I completed my undergraduate degree at NJIT as a biomedical engineering student, the course you are referring to does not necessarily relate to clinical trials. Within capstone, we do experiments on our design, but we never went to the extent of making a protocol or following ICH Good Clinical Practice guidelines. Within capstone, we had to make a requirements document and final report for the product we were designing. The final report consisted of our test results for each requirement. However, we did not classify our product in terms of a class I, class II or class III device. We never went to the extent of completing a 510 (k) to organizing clinical trial guidance documents. At work I have seen the documentation of protocols but not clinical trial documentation. The FDA requirements for clinical trials must be thoroughly documented and approved.

References:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm122046.htm