ACR628

Describe good clinical practices (GCPs) of the U.S. Food and Drug Administration (FDA) and the basics of international clinical regulations.

Articulate the regulatory requirements associated with the clinical evaluation of investigational and market-approved medical therapies in humans.

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

Interpret 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).

Analyze statistical considerations associated with designing a clinical trial.

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.

Advise study teams on expectations for the conduct of ethical clinical studies according to international standards.

Describe the clinical reports and the clinical data that must be reported to the FDA.

Describe the pre-trial submission process, including pre-Investigational Device Exemption/Investigational New Drug (IDE/IND) meetings and the IDE/IND application contents.

Define the maintenance activities for an IDE/IND, the post-trial Pre-Market Application/New Drug Application (PMA/NDA) submission process, and the associated contents.

Describe the approval process for international clinical trials.