PhD in Clinical Reasearch
The Ph.D. in Clinical Research is designed for those outstanding candidates who are health professionals that desire a more intense educational experience to prepare them for a career in clinical or translational research. The program provides a strong didactic foundation combined with a mentored clinical research experience leading to a doctoral degree in Clinical Research.
4 tracks/training areas are offered within the Ph.D. in Clinical Research Program:
- Translational Research: Bench to Bedside
- Clinical Trials Research
- Population, Outcomes and Implementation Research
- Molecular Epidemiology
Within the context of these specific tracks, students may choose to develop an area of concentration or focus, developing specific expertise in:
|General Clinical Research||Outcomes Research|
|Health Services Research & Health Policy Research||Ethics|
|Behavioral Research & Cognitive Tools||Genomics & Personalized Medicine|
|Biostatistics: Quantitative and Qualitative Methods||Drug Development|
|Epidemiology: Basic, Molecular and Clinical||Clinical Trials Research|
|Informatics & Bioinformatics||Translational Science|
These areas of special focus build upon strengths reflective of the Icahn School of Medicine at Mount Sinai, Graduate School of Biomedical Sciences, and Mount Sinai’s Institutes and Departments.
The attainment of a PhD in Clinical Research requires
- Successful completion of coursework
- Satisfactory completion of Qualifying Exam as judged by the student’s respective Multidisciplinary Advisory Committee (MAC)
- Approval of proposed thesis by MAC to allow a student to proceed with their dissertation research
- Successful dissertation defense as deemed by the student’s MAC
Multidisciplinary Advisory Committee (MAC)/Doctoral Committee
PhD candidates will form a Multidisciplinary Advisory Committee (MAC), which will also serve as the dissertation committee, no later than December 15th of Year 2 but preferably before that to allow conversation about the student’s research to take place well in advance. The MAC will consist of the following 5 individuals, which does not include mentor(s):
- at least one member of the Clinical Research Education Program core faculty
- a biostatistician. If you choose a member of the core faculty as your biostatistician, you do not need another member of the core faculty in your committee. However, if that is the case, you will still need to fill that slot to make up a committee of 5 members.
- two faculty with expertise in the area of research and or discipline of the trainee
- one faculty member from a complementary discipline.
From the 5 required MAC members above, one member will be selected as the Chair of the Committee by the Program Leadership (see below for additional details)
Not more than two members of the above committee may be from a comparable academic setting, other than Mount Sinai. The majority of the dissertation committee, including the committee chair must be members of the Graduate School Faculty. Additional faculty, such as collaborators of the mentor, may be included as non-voting members on the committee. Non-voting committee members including faculty from Mount Sinai are those who have:
- directly collaborated on the project
- co-authored papers or abstracts with the student on any project and/or working on projects that will lead to future publications
- been substantially involved in supervising the work or advising for the thesis work
Please note that the student’s mentor(s) cannot be present during any portion of the Thesis Proposal Oral Presentation. However, the mentor(s) must be present during the Dissertation Defense but must remain silent throughout the duration of the defense.
The Director, Co-Director or the PhD Track leader for the Clinical Research Education Program, The Director for CePORTED and the Graduate School Dean for Translational Biomedical Sciences must each approve the Committee roster and will select a senior member of the committee, to serve as the Chair of the Committee and will outline the duties of the reviewers and of the Committee. A copy of the Declaration for PhD in Clinical Research Form (see Appendix B) which includes the name of the dissertation mentor(s) and the MAC members must be provided to the Clinical Research Education Program Office by December 15th of year 2 if matriculated in 2011 or later, and by the start of year 3 for students matriculated in 2010. Students matriculated in 2009 should follow the instructions provided to them by the Clinical Research Program Office. The student will be responsible for obtaining signatures from their MAC members and the Program Office will assist the student in obtaining signatures from the program leadership (Director, Co-Director, and Graduate School Dean).
The doctoral committee has the responsibility to advise the student during the progress of the candidate’s research and has the authority to require that the research and dissertation meet a high quality standard, including the authority to require a rewrite of the thesis proposal and/or the written dissertation, in whole or in part. The student must meet with their MAC yearly and complete the Progress report form after each meeting (see Appendix B) along with the MAC. The form must be submitted to the CLR program office every year and before the defense.
