Overview of the Clinical Research Process

Clinical research is the testing of experimental drugs, biologics, and medical devices in humans. This course describes the clinical research process for those who are involved in any aspect of the development, research, marketing, or sales of new drugs, biologics, and devices. Topics in this course include: Regulations, GCP, Documents, Phases, Timelines and Costs, and Final Stages. After completing this course, learners will be able to recognize the nonclinical and clinical components of new product development.

After this course learners will be able to identify what is entailed in the research process for new drug, biologic, and device products, including the documents submitted in order to gain marketing approval. recognize the nonclinical and clinical components of new product development. identify the importance of the us code of federal regulations (cfr), european union (eu) directives/regulations, and the international conference on harmonisation (ich) guidelines and ways good clinical practices (gcps) are reflected in each of these documents.