Clinical Research Training Program

Thesis Requirements

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Goals of the Thesis

The Thesis is the capstone of the CRTP and the M.S. degree. The Clinical Research Training Program is designed to combine didactic classroom learning with a hands-on, mentored research experience; the Thesis is the culmination of that experience. By successfully defending the Thesis, each Scholar can demonstrate mastery of the knowledge and skills required to do clinical research.

 

General Requirements

The Thesis must represent the Scholar’s own work. While clinical research is by its nature collaborative, the Scholar must be the leader of the research team. If the Thesis is written as a grant application, the Scholar's contribution must be that of the Principal Investigator. If the Thesis is written as a manuscript, the Scholar's contribution must be that of the first author.

The Thesis project must involve data collection, or an original analysis of existing data. In the event that sufficient data cannot be collected to support a complete data analysis, as in a journal manuscript, it should be used as pilot data for a research proposal.

The Thesis project should be hypothesis-driven (e.g., Phase I drug studies are not acceptable).

The Thesis must be a clinical research project, as defined by the NIH Director’s Panel on Clinical Research 

 

Thesis Format

The thesis should be a manuscript as would be submitted for publication in a peer-reviewed journal. Such a manuscript must include an original analysis of data, either newly collected, existing, or from secondary sources (e.g., a review paper is not acceptable, except for a systematic review using meta-analytic statistical techniques). The manuscript should conform to the guidelines of a peer-reviewed journal. A major peer-reviewed journal must be identified by the scholar and approved by the CRTP; the thesis must conform to that journal's manuscript requirements. While it is not required that the manuscript actually be submitted to a journal before consideration as a Master's Thesis, it is hoped that all such Theses will ultimately be submitted for publication.

 

Procedures

The Thesis process will be overseen by Dr. Frederick Kaskel,Associate Director for Thesis Support & Evaluation, and Dr. Ellie Schoenbaum, Director of the Clinical Research Training Program.

 

The Thesis Proposal

Thesis Proposals are due by December 1 of the first year. Required components are:

  1. Title
  2. Description of the Project*
  3. Mentor's name and signature
  4. Include the specific peer-reviewed journal whose format will be used
  5. A proposed timetable (for data collection and draft submission)
  6. Members of the Thesis Advisory Committee.

*The project description (item #2 above) should indicate what research question will be addressed, and should identify at least one testable hypothesis. A brief (1-2 paragraphs) background should focus on justifying the importance of the research. It should indicate a sampling or subject recruitment strategy; a basic study design; an analytic strategy; and sample size calculation. The project description should be no more than 2-3 pages (double-spaced).

 

The Thesis Advisory Committee

Each scholar must have a Thesis Advisory Committee. This Committee will be convened and chaired by the mentor, who will decide on its composition. As a guideline, we recommend that it include at least 3 members of the faculty, selected for both their complementary expertise (clinical, scientific, and methodological/statistical) and their willingness to serve. We also recommend that they should be drawn from a least 2 different departments.

The Thesis Advisory Committee's function is to help and advise the Scholar, to maximize her/his changes of success when the thesis is reviewed and scored. They can best achieve this by setting and maintaining a timeline with appropriate deadlines, and through timely and critical review of drafts. The members of this Committee do not participate in the grading of the thesis.

The Committee should be engaged in the development of the initial proposal. Members may have suggestions for the Proposal that will help the Scholar to:

  • refine the question or hypothesis
  • develop a study design, sampling, or analytic strategy
  • develop a successful IRB submission
  • strategize which Thesis pathway to pursue
  • create a realistic and effective timetable for completion.

Throughout the development of the Thesis, the Committee members may provide critique and feedback on all aspects of Thesis development: methods, analysis, inference, and writing. It is in the Scholar’s best interest to solicit and incorporate their comments.

