Common use of DATA CONTROL MEASURES Clause in Contracts

DATA CONTROL MEASURES. In order to assure adequate control and provide study data that are consistent and of the highest quality, the following measures are employed: 1. Each clinical procedure (i.e. physical examination) for a particular patient is conducted by the same person if possible throughout the patient's study participation. 2. Each clinical laboratory procedure is conducted by the same laboratory throughout the study. 3. Data generated automatically is reviewed by the appropriate specialist, i.e. computer generated EKG interpretation is reviewed and signed off by a cardiologist.