Overseeing and Monitoring Safety

Database Manager The database manager functions under the guidance of, but independently from, the Principle Investigator. One model for this function is the data safety and monitoring committees appointed to oversee the progress of clinical trials (6). 

The PSM Task Force will oversee the pilot throughout its duration, monitor its progress, and develop recommendations for improvement. Individual task force members will actively participate in the pilot test, to support Ray s managerial responsibilities and to provide specific input as needed. The Task Force reports to the division s Vice President—Environmental, Health, and Safety. 

In protecting the scientific integrity of the trial the DMC must ensure that all interim analyses and safety monitoring activities are conducted in an appropriate way to protect blinding and the type I error to avoid problems with multiplicity. There is also the responsibility to oversee the overall conduct of the trial to make sure that it will fulfil its objectives. 

To ensure safety, the FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit the results Continued on next page)... 

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