|
So It’s Time to Write Your Thesis...
Before you begin Plan B (thesis with departmental review), please review the SDSU Thesis Template.
The Thesis Advisor will assist you with selecting and approving a topic. Before you contact the Thesis Advisor (dsevier@sciences.sdsu.edu), read the next few paragraphs to get an idea how to go about picking a topic.
Picking a topic
The two main guiding principles in choosing a thesis topic are 1) it must be related to Regulatory Affairs or Biomedical Quality Systems (depending on your degree program) in the pharmaceutical, biologics/biotechnology, medical device, or related industries (e.g., foods, dietary supplements, veterinary products, etc.) and 2) it certainly better be something you are interested in, if you are going to spend months researching it and writing about it! Maybe you already have a topic in mind, but if not, where do you start? Here are some sources of thesis topics:
Your job – What could be better than to work on a thesis that not only satisfied the requirement for your M.S. degree, but also was a significant benefit to the company you work for? Talk to the head of your regulatory affairs department or other appropriate supervisor about a potential topic.
Your RA/BQS courses – What topic that was discussed in one of your RA or BQS courses really piqued your interest, way beyond the level covered in class? Have you wanted to delve into that in greater depth “some day”? Well, that might just be your thesis topic. A variation of this is “the favorite instructor” approach; was there one of your RA or BQS instructors who was a favorite of yours? If so, you might wish to contact her or him and ask for their ideas for a thesis topic. Please remember that they are busy, working professionals, so respect their time, but as working professionals, they are also keenly aware of current regulatory activities and proposals.
The FDA – After all, what better source of a thesis topic could you find? What new FDA regulation, proposed regulation, guideline, guidance or other publication is either of interest to you, or will have a significant impact on your company? What are the details of that FDA action, and how should the industry respond and/or work to comply with this new regulatory challenge? Definitely sounds like a potential thesis topic!
The trade literature – Your everyday job brings you a variety of regulatory-related publications, from the Federal Register, to the Pink/Gray/Green Sheet, RAPS Focus, the DIA Journal, and many others. You are reading these to keep up with the ever-changing regulatory “playing field”, so why not use this to also look for a thesis topic? The editors of these publications have a knack for picking out the hot topics; so, use this as a source for a thesis topic.
Once you have an approved topic in mind, prepare a short outline of what your thesis might include. Typically, one part will be a short explanation on why you chose this topic, and why it is of importance to you and others. There is usually a short chapter on historical background, but do not take this as an opportunity to regurgitate everything you learned in your introductory RA/BQS courses! Keep it concise and focused on the significant background of your topic. You will want to include information on your research approach; this might be a literature search, personal consultation with experts in the field, even a survey. Then there is commonly a section on the results of your research, and finally there should be a closing section, which demonstrates your conclusions. This is the key element in the thesis; it must demonstrate your understanding of the topic, and provide the reader with your contribution to this topic. That can be in the form of recommendations on how to comply with a new regulation, a checklist on the subject to be used by the reader, or other ways in which you further the reader’s understanding and abilities in this area.
You will then send this outline to the Thesis Advisor of the Center for Bio/Pharmaceutical and Biodevice Development (CBBD). The two of you will then have some discussions about whether the Thesis Advisor thinks the scope of the topic is too broad or too narrow. Eventually, the two of you will agree upon your thesis topic.
Researching the subject
This is pretty much up to you. Just remember to be thorough, and maintain accurate documentation and references for each piece of research you do. Keep the University’s plagiarism rules in mind, and provide references for any quotes you use.
You have the opportunity to gain academic credit for your thesis research by enrolling in RA 797/BQS 797 – Research. You may enroll in this for 1 to 3 credits per semester, for a total of 6 credits. You will be charged the cost for taking this course, at the prevailing “per credit” rate. This is a “credit-no credit” course; you will not receive a letter grade in this course. While many of our students enroll in 797 as part of their degree program, some students would rather take another course to gain that additional knowledge, since they have to pay for a course. It is your option.
Beginning to write
This is where the “rubber hits the road” or the pencil hits the paper, or fingers start tapping on the keyboard. Before you start, we strongly recommend two things. First, review the SDSU Dissertation and Thesis Manual: Policies, Procedures and Format Edition 11.1. Second, visit the SDSU Thesis Template and download the thesis format style for Word. Once you install this into Microsoft Word ® you will, from the very first word of your thesis, be writing in the accepted SDSU format. Follow the SDSU style manual in all aspects, including charts, tables, figures, and appendices. Please note the following guidelines for signatures.
You are now ready to begin writing your thesis. This is one of those tasks that appears very much more daunting when looking from this perspective, than when you really get into it, and have finally finished it. I am reminded of a Dag Hammarskjöld quote, “Never measure the height of a mountain, until you have reached the top. Then you will see how low it was.” I believe you will remember this quote when you have your thesis done.
Thesis review procedure
It is extremely important and necessary to consult with Thesis Advisor as you begin the thesis process. Make sure you clearly understand how she or he wishes to review your progress. Decide whether the Thesis Advisor would rather see a few chapters at a time, or wait until you have a nearly final draft of the whole thesis to review. It is our policy that a minimum of two (2) weeks is required to review your complete thesis. Usually, we will provide you with comments, corrections and suggestions; it is your job to carefully review this advice and incorporate those you deem appropriate. Remember this is advice from professionals, but still advice and recommendations.
Thesis defense
Once you and the final draft of your thesis are ready, you will again submit a copy of the final version and your defense presentation to the Thesis Advisor. In the mean time, you will arrange a date, time and place for your oral thesis defense. The defense may be done as a teleconference.
At the defense, you will be asked to present your thesis, working from PowerPoint ® slides or equivalents. Your presentation should last 45-60 minutes, including questions. Focus on why you chose the topic, its relevance to current RA/BQS issues, your approach to your research, your findings, and finally, and importantly, your contribution/ conclusions. Be prepared for questions.
At the end of your presentation, and answering of questions, you may be asked to leave the room while the committee members discuss your thesis and presentation. You will be asked to return, and hopefully the committee will congratulate you on your success. This may be accompanied with some last-minute corrections, or minor suggestions for improving your thesis prior to final submission. On rare occasions, the committee has recommended significant changes to the thesis, and requested to see the final, revised thesis prior to approval.
You should have ready, at the time of your oral defense, two or three copies of the signature page of your thesis. Please make sure your signature page is formatted properly before your defense. Upon approval, each committee member will sign this page for your inclusion in the original copy of your thesis.
The final steps
You will take your thesis to Montezuma Publishing for reproduction and binding. The CBBD requires one copy of your thesis, in appropriate library binding. You can, at the same time, order a copy for yourself, and anybody else you wish. You have a choice of less costly binding for personal copies. You are responsible for the cost of all these copies, including the CBBD department copy. You may view the current online price sheet or pick up a copy from the Graduate Division or Thesis Review Service. For students outside of the San Diego area, the CBBD staff can assist in coordinating these final thesis submission steps, including graduation activities.
|
