Ethical And Regulatory Considerations

This section is required by some but not all regulatory agencies and its form and content will depend on which branch of the regulatory agency is responsible for supervising your trials. Analogous to the preceding section, it consists of a listing of your company's responsibilities with respect to the patients, the investigators, and the regulatory agency. It is a form of contract (as is the entire submission) and you as the manager are responsible for seeing that its pledges are honored.

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