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So It’s Time to Write Your Thesis...
The Graduate Division website provides a comprehensive look at the thesis process and also provides vital information regarding applying for graduation, thesis submission deadlines and thesis formatting. Before you begin the thesis process, 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.
If you still need help thinking of a topic after exhausting these resources, you may contact your Thesis Advisor at the Center for Bio/Pharmaceutical and Biodevice Development (CBBD).
Once you have a 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 your Thesis Advisor. The two of you will then have some discussions about whether this topic has possibly already been done by another student, or whether your 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.
Picking a thesis committee
Your thesis committee will consist of a minimum of three individuals. The chair of your committee must be a tenured or tenure-track SDSU “department” member. That currently limits your choice Professor Dale Sevier. A second person on your committee should be another tenured/tenure-track professor from SDSU. Your thesis committee chair or thesis advisor will likely have some recommendations. The final person on your committee can be an instructor from one of your RA or BQS classes, regardless of whether he/she has a tenured/tenure-track appointment at SDSU.
Your thesis committee may optionally include up to two additional members. If someone at your company helped you choose this topic, or provided some significant guidance in your research on this thesis, you might consider asking them if they would like to serve on your committee, if you wish.
It is now your responsibility to contact each of the selected potential committee members to gain their agreement to serve on your committee. Again, one must remember that each of them is a busy professional, and reading your thesis and attending your oral thesis defense is a commitment of their valuable time. So do not be offended if they honestly state that they are too busy to do this. Move on to another worthy person.
Once you have agreement from your committee members, you will need to circulate the Appointment of Thesis/Project Committee form to obtain their signatures. You and your committee chair will also need to sign the Rights to Thesis/Dissertation Data and Publication Authorship form. We can assist you in submitting the forms to the SDSU Graduate Office. You can obtain both forms through the Graduate Division by calling 619-594-5213.
Enrolling in RA 799A / BQS 799A
You will be allowed to register in RA 799A/BQS 799A after you have: (1) attained classified status, (2) submitted and received approval of an official Program of Study, (3) been advanced to candidacy, and (4) received approval from the Graduate Division of your Appointment of Thesis/Project Committee Form. If you are unclear as to whether you have met each of the criteria listed above please contact the CBBD staff for clarification. The Appointment of Thesis/Project Committee Form must be complete and signed by all members of the proposed committee and the Graduate Advisor. Please sign up for 799A only when you are confident that you will complete your project during the semester in which you are enrolled. Keep in mind that it generally takes 6-9 months for students to complete the thesis process.
If you are unable to submit your thesis to the Thesis Reviewer during the semester in which you are enrolled in 799A, you will need to enroll in Thesis Extension 799B the following semester(s) until you complete and submit your thesis to the Thesis Reviewer. Thesis Extension 799B enrollment forms are available through the Graduate Division, 619-594-5213. You must be enrolled in 799A or Thesis Extension 799B during the semester in which the thesis is turned in to Thesis Review and during all semesters that you are consulting with faculty or using campus facilities.
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 be prepared to 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 in total. 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. While it is about as interesting as that last CFR section you read, it is about equally as important. 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. This will likely allow you to avoid the cost of someone else reformatting your thesis. 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 your thesis advisor as you begin the thesis process. Make sure you clearly understand how she or he wishes to review your progress. Decide whether your 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. Once your thesis advisor agrees that your draft thesis is ready, it is your responsibility to provide each committee member with an electronic copy for his or her review. It is our policy that each committee member is given a minimum of two (2) weeks to review your thesis. Usually, each committee member 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 this final version to each of your committee members. In the mean time, you will arrange a date, time and place for your oral thesis defense. If you intend to attend SDSU graduation exercises, you will have to work closely with the CBBD staff and adhere to the appropriate SDSU deadlines for submission of your final thesis. This entails careful planning of those critical steps leading up to final thesis submission, including time for thesis review, oral defense, and final corrections of the thesis. This is an appropriate point at which to divide this guidance into two sections, one for students living in the San Diego area, and the other for our students outside the local area.
San Diego area students have the option of holding their thesis defense on the SDSU campus, or elsewhere, possibly at their work site. You are responsible for contacting committee members to gain agreement on the date, time and place for your defense. Confirm this final information with all committee members and with the CBBD department staff. It is a good idea to send each committee member a reminder a few days prior to the actual defense. If the thesis defense location is off-campus, you should offer to provide a map and/or directions to the location. You will also be responsible for assuring that appropriate computer, projector and other equipment will be available for your use.
At the defense, you will be asked to present your thesis, working from PowerPoint ® slides or equivalents. (Note that the presentation should be reviewed in advance by your Thesis Advisor.) Provide each committee member with an electronic copy of your slides several days in advance of your presentation. Your presentation will be expected to 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.
For students outside of the San Diego area, the process is much the same as described above, but the oral defense will not be face-to-face. You will still need to arrange a mutually agreeable date and time for the defense. Your thesis committee will meet on the SDSU campus in front of a speaker telephone, and you will be at the other end of the telephone, at home or in your office. You will need to provide your committee chair with an electronic copy of your PowerPoint slides. You will also need to arrange to have 2-3 copies of your signature page ready for use; the CBBD staff can assist in this. Please make sure your signature page is formatted properly before your defense. Your committee chair will provide you with a telephone number to use for your thesis defense.
The oral presentation will proceed as if everyone was together in a conference room, with the exception that you will need to alert the committee when you are going to your next slide. Again anticipate questions, during your presentation and at the end. Instead of leaving the room, the committee may put you “on hold” by pressing a mute button, during their brief deliberation. The anticipated congratulations will not include the usual handshakes, but will be just as wholeheartedly offered to the successful student. The CBBD staff will assist in bringing the completed signature page and your final thesis together.
Submitting your thesis to the University
This, of course, involves another form, the Thesis Clearance Sheet. Graduate Division staff will prepare a Clearance Sheet that will be placed with your manuscript and submitted to the Dissertation and Thesis Reviewer. You will be asked to provide computer software you used to write your thesis, and the reference style you used in your thesis. Our department does not require a specific referencing style, like some departments do, but require that you use a recognized one, and use it consistently. For students outside our local area, our staff can assist you in delivering your final thesis to the SDSU Graduate Office.
The final steps
One individual reviews each and every thesis submitted to SDSU, thus the need for deadlines! The Graduate Office will deliver your thesis to the reviewer, who will carefully go over your thesis, looking primarily for adherence to SDSU formatting requirements. That individual may also find some minor typographical errors or other mistakes. Upon completion of your thesis review, this reviewer will contact you with any additional corrections that are needed prior to final submission. For students outside of San Diego, this will be done via email or phone. It is your responsibility to make all final corrections and obtain the final “signoff” of this reviewer.
The thesis reviewer will take your thesis to Montezuma Publishing for reproduction and binding. The student must call Montezuma Publishing to place the order and make payment arrangements for copies for the SDSU Library and for our department. The SDSU Library will receive and shelve one copy of your thesis, in appropriate library binding, and our department will receive a copy for our department shelves, in the same 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. These copies will be mailed directly to you. You are responsible for the cost of all these copies, including the SDSU Library and 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.
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