Multicentre observational trial

Tue, 01/09/2009 - 12:35pm -- Ludwig Everaert

In support of the revision of the reimbursement criteria of a product reimbursed in Class I, we designed and launched a retrospective multicentre observational trial.

  • The project was started in September 2009 by writing the protocol and desiging the basic Case Record Form.
  • Approval was given by the client in February 2010.
  • EC approval obtained May 2010 and data collection started immediately thereafter.
  • Data collection was complete early July 2010  (data of nearly 90% of the total patient population).
  • Analysis was done and the report was available before the 31 August 2010 deadline.