We’ve previously blogged about, and presented in various forums, a compelling industry benchmark that reveals the very small impact that site monitoring and source document verification (SDV)—along with other sponsor data reviews—has on the electronic case report form (eCRF) data provided by investigative sites during clinical trials.
Over the past year and a half we’ve been monitoring the trend towards adoption of risk-based monitoring across the industry, with particular interest in evidence of broader adoption following the FDA draft guidance and EMA reflection paper, both issued in 2011. Given the clear endorsements for this paradigm reflected in these documents, we are anticipating an inflection point towards broader adoption.
Some queries are more equal than others! Those of you familiar with George Orwell’s “Animal Farm” may recognize this paradoxical declaration. The queries I refer to here are the "questions" sent back to investigative sites to clarify clinical data that they have provided to the sponsor during a research trial.
Geeks Talk Clinical contributor—often exhorts his fellow “Medidatians” to not simply work hard, but most importantly to work smart. While I’m sure he fully expects that we will continue to work with the same high level of passion as before, what he really wants is for us to seek out opportunities to increase the impact of our collective efforts.