Q&A Competencies

Quality Assurance

Many of the quality control measures of the lab are described in the specified sections such as training, equipment and data management. The Core Lab has a 100 percent quality control process. All studies are initially analyzed by a trained technician/sonographer and are then reviewed by a board certified cardiologist to ensure accuracy.

The Core Lab will work with sponsors to identify the elements that should be checked during the quality assurance process and will develop and document a process to meet these quality control measures.

Competencies

All Core Lab staff is oriented [familiarized?] to the lab using a standardized three to six month training process. The training includes a review of the computer systems used for analysis as well as electronic case report forms and database formulation. To complete training, all technicians must successfully perform measurements and calculations on several cases, which are reviewed by the Director of the Laboratories and a fellow technician, and must meet pre-specified inter-observer variability standards. Prior to initiation of a study, all personnel are trained on that study including review of the protocol and Core Lab analysis required for that protocol. All aspects of training are documented for each employee.