Clinical Research Training Program (CRTP) The Clinical Research Training Program (CRTP) is a one-year, 26-credit certificate version of the Master of Science in Clinical Research. Students in this program are not required to take second-year research seminars nor do they write a thesis. Students must make satisfactory progress in the program in order to remain matriculated in the certificate program.

Master of Science in Clinical Research (MSCR) The Masters of Science in Clinical Research (MSCR) is a 38-credit program designed to be completed in two years. In certain cases, coursework can be taken over the course of three years with approval from the program. The MSCR has two main components: 1) graduate courses including biostatistics, bioethics, data analysis, epidemiology, genomics, grant writing, health equity, informatics, methodologic journal club, and research study design; and 2) a mentored clinical research project leading to a Master’s thesis. Students must make satisfactory progress in the program in order to remain matriculated in the degree. They are also required to meet key program milestones, register for all required courses, and complete all general program requirements to ensure timely completion of the degree.

See the table below for key MSCR program milestones:

There are different program requirements for CRTP, MSCR, and PhD students. They include:

• Curricular Requirements

• Graduation Requirements

Program Website: https://icahn.mssm.edu/education/masters/clinical-research/education Program Email: clred@mssm.edu

Program Description

The Clinical Research Education (CLR) Program of The Mount Sinai Graduate School of Biomedical Sciences is designed to foster the development of future leaders in patient-oriented research. These training opportunities are intended to encourage the development of critical thinking necessary to conduct innovative, hypothesis-driven, independent and collaborative clinical/translational scientific research, in an effort to improve patient care and the wellbeing of society. In particular, we hope to enhance the research opportunities of clinical scientists as well as enhance the ability of basic scientists to better position themselves to translate the promise of their respective discoveries into the clinical arena, in a meaningful way with significant impact.

A rigorous curricular foundation designed to promote an in depth understanding of research methodologies and processes essential to translating the promise of scientific discovery into solving problems of disease is central to these educational initiatives, and forms the basis of our Certificate Program, Master of Science in Clinical Research, and PhD in Clinical Research.

The Clinical Research Training Program (CRTP) is an introductory, one-year, part-time certificate version of the MSCR program which includes the core coursework without a Master’s Thesis requirement or 2nd year research seminars and journal club.

The Masters of Science in Clinical Research (MSCR) is a program that provides an exceptional educational experience to outstanding candidates interested or already working in the health care professions. The MSCR program instills the knowledge, skills, and experience to successfully launch clinical and/or translational research-intensive careers. The MSCR has two main components: 1) graduate courses including biostatistics, bioethics, data analysis, epidemiology, genomics, grant writing, health equity, informatics, methodologic journal club, and research study design; and 2) a mentored clinical research project leading to a Master’s thesis. The program is designed to be completed in two years.

The PhD in Clinical Research (PhDCR) is designed for outstanding candidates interested in or actively pursuing a health profession who desire a more intense educational experience to prepare 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. Candidates for the PhD program must already possess an advanced degree (masters or equivalent) to be considered for the program.

Three tracks or training areas are offered within the PhD in Clinical Research Program:

• Translational Research: Bench to Bedside

• Clinical Trials Research

• Population, Outcomes and Implementation Research

These areas of special focus build upon strengths reflective of the ISMMS, Graduate School of Biomedical Sciences, and Mount Sinai’s Institutes and Departments.

At the end of each term, in collaboration with the Registrar, the program leadership will identify those students in our programs who have either failed to maintain a GPA of 3.0 (all students) and/or in the case of the PhDCR students, have not received a grade of B or better, in their required core coursework. Such students will be notified and a meeting will be arranged with the program leadership. In addition to such semesterly meetings, the program is willing to meet with a student anytime during the year to address immediate and time sensitive concerns.

When a Master’s student’s GPA falls below 3.0, the student will meet with the Program Director or another member of the program leadership, develop an individual plan of remediation, and sign a statement of understanding regarding their academic probation status. If the student’s GPA has not reached 3.0 within two terms of having been placed on probation, the student will be asked to withdraw from the program.