The committee conducts the final oral examination and determines whether the dissertation meets the acceptable standards. It will be up to the committee as to when the student is ready to defend their dissertation. The student must submit the progress report form to the CLR program office as proof that the committee has met and decided that the student is ready to defend.
PhD Qualifying Exam and Dissertation
I. Program Milestones
A. Written Comprehensive Qualifying Exam and Thesis Proposal Oral Presentation:
Students should confer with the Program Director or Co-Director as well as with their MAC as to their suitability and readiness for the written comprehensive qualifying exam and the Thesis Proposal Oral Presentation. For KL2 scholars, the written proposal and oral presentation can be done in parallel with the qualifying exam. For all others, 1) the qualifying exam must be done first (by the end of the student’s second year in the program and after they have completed the “Integrative Problem Solving in Clinical and Translational Research” course) 2) followed by the written thesis proposal, and 3) the oral presentation of the proposed thesis.
1. Written Comprehensive Qualifying Examination and Submission of Thesis Prospectus:
(a) Written Comprehensive Qualifying examination – The written comprehensive qualifying examination will include pre-selected questions provided at the time of the examination. This exam will be administered twice a year at pre-selected times (January and June). Students must register for and attend the “Integrative Problem Solving in Clinical and Translational Research” course during their second year, prior to taking the exam. Students must submit a Written Comprehensive Qualifying Exam Registration form to the CLR program office at least 4 weeks prior to the scheduled exam. The CLR PhD committee will be required to sign the form indicating whether the student is ready to take the exam or not. Specific instructions regarding the exam will be emailed to students after the form is submitted and approved by the program. A. The examination will be assessed by the Core Faculty of the Clinical Research Education Program. The exam is worth a total of 100 points and students will have to score a total of 65 points and above in order to pass the qualifying exam. Students will only be permitted to retake the qualifying exam once. This policy is consistent with the Icahn School of Biomedical Sciences policy.
(b) Submission of Thesis Prospectus in the format of an NIH proposal but reduced in size (6 pages in total with no more than 1.5 pages for Specific Aims, Background & Significance/Rationale). Hypothesis to be tested, null hypothesis and question to be asked need to be clearly articulated. Major emphasis should be on Methodology to be employed including Study Design and Statistical Analysis. Reasons for the approaches you chose should be articulated and potential pitfalls and alternative approaches highlighted. Preliminary Data can be included as well. Bibliography, survey &/or other validated or to be developed instruments, questionnaires, tables and figures that may be needed, will not count toward the page limit for the proposal. This document must be submitted to the Committee at least four weeks in advance of the oral presentation. The format of this proposal shall be as follows:
i. Formatting Instructions:
Font: Use Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color and font size of 11 points or larger (A Symbol font may be used to insert Greek letters of special characters; the font size requirement still applies). Type may be no more than 6 lines per inch.
Page Margins: Use at least one half inch margins (top, bottom, left and right) for all pages.
Figures, Graphs, Tables, Charts, Figure Legends, Footnotes: You may use a smaller type size (no smaller than 10 size font) but it must be in a black color, readily legible and follow the font typeface requirement. Color can be used in figures; however, all text must be in black font color, clear and legible.
Questionnaires, surveys, other validated or to be validated instruments: The same font size as outlined for the proposal document should be employed.
2. Thesis Proposal Oral Presentation:
The Thesis Proposal Oral Presentation must be completed no later than six months after the successful completion of the written comprehensive qualifying examination and submission of the thesis prospectus (see 1a and 1b above). For KL2 Scholars, the Thesis Proposal Oral Presentation can be done in parallel with the written qualifying exam and written thesis prospectus. All students should submit a Thesis Proposal Oral Presentation Registration Form at least 4 weeks prior to the Thesis Proposal Oral Presentation, (see appendix B).The following suggestions are made regarding the format of the oral presentation:
The Thesis Proposal Oral Presentation will be conducted by members of the students MAC and will be led by the chair of that committee. The chair of the committee must enforce all rules of the Examination, including those pertaining to
the role of the mentor. In addition, the Director or Co-Director of the Clinical Research Education Program or the PhD track leader must be present during the Thesis Proposal Oral Presentation.
