comments/suggestions. This is a short feedback from the questionnaire:

a)participants would like to be involved into future UG activity

b)almost all participants are interested on performing training about SDTM, ADaM and ODM

c)case studies is the most interested topic suggested for future events

d)very few has already an expertise about CDISC

e)the meeting content and the arrangement were very appreciated.

Someone was interested about CDISC and medical devices. Someone proposed to organize sub-teams to work on SDTM implementation by therapeutic area (oncology).

The meeting was followed with enthusiasm by the attendees, was productiveand has to be considered a good starting for future activities of the Italian Speaking User Group.

Annamaria Muraro