Title: SDV in Risk Based Monitoring, including quantitative experience
Presenter: Rich Davies
Organisation: OmniComm Systems, Inc
The industry has been adopting Risk Based Monitoring for several years and there has been much information shared as to what will be the impact and change to historical ways of working. One such area is the process of Source Data Verification. What does a theoretical SDV target look like in an RBM world? This presentation re-examines the value and options for setting SDV targets on RBM trials before looking at data obtained from a selection of clinical trials that changed SDV practices in response to RBM.
Learning Objective 1: What are the drivers for SDV and what could reduced SDV targets look like ?
Learning Objective 2: From a selection of RBM trials, what was the SDV coverage in practice ?
Learning Objective 3: Where is SDV supplemented by other processes and technologies ?