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

I am currently doing capstone 2 at NJIT, we definitely do the testing of our design but we do not make the clinical trial Protocol. My project is to make the control cortical Impact device which is used to make an traumatic brain injury on the rat. So in this project we have created the test plan to test hardware and software requirements and we also have to perform the demo of our device to show that it working but we are not allowed to do it on real rat. We do the IRB approval document as an assignment for the class but we do not do not submit it. And we also do the assignment to classify our device in terms of class 1, class 2 or class 3 but as I said it is an assignment so we do not go to a complex level that we have to fill out the 510(k) or executed the clinical trial protocol.

I did my Bachelors at Long Island University, Brooklyn where I did subject based research. while devices were used, the purpose was to test the effects of the activity on the subjects rather than the efficacy of a device. many, if not all, of the steps covered in the lecture will be apart of any academic subject based research. The protocols will vary as necessary depending on what type of device or effect is being researched, however the methods will include similar steps. ICH Guidlines are considered, IRB's are necessary, etc. this is why i stated in one of the other threads that a background in research should be more important than a clinical background for eligibility for a CRA position. while i have not conducted clinical trials for a company, the environment, ethical, validity requirements, seem very similar if not the same.

When I worked o nay undergraduate capstone project in order to get approval to do testing on human subjects we needed to fill out IRB application and present the project and test cases involving the use of human subjects to NJIT's IRB and it was up to them whether or not to allow someone to go further with human testing. Given the risks of human testing an IRB is very risk-averse and obtaining approval to use human subjects to test an undergraduate research project they require a lot of evidence that a device will offer no potential harm to any subjects

I think it is very complicated to get IRB approval for a clinical trial where the outcome is unknown. The IRB wants to make sure that a device will offer no potential harm to any subjects, and this is a case where the outcome is unknown and the researcher can't be sure that no harm will be done. Thus this is not a likely area for students to study. Such an IRB would more likely be obtained by a hospital or device company that has more structures in place to support such research. Also this type of research takes a very long time to conduct.

I did my undergraduate in electronics and computer engineering and minor in biomedical, For our graduation project was much focus on research and documentation for the first course and the second course was focused on implementing the idea. For my project, I have created a platform to capture all the reading from devices like EEG, blood pressure, weight, ....etc and generate an electronic version on the server for the doctor. So, Given my background, the professor focused more on the software capability and solution in general. after learning about devise classes, I think my project would be considered as a class1 and would not need clinical trial but, I would like to read more in this post to learn about more biomedical technical devices.

While I was completing undergraduate research at NJIT, I assisted with starting a new study using Functional near-infrared spectroscopy (fNIRS) as an imaging technique. The investigators completed the IRB application and received IRB approval, though I was not involved in this process and do not know the details it. In addition to IRB approval, everyone assisting with the study completed an online training to receive Human Subject Assurance certifications. 

We had to do clinical trials in the Capstone Project I was involved. Our project focused on designing a toothbrush that would help with saliva collection. Our group already had IRB approval since we had taken on a project that was worked on in the previous semester. In our process, we had to change the names of the people currently working on the project to our names and then find a suitable place to conduct the study. While our advisor conducted the study, we helped them collect data and keep the work area organized as we weren't allowed to interact with any sample collection. Afterward, the collected data was reorganized to fit in with the scope of our project.

Clinical trials are expensive as well as time-consuming, so reducing a device to a semester is a very tough task to do and is impossible. In the capstone class, students are working together to get primarily a grade in the course as well as showcase their skills, which is very different from clinical trials, which are more financially motivated and require years of expertise to complete. Working together on this class is most likely the best way to simulate industry experience without getting into the industry because of the multiple pathways an engineer can head down. Most people won't even have to encounter clinical trials, which is why clinical trials are not prioritized as much in the capstone course. In the type of industry I've worked in, there aren't clinical trials, but something similar can be created when the company conducts research and works on multiple trials to determine the best way to formulate the product. In the clinical trial, you are working with different people, such as the investigator, sponsor, who can be likened to the chemist, and manager, who are working on the product and running through multiple trials to work toward the goal of creating a new product.