The student’s mentor cannot be present during any portion of the Thesis Proposal Oral Presentation. Before the Thesis Oral Presentation begins, the student will be asked to leave the room for a few minutes so the committee can discuss the student’s performance to date, the structure of the exam, the written thesis proposal and raise any specific points that would be important to discuss during the presentation. Once this review is completed, the student will be called into the room and the presentation will commence. The student should present their work using power point slides. Copies of the slides should be provided to the MAC on the day of the presentation. The student’s portion of the presentation should be approximately 30 minutes long.
The purpose of the Thesis Proposal Oral presentation is to assess the working knowledge of the student’s respective field of inquiry and the ability to demonstrate critical thinking and sufficient acumen regarding clinical research design, and analytical methods as they relate to their chosen field of inquiry. The committee should evaluate the student’s ability to:
- evaluate and synthesize relevant literature
- articulate and elaborate on specific aims
- evaluate any preliminary data of relevance to the project, that might already be available
- discuss experimental designs, qualitative &/or quantitative methods, and alternative strategies and methods for analysis, as it applies to the work planned
Once the committee is finished asking questions, the student will be asked to leave the room. At this point the committee should decide whether the proposal is accepted or not and if accepted, will it be with minor, major or no revisions and whether the Thesis Proposal Oral presentation should be re-presented. The student will only be permitted to re-present the thesis proposal once, within two months of the first attempt.
Within 24 hours of the presentation (or as soon thereafter as possible), the Chair of the student’s MAC overseeing the examination will meet with the student’s mentor to provide a detailed summary of the student’s performance. It is critical for the mentoring process that the mentor is fully informed about this.
No extensions will be granted except under extenuating circumstances. Requests for extensions of established examination deadlines should be made at least 4 months prior to the deadline. Students who fail to meet the examinations deadlines will be placed on academic probation.
3. Outcome of the Thesis Proposal Oral Presentation:
Taking into account both the written thesis proposal and the Thesis Proposal Oral Presentation, all members of the MAC should sign the Thesis Proposal Oral Presentation Voting form (see appendix B) at the end of the presentation and the form must be returned by the Chair of the committee to the CLR program office immediately following the presentation. The following voting options are available to the MAC:
Satisfactory without revisions
Satisfactory with minor revisions (no re-presentation to the committee required)
Satisfactory with major revisions (re-presentation to the committee required)
If the MAC determines that a re-presentation must occur, or that revisions must be made to the Thesis Proposal, the details, including a deadline of when the revisions are due, must be communicated to the student and the CLR program office, in writing, by the Chair of the committee within 2 days of the Presentation. If a re-presentation is required, a Thesis Proposal Oral Re-Presentation Registration form, (see Appendix B) will need to be submitted to the Clinical Research Education Program Office formalizing this request. The student should then work with the Program Administrative Assistant to find a date and time within 90 days of the date the first Thesis Proposal Oral Presentation.
4. Registration for the Written Comprehensive Qualifying Exam and the Thesis Proposal Oral Presentation
Students must fill out the Written Comprehensive Qualifying Exam Registration Form (see appendix B) and submit the form with the appropriate signatures to the program office 4 weeks before the scheduled exam.
To schedule the Thesis Proposal Oral Presentation inclusive of thesis proposal (or re-presentation), the dissertation mentor (s) and the student should check the proposed date with the MAC members and communicate the proposed date with the CLR Program office to find out which member of the CLR Program (the Director or Co-Director of the Clinical Research Education Program or the PhD track leader) will be available to attend the presentation. Once a date has been established the student will need to submit a copy of the Thesis Proposal Oral Presentation Registration form (or Re-Presentation form) (see appendix B) with the appropriate signatures to the Clinical Research Education Program Office at least 4 weeks prior to the presentation. The student is responsible for scheduling the presentation and should communicate with the Program Administrative Assistant to find a room for the presentation if needed. The student is responsible for communicating the final date, time and location to the individuals involved in the presentation and to the program office. The student should also email their written thesis prospectus to their committee members, the member of the CLR program attending the presentation and to the Program Administrator at least 4 weeks prior to the oral presentation to give everyone enough time to review the written thesis. Failure to register and provide the appropriate information to the committee members and program office in a timely manner may result in a cancellation of the presentation. If a student does not register for a presentation that is conducted, the Clinical Research Education Program Office reserves the right to require a re-presentation or to require a notarized statement from the student and the Committee certifying the number of times the student has presented.
B. Admission to Candidacy
Admission to candidacy for the PhD degree in Clinical Research constitutes a promotion of the student to the most advanced stage of graduate study and provides formal approval to the candidate to devote essentially exclusive attention to the research and the writing of the dissertation.
