The NIH has recently revised existing case studies and added a few new ones to help clarify how the definition of clinical trial does or does not apply to a variety of clinical research studies. They have also added two new FAQs on standard clinical care and Phase 1 devices.
Additionally, to help you quickly find the case studies that are most relevant to your research, NIH has added the ability to filter the case studies by keyword.
To see the NIH definition of a clinical trial and review the case studies, go to grants.nih.gov/policy/clinical-trials/case-studies.htm
ref: NIH: Jan 4 Open Mike