C05 – Technology and the Changing Process of Monitoring

A risk-based monitoring (RBM) perspective:

–          Background and current status

–          ICH E6 R2 – additional provisions and expectations for monitoring trials

–          Benefits and challenges (including change management)

New approaches using technology – the opportunities, risk identification and mitigation practicalities of applying it in the real world:

– recruitment strategies – now and in the future

– eConsent

– Regional site clinical trial participation

– electronic source documentation- Future potential for innovative trial designs

Chairperson: Luke Edington, Clinical Projects & BDDatapharm