To qualify for admission to candidacy, students must:
- Be a student in good standing
- Have completed required core coursework with a minimum of a B in each core course and have an overall grade point average (GPA) of 3.0
- Have passed the Written Comprehensive Qualifying Exam and the Thesis Proposal Written and Oral Presentation
- Have received approval of the proposed subject and plan of the dissertation from the dissertation committee following a prospectus meeting of the committee, to be held in conjunction with the Thesis Proposal Oral Presentation.
C. Doctoral Dissertation:
For the dissertation, the student along with their mentor must extend an invitation to an outside individual who is an acknowledged expert in the field to serve as an examiner during the dissertation defense. This person will be a voting member. Therefore, the dissertation committee will consist of the 5 MAC members chosen for the Thesis Proposal Oral Presentation, plus the additional outside examiner.
1. First Option: The first option is to submit three first authored manuscripts that have been accepted for publication in peer reviewed journals. The three manuscripts must be thematically related to one another and to the dissertation proposal that was approved by the student’s five member dissertation committee and represent an original new body of work. The manuscripts must be accompanied by an introductory chapter that discusses the implications of the research findings and provides a description of plans for future research.
2. Second Option: The second option is to submit a more traditional dissertation that includes, at a minimum, chapters describing background, methods, analyses/results and conclusions of the dissertation project.
Either option must involve a substantive piece of original and independent research grounded in an appropriate body of literature and theory. High priority – both during the process of selection of the dissertation research topic and in the evaluation of the product of the dissertation research will be placed on the extent to which the project is innovative and advances the field in which the student is working.
The written work must conform to the Mount Sinai Graduate School of Biomedical Sciences format, as outlined in the Graduate School of Biomedical Sciences handbook.
When the student has completed the written dissertation document, it must be read and approved by the Dissertation Committee. The student should submit the Dissertation to each member of the committee as early as possible, but no later than two weeks before the Defense. Committee members may reschedule the Examination if not given the appropriate amount of time to prepare for it. Before the final scheduling of the Defense, the student must meet with their committee to get approval from the committee to defend their thesis. The student must once again complete the Progress report form and obtain signatures from the entire MAC and submit the form to the program office no later than 4 weeks prior to the defense to indicate that this process has taken place and that the student has been given permission to defend their thesis. The student must complete the Dissertation Defense and Seminar Registration form along with the Report of Dissertation Defense form or Approval of Revised Dissertation form (see appendix B) and return this form to the Clinical Research Education Program Office. The student must include with the written document the statement of authorship page.
Students and the Dissertation Mentor (s) should have been made aware that revisions and even additional work/analysis may be requested by the Dissertation Committee. In either event, the Committee should decide and indicate in writing whether the whole committee needs to be reconvened to consider the new draft or whether a subcommittee (or just the Chair of the Committee) may approve the revised draft.
Registration for the Dissertation
To schedule the Dissertation Defense and Seminar, the dissertation advisor/mentor and the student should check the proposed date with the Committee members before submitting the appropriate Registration Form. The student will need to submit a Dissertation Defense and Seminar Registration form (see appendix B), with the appropriate signatures, to the Clinical Research Education Program Office at least 4 weeks prior to the Defense. The student is responsible for scheduling the Defense and should communicate with the Program Administrative Assistant to find a room for the exam. The student is also responsible for communicating the final date and time to the individuals involved. Failure to register in a timely manner may result in a cancellation of the Defense. If a student does not register for a Dissertation Defense that is conducted, the Clinical Research Education Program Office reserves the right to require a re-examination or to require a notarized statement from the student and the Committee certifying the number of times the student has been examined. The student is expected to bring the Report of Dissertation Defense form (see appendix B) on the day of the Dissertation Defense. This Form needs to be signed and returned immediately following the completion of the Dissertation Defense to the Clinical Research Education Program Office. If the Committee determines that there are revisions to be made, the information will be communicated to the student in writing. The student will need to submit an Approval of Revised Dissertation form (see Appendix B)once the revisions have been made.
