Training and Data Management Clause Samples

Training and Data Management. Measures specific to Investigator training and safety data management will be implemented as follows: • Investigator and site personnel training will include a focused review of expectations for monitoring safety and implementing risk mitigation. • Study data will be captured in real time using an EDC system, allowing for routine review of EDC data by the Sponsor’s Medical Monitor and clinical team, independent of the timing of on-site monitoring review. • Routine on-site review of study records and data by the Sponsor’s monitoring affiliate will begin directly after the first patient is treated at each study center. • A central clinical laboratory will be used for hematology, serum chemistry, and urinalysis to provide standardization across study centers, rapid on-line access to results, and customized alerts for results requiring exclusion/discontinuation, thereby allowing Investigators as well as the Sponsor’s Medical Monitor to identify potential safety issues early; standardized reference ranges for each test will be provided on every report of results and will also be available in the laboratory manual.‌‌‌‌ • A core cardiovascular laboratory will be used to provide standardization in ECG collection and interpretation across study centers, with rapid on-line access to results and customized alerts for exclusion/discontinuation. • SAE reports and associated data will be reviewed on an expedited basis by the Sponsor and its affiliates in order to meet reporting obligations and implement additional risk mitigation (if applicable).