Several ‘hints’ are provided to maximize the effectiveness of this process:

  • Remember that your Committee members are busy people, and their activities with respect to your Thesis are voluntary service to you, the CRTP, and the School. When you receive prompt feedback, you should acknowledge it with appreciation. If you do not receive prompt feedback, you may want to give a gentle reminder after a reasonable period of time has elapsed.
  • Meet all your deadlines, and provide your Committee members a reasonable turnaround time to get back to you. Be aware of your members’ other obligations when defining "reasonable" – 2 weeks may be sufficient sometimes, but not if you submit a draft on January 15 to a Committee member who’s submitting an NIH grant on February 1.
  • Be realistic in your expectations. Your mentor or collaborator or division head is likely to be more energetically engaged in your project than the chair of another department who is Juggling many competing demands. Seek and expect input consistent with these realities.
  • To be most effective, direct your Committee members to areas of their specific expertise. It may be hard for them to carefully and completely critique a 25-page document. However, it’s relatively straightforward to respond if that document is accompanied by a cover note that says something like: "I’d especially appreciate any insights you can give me on my statistical analysis section (page 6), and on my interpretation of the results (pages 13-15, and Tables 3-5)."

When your Committee members make comments or suggestions, respond to them. Examples of appropriate responses include:

  • "Thank you for your helpful comments. I am working on your suggestions, and will incorporate them in the next draft."
  • "Thank you for your helpful comments. I was particularly struck by ---, and am planning to address this issue by doing ----."
  • "Thank you for your helpful comments. As I work on addressing your critiques, there is one I don’t fully understand. Could you explain what you meant when you said ---"?
  • "Thank you for your helpful comments. I am working on addressing your insightful suggestions, but there is one suggestion you made that I don’t agree with. While you said -----, I believe that -----. Do you think my position on this is wrong?"

The Major Point: Whatever you want to say, respond somehow.

Remember the key role your mentor plays. S/he can help you navigate choppy waters, and can facilitate communication and interaction with your Committee.

It's a good idea to set up face to face meetings, as a group if feasible, or individually if you can't work that out.

All Scholars are required to obtain statistical consultation during the development of their Thesis Proposals. Formal consultation is provided by Dr. Yungtai Lo. If a Scholar has another statistician involved in the project, that person can serve as the statistical consultant with the approval of the CRTP; the name and biosketch of the proposed consultant must be submitted as part of the Thesis Proposal. All Scholars must meet with Dr. Lo or other approved consultant twice during the development of the Thesis, wit the following scheduled:

Spring, year 1: Each Scholar will meet individually with Dr. Lo to review your hypothesis, methodology, sample size estimate, and statistical analysis plan. This will be useful in the development of the Thesis Proposal.

Fall, Year 2: Each Scholar will have a individual follow-up meeting with Dr. Lo.

 

Thesis Grading Process

Thesis grading is pass/fail; the "MS with Distinction" is awarded through a separate process (see below)

For PATHWAY B, reviewers will be selected by the CRTP. There will be 2 reviewers for each submission, who will receive the manuscript and grading form. The form will allow for pass/fail grading. Written critiques will generally not be provided to the candidate.

M.S. "with distinction"

The candidate will be eligible for an "MS with Distinction" if a "manuscript" submission is actually submitted to a journal prior to graduation, and is accepted for publication within the next 12 months.

For Scholars who are first author on original manuscripts which are based on analyses from multicenter or other studies that require final approval of a Study's Executive Committee as the last step prior to submission to a journal for peer review are eligible for an MS "with distinction" if 1) the manuscript was submitted to the Executive Committee or equivalent prior to CRTP graduation and 2) the paper was accepted for publication within 12 months of CRTP graduation.

If one of these criteria is met, the candidate will be considered for the award of an MS with Distinction. The decision will be made by the CRTP Executive Committee, and will consider the thesis (including the funding source or publishing journal) and the candidate's academic performance throughout the CRTP.

NOTE: This designation of "with distinction" may be made after the Scholar has graduated, provided that the grant or manuscript with submitted prior to graduation.

All Scholars, mentors, Advisory Committee members, and reviewers should become completely familiar with the grading guidelines. 

Satisfactory completion of the thesis will qualify for appropriate academic credit toward the completion of the Master of Science degree. Such credit will be awarded on the basis of time spent with faculty (mentor, statistical consultant, and Advisory Committee) in direct communication about the thesis.

Thesis Presentations:
Each Scholar will be expected to present her/his thesis work during a series of seminars held in April or May of the second year. Scholars will have 30 minutes allotted: a 15 minute presentation, followed by 15 minutes of discussion.

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