How to track your e-CRF to provide the data needed 
at pre-defined timepoints

Franziska Falk - Astellas Pharma Europe Ltd.

This presentation will address the role of EDC in adaptive trials. Timely data capture and cleaning are a pre-requisite for adaptive decisions in an ongoing trial. In order to enable strategic decisions on trial designs during a trial, at a certain point critical trial data must be present. Several tools to support and facilitate the timely data capture and cleaning process in trials conducted with e-CRFs will be discussed: proper planning of data cleaning steps, the information delivery portal as a tool to supervise data entry and medical consistency, multiple blind data review meetings and strategies to encourage sites to enter the data in time.