Our Clinical Events Committee (CEC) team has been adjudicating events for years and has created processes that have been adopted by many other AROs and CROs. Our operational model integrates an evaluation of the quality and consistency of adjudication results.
The following describes an internal quality control process for adjudication that we piloted on a study involving an implantable valve device for treatment of heart failure, which works in the following way. Internal clinicaland operations team members pulled a random sampling of 150 adjudicated results from a pool of 3,500 completed events and re-submitted them for adjudication in a blinded fashion. All critical and non-critical variables were established using protocol-defined endpoints. The results were analyzed internally by our clinical team. The blinded adjudication results were then compared with the original rulings to determine their consistency.
The comparison and analysis revealed an acceptable critical variable rate. As a result, this quality process was and continues to be implemented for all new clinical studies using specified criteria after internal evaluation.