Why Download this Case Study?
Adverse events which occur during the course of clinical trials must be appropriately identified, recorded and reported to ensure continuing patient safety and the quality, accuracy and integrity of trial data.
Failure to correctly identify non-serious and serious adverse events, and deal with them adequately, while also following the required reporting procedures, can have significant implications on clinical research and regulatory submissions. A pharmaceutical sponsor had specific concerns about some investigative sites involved in a phase III study in infectious disease.
To validate the sponsor’s concerns, the company implemented CluePoints' Central Statistical Monitoring solution to provide an overview of data issues across all sites involved in the trial.
Download this case study to discover how CluePoints detected that the investigative sites were mis-classifying different types of Adverse Events.
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