Regulatory Compliance and Research Ethics

Describe Good Clinical Practices (GCP) of the FDA along with an introduction to international clinical regulations.

Articulate the regulatory requirements associated with the clinical evaluation of unapproved and approved medical devices in humans.

Describe how and when FDA regulations are applied in clinical research and the importance of regulatory compliance.

Identify and interpret IDE regulations and guidance documents or standards that are applied in clinical research

Define study objectives for multiple audiences (FDA, Centers for Medicare and Medicaid Services (CMS), physicians and patients) and analyze/interpret statistical considerations associated with designing a clinical trial.

Describe what clinical reports are required and what clinical data needs to be reported; Define the maintenance activities for an IDE and the post-trial approval process and content.

Cite and synthesize historical events and examples of human rights violations that lead to the development of research ethics, regulations, and standards for protecting human subjects to advise study teams on expectations for the conduct of ethical clinical studies according to international standards.

Describe the pre-trial submission process including pre-IDE meetings and IDE application contents.

(RAS) Describe the principles of experimental design, sample size estimation, and statistical analysis methods to use in clinical trial protocols, using mathematical and computational thinking.

Describe the approval process for International Clinical Trials.