The Defense and Seminar:
The thesis defense is comprised of two parts, the public seminar and the closed session. Both parts must take place on the same day with the public seminar preceding the closed session. The public seminar will consist of a 45-60 minute power point presentation on the student’s work, open to the Mount Sinai scientific community, and will serve as the presentation to the MAC. Therefore, the committee chair must make sure that all members of the MAC, the outside examiner, the mentor(s) and a member of the CLR leadership be present for the public seminar since the student will not repeat the power point presentation during the closed session. The MAC and mentor(s) will be asked to remain silent during the public seminar and will reserve their questions for the private closed session. It is the student’s and dissertation mentor’s responsibility to appropriately announce the seminar to the public e.g. via email, and to the program at least 4 weeks prior to the Seminar. Once the student notifies the CLR program office of the date and location of the public seminar, the program office will communicate the information to the Graduate School in Biomedical Sciences office which will in turn send a school wide email to announce the seminar.
The closed session of the thesis defense, will take place after the public seminar. Once again, the committee chair must make sure that all members of the MAC, the outside examiner, the mentor(s) and a member of the CLR leadership be present for the defense. Only the MAC and the outside examiner are considered voting members. The Defense should take roughly 2 hours.Student’s mentors must attend the defense but must remain silent throughout the entire process. The purpose for the mentor’s presence is to allow him/her to assess first hand the student’s performance in order to subsequently assist them in addressing the observed deficiencies. If the mentor fails to remain silent, he/she may be asked by the chair of the committee to leave the room. Copies of the power point slides used during the public seminar must be provided to the MAC during the closed session. There is no limit to the number of questions the MAC might ask or how long it might take. Once the committee has finished asking their questions, the student and the mentor will be asked to leave the room so that the committee members can discuss the outcome of the defense. The student is then asked back into the room and the decision and comments are shared with the student.
The student is expected to bring the Report of Dissertation Defense form (see attached) on the day of the Dissertation Defense. This Form needs to be signed and returned immediately following the completion of the Dissertation Defense to the Clinical Research Education Program Office by the student. If the Committee determines that there are revisions to be made, the information will be communicated to the student in writing. The student will need to submit an Approval of Revised Dissertation form (see attached) once the revisions have been made.
Once the student has successfully defended their dissertation, they will have a maximum of three months to deposit their written dissertation in the library. Students who have not deposited their thesis within three months after their successful defense will be administratively withdrawn from the program. In the event that a student decides at a later date to either deposit or obtain a transcript they will need to pay a required fee.
Once a student has successfully defended the dissertation, made all of the revisions and is ready to deposit the Dissertation, she/he should deposit the dissertation electronically according to the instructions in The Graduate School of Biomedical Sciences Depositing your Doctoral Instructions document (see Appendix B). Students should submit the Student Checkout Form, the Clearance from the Real Estate Division for Deposit Form (see Appendix B), and The Graduating Student Exit Survey Form (see Appendix D) to the Clinical Research Education Program Office before depositing their dissertation. Failure to do this can result in a delay of the student’s graduation. Please refer to the section on “Graduation Application Form” and “Other Requirements Preceding Conferral of Degree” on page 41 for more information about Graduation.
The dissertation may be deposited at any time during the year, but the following deposit deadlines and enrollment requirements determine the date of the degree. No degree will be awarded unless the thesis is deposited in the library by one of the required due dates listed below.
|For the Degree to be awarded||You must Deposit by:||And be enrolled during the :|
|September 30||September 15||Preceding Spring Semester|
|January 31||January 15||Preceding Fall Semester|
|May (MSSM Graduation)||April 15||Current Spring Semester|
|June 30||June 1||preceding Spring semester|
The degree is awarded on September 30, January 31, June 30 or the date of the Icahn School of Medicine at Mount Sinai annual Commencement in May. Students depositing by January or April deadline, will receive their diploma at Commencement. Students depositing by the September deadline or the June deadline, may at the discretion of the Dean for Translational Science (or Associate Dean for clinical/Translational Research Education), participate in the prior May Commencement exercise, but will not receive their diploma until after September or June. By March 1, students must notify the Registrar of their intent to deposit their thesis on or before the April, September, or June deposit deadline in order to be included in the Commencement exercises of that year. Commencement information will be sent during the spring semester to the student’s last email address recorded with the Graduate School Office/Clinical Research Education Program. If the student fails to deposit their thesis by the end of their 5th year in the PhD program, their dissertation mentor must petition the Dean in writing for permission to extend the students status. The petition must include a timetable for completing the dissertation and must also be signed by the student.