A9 – Data Management Considerations for Investigator Initiated Studies

This session will explore the data management of investigator initiated studies from the following perspectives  (1) What can be done in the planning stages of a project to set in place robust, easy – to –use data management procedures. You will step through points to consider when planning to share sensitive research data, as a research output ( 2) Protocol and CRF design in investigator initiated studies and what to do with the data produced and (3) The consequences and impact on the successful completion of the study and future interactions with regulatory agencies when an interim analysis is performed outside the protocol specified time points.

Chairperson: Sue Mason, ARCS Australia