RAS631

Explain how and when clinical trial regulations are applied.

Identify and interpret FDA investigational device exemption regulations, guidance documents, standards, and reporting requirements.

Describe the principles of scientific design, the process of writing clinical study objectives and endpoints, the methods of determining sample sizes and performing statistical analysis, and common methods for collection and analysis of clinical data.

Identify and formulate advice on ethical research practice and conduct to protect human subjects.

Discuss the process phases of a clinical trial and basic clinical paradigms commonly used to determine safety and effectiveness/efficacy.

Describe the submissions to support pre- and postmarket clinical trials.

Identify strategies to communicate and report negative product-performance situations.

Define maintenance activities, the post-trial approval process and content.