Students are expected to complete the MSCR degree in two years. If the required MSCR coursework and master’s thesis is not finished within the required timeframe, the student will be withdrawn from the program unless they have prior approval from program leadership for an extension to complete the program. In rare instances, a student may have approval to complete the program in less than two years. Students should refer to Section Six for more information about graduation.

When a doctoral student’s GPA falls below 3.0, the student will meet with the Program Director and another member of the PhD Oversight Committee, develop an individual plan of remediation, and sign a statement of understanding regarding their academic probation status. If the student’s GPA has not reached 3.0 within two terms of having been placed on probation, the student will be asked to withdraw from the program.

A doctoral student who earns less than a B in a required core course, must re-take the course and earn a B or better. If the student does not retake the course or retakes the course and earns less than a B, the CLR Program may withdraw the student from the PhDCR program.

Students who do not achieve a cumulative GPA of 3.0 within one semester of being placed on academic probation are in danger of having financial aid suspended. In such cases, they should meet with program leadership to take appropriate action.

CRTP

The CRTP curriculum requires students to take a total of 26 credits throughout the Fall, Spring I and Spring II terms. Students should refer to the Clinical Research Education Program’s Blackboard page to review the CRTP course checklist for the year in which they matriculated. All courses must be completed in the sequence in which they appear on the checklist.

MSCR

The MSCR program requires a total of 38 credits (32-33 credits of coursework, and 5-6 Master’s Thesis Credits), to be taken over the course of two years. MSCR students are expected to complete 24-27 credits of coursework in the first year. In the second year, students take the remainder of their required coursework and complete the Master’s Thesis (CLR0001), for which they earn 5-6 credits.

MSCR students may choose one of three designated courses (CRL0610, CLR0301 or CLR0008) to fulfill the elective degree requirement. Any exceptions must be reviewed by the program directors. Students should refer to the to review the MSCR course checklist for the year in which they matriculated. All courses must be completed in the sequence in which they appear on the checklist.

The CLR Program supports the advancement of integrated and interdisciplinary education, training, and career development in Clinical and Translational Science. The National Centers for Translational Science (NCATS), in collaboration with the CTSA Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research. The work group’s final recommendations for core competencies include fourteen thematic areas that should shape the training experiences of junior investigators by defining the skills, attributes, and knowledge that can be shared across multidisciplinary teams of clinician-scientists. The Clinical Research Education Program has recently adopted these program competencies for all students.

The CLR Program uses these thematic competencies to guide overall program learning objectives, overall curriculum development, and course-specific learning objectives. Students will be expected to achieve proficiency in these thematic areas in the course of class work, seminars, journal club, independent study and through the Master’s Thesis and/or PhD dissertation. Attainment of these respective competencies will be assessed through the satisfactory completion of course work.

Core competencies in clinical, translational and patient-oriented research core thematic areas are outlined as follows:

CLINICAL AND TRANSLATIONAL RESEARCH QUESTIONS

• Identify basic and preclinical studies that are potential testable clinical research hypotheses

• Identify research observations that could be the basis of large clinical trials

• Define the data that formulate research hypotheses

LITERATURE CRITIQUE

• Conduct a comprehensive and systematic search of the literature using informatics techniques

• Summarize evidence from the literature on a clinical problem

• Describe the mechanism of a clinical problem reviewed in a manuscript

STUDY DESIGN

• Formulate a well-defined clinical or translational research question to be studied in human or animal models

• Propose study designs for addressing a clinical or translational research question

• Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question

RESEARCH IMPLEMENTATION

• Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs

• Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding

• Incorporate regulatory precepts into the design of any clinical or translational study

SOURCES OF ERROR

• Describe the concepts and implications of reliability and validity of study measurements

• Evaluate the reliability and validity of measures

• Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups

STATISTICAL APPROACHES

• Describe the role that biostatistics serves in biomedical and public health research

• Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis testing, type I and type II errors, and confidence limits

• Scrutinize the assumptions behind different statistical methods and their corresponding limitations

INFORMATICS

• Describe and make use of best practices for developing research instruments and protocols and for communicating results of research that are appropriate to specific audiences and special populations, addressing literacy and numeracy, cultural attitudes, and special terminologies

