This course is designed to present an introduction to the global regulations governing the conduct of clinical trials and for regulatory approval of a new biologic, medical device, or pharmaceutical product. The student will be introduced to EMA, FDA & ICH regulations and standards, regulatory violations documented in warning letters, clinical roles and responsibilities, as well as the IRB/IEC process, and key study documents and principles of clinical study management.
- Appraise the key elements of GCPs and the equivalent elements contained in the ICH guidelines for the conduct of human clinical trials.
- Contrast the key clinical trial conduct responsibilities that apply to a study sponsor, an IRB, and a study investigator.
- Examine the key steps chronologically for the set up and operation of a clinical trial.
- Select the essential documents required to conduct a clinical trial.
- Evaluate the key sections of a basic study protocol and informed consent form.
- Design a clinical study report summarizing clinical trial results.
- Assemble key FDA nomenclature pertaining to Good Clinical Practice Regulations.
Recommended: Prior completion of
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