We learned about many different project design documents that are needed to produce a product in industry. I am curious to know what the equivalent of these documents is if working in academia. For research, you need an experimental protocol. This is analogous to a Design Controls Document. What are some other equivalents that you can reason? Documentation is still needed for a research project in an academic laboratory. Going from idea to publication is very similar to the project life cycle.
From my experience in clinical research, one such document required by the FDA is an IRB, Institutional Review Board. This document is necessary to protect the welfare and rights of human subjects by ensuring that your experiment will not harm those involved. This is the very first step in running an experiment and needs to be approved before you can start.
I will elaborate a little on IRB, because that documentation is the most important aspect of research in academia. The IRB reviews any ethical concerns of a research experiment. If they approve the study, that documentation then has to be posted in easily view-able location where the study will be taking place. The IRB would contain aspects of industrial documents such as the project proposal, DDP, DSD, etc. All of these things are in it because they need to be checked and approved by the board.
When working in research one must have a lab notebook to document ones findings. There is not many rules to this living document however it should be clear and concise what you are doing for each experiment and/or discovery that you find. The document is also a reference to previous successes and problems you had in the past. I am sure if you had an issue with lab equipment or some mechanical failure one might have wrote the variables that may or may not have caused it. For example , I worked with an electro spinner. One day I wondered why I could not get fibers to spin. I looked in my lab notebook and noticed that humidity helped in the processing of forming fibers, in general. Wouldn’t you know, once I added humidity I was able to get fibers. Therefore, the lab notebook is critical.
In research, documentation is also very important. Besides protocols, laboratory notebooks are highly useful because here it's where you can find specifications of a procedure or a concept that can help people understand or have more efficient results. When I worked in research, I was given a laboratory notebook and was told to document any interesting results, as well as raising questions, or something that caught my attention. I used the notebook every day, I will take notes of procedures that were new to me, and this helped me remember the steps easier, as well as other aspects that will avoid mistakes. When I was doing chemical assays, I wrote in the notebooks the steps I needed to take, and at what conditions they were taken, so the next time I could review, or redo if necessary.
From my experience in research, we did also document a lot and were very specific. But we didn't have anyone inspecting us or our documents, we did it for the sake of honest data that was needed for publication. When publishing, we need unbiased and true data, so we recorded anything and everything we can. We also needed to show that we knew what we were doing so we used protocols and procedures that were proved to work by previous publications. This strengthened the claims of our study. So although, we don't have the same style of documentations as in industry, we followed strict written procedures and guidelines, we also recorded our procedures well so it could be repeated. So in academia, there is a lot of documentation as well, all for the sake of a good publication.
Having conducting a bit of research, the closest thing to design documents are definitely what is written in your lab notebook. The research that I did involved many custom built parts, so there were many sketches and notes on design iterations in my lab notebook. But it was very different as there was no one really reviewing them. They were mostly for documenting what I did so I could go back and look at my thought process, as well as a good way to show how the design evolved over time. I never wrote a paper on what I was researching, but if I wanted to or someone wanted to in the future, then the notebook would a great place to pick up from where I left off.
When working in research, there is no standard design document when conducting an experiment as experiments are always subject to change. Let's take coming up with a new formulation for a hydrogel for example. Once we come up with an idea on what ingredients would be needed, we test out the formula. While conducting this experiment, it is imperative to have a lab journal on you at all times, documenting your observations. If the hydrogel is not up to par, taking your observations, you create a new formula with addition of ingredients and adjusted quantities. This new formula is now the updated formula. Most researchers have multiple drafts of their formula's and compile it into one document, showing the evolution of this hydrogel, acting almost like a DHF.
While working on research you must have lab manual. This document should be clear and concise in format for experiments. It would help as a reference for success and problems that might occur in future and past. Anyway in research documentation is very important. Here is the document that has all the specifications of a project and a device to understand. It makes the work easier by taking notes of steps and procedure. This helps alot in avoiding mistakes.
Most of the responses mention documentation in academia being things like lab manuals and lab notes. But if the research being done in academia is being used to develop some type of new medical device, would it be required to follow the design controls process even if the entire development is remaining within academia?
I believe this article explains the expanding role academia now has on the medical device development process, as shown in this picture below. This "paradigm shift" explains that the role of academia in recent years has taken on more responsibility of development steps not typically associated with them such as prototyping and clinical safety testing. This "shift" is occurring during a crucial phase of development where licenses issued are now done during clinical trials, well after the prototyping phase, where the device design has been more well-established. This gives more leverage to universities to handle the development of these devices with more scrutiny, but it also adds a new level of challenge for universities to take more charge of their own ideas that may have been previously handled by private companies. Companies may still handle the end product for commercialization, but they are more or less handed over a finished product. 
From my experience, the IRB document is what you want. The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
As a MS student working in research right now, from my short experience, the IRB is in charge of reviewing all research protocols. Whatever test is being run in the lab, the IRB is the ruling factor in deciding if it is safe to the rights and health of the subjects that will partake in the study. The lead researcher is in charge of following the guidelines set by the IRB and overseeing that the study follows the rules that the IRB decides when the project is proposed.
In all honesty, I think it depends on the nature of your research. If you are working with animals or humans then comparative documents would be IRB approval and approval from animal review boards.
If you view it from a more, "holistic" standpoint, then I suppose you could count on reviewing your experimental plan with your PI as a part of the verification phase. It really depends on what you are researching, designing, and trying to make. If you are making a product in an academic lab, then the verification steps discussed in this chapter are probably necessary for getting approval for the product even if it was made in an academic setting.
@sts27 I agree, in my opinion, I do think in academia different departments have different regulations. For example, I do believe the life sciences department could have different regulations than the engineering department. An example of regulation needed for engineering devices could be filling out an IRB form for the project to establish the rights of the project.