• Identify how structure and organization of information in a domain can impact researchers’ translational research foci through fundamental data categories and elements, terminologies and taxonomies, and ontologies

• Discuss the fundamental principles and practices that address the ethical, legal, social, privacy, and security implications of biomedical and health informatics

RESPONSIBLE CONDUCT OF RESEARCH

• Clinical Research Ethics Competencies

  • Summarize the history of research abuses and the rational for creating codes, regulations, and systems for protecting participants in clinical research that requires community input

  • Critique a clinical or translational research proposal for risks to human subjects

SCIENTIFIC COMMUNICATION

• Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public and the media

• Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups

• Write summaries of scientific information for use in the development of clinical health care policy

CULTURAL DIVERSITY

• Differentiate between cultural competency and cultural sensitivity principles

• Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study

• Describe the relevance of cultural and population diversity in clinical research design

TRANSLATIONAL TEAMWORK

• Build an interdisciplinary/intradisciplinary/multidisciplinary team that matches the objectives of the research problem

• Manage an interdisciplinary team of scientists

• Advocate for multiple points of view

LEADERSHIP

• Work as a leader of a multidisciplinary research team

• Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem-solving requirements

• Maintain skills as mentor and mentee

CROSS DISCIPLINARY TRAINING

• Apply principles of adult learning and competency-based instruction to educational activities

• Provide clinical and translational science instruction to beginning scientists

• Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clinical and translational research

COMMUNITY ENGAGEMENT

• Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geography

• Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities

• Summarize the principles and practices of the spectrum of community-engaged research

The PhD in Clinical Research (PhDCR) is a 66-credit program designed to be completed on average in five years, and not more than seven years. The program provides a strong didactic foundation during the first two years followed by a mentored clinical research experience leading to a doctoral degree in Clinical Research.

Three tracks/training areas are offered within the PhD in Clinical Research:

• Translational Research: Bench to Bedside

• Clinical Trials Research

• Population, Outcomes and Implementation Research

Each track has clearly defined and required coursework as detailed in of this chapter. Within the context of these specific tracks, students may choose to develop an area of concentration or focus, developing specific expertise in:

• Outcomes research

• Health services research and health policy research

• Ethics

These areas of special focus build upon strengths reflective of the ISMMS, Graduate School of Biomedical Sciences, and Mount Sinai’s institutes and departments.

Doctoral students must make in the program in order to remain matriculated in the degree. They are also required to meet key program milestones, register for all required courses, and complete all general program requirements to ensure timely completion of the degree. See the table below for key program milestones:

Required coursework includes the core curriculum required of all first-year doctoral students (see ) as well as second-year track-specific coursework as listed in the program’s . All second-year doctoral students must take a full year of Integrative Problem Solving in Clinical and Translational Research in order to prepare for the written comprehensive qualifying exam. Additional program requirements are listed in .

There are different curricular requirements and opportunities for CRTP, MSCR, and PhD students. They include:

• CRTP and MSCR Curriculum

• PhDCR Curriculum

The requirement by the NIH for investigators to have "face-to-face" training in Responsible Conduct of Research (RCR) can currently be met by completing the following core courses. These courses are part of the MSCR and PhD curriculum and utilize case-based discussions which is strongly encouraged by the NIH. The courses should be taken in the appropriate sequence as outlined in the degree program checklists:

• CLR0016 – Spectrum of Methods in Clinical Research II

• CLR0017, CLR0018, and CLR0019 – Clinical and Translational Research Journal Club and Seminar series

https://www.etdadmin.com/main/home?siteId=224It is crucial that students familiarize themselves with the standards for maintaining satisfactory progress. Students are expected to attend the new student orientation, review the GSBS Student Handbook and read through the requirements on their coursework checklist in order to be aware of the program’s standards. It is critical that students monitor their own progression through the program, and address any questions or potential roadblocks with the program leadership and/or administration. Failure to achieve and maintain satisfactory progress can result in academic probation, loss of financial aid, and potentially dismissal from the program.

CRTP students maintain satisfactory progress in the program by:

• Maintaining a minimum cumulative GPA of 3.0 throughout the program

• Successful and timely completion of all coursework and milestones as outlined in the

• Submitting all student checkout requirements for graduation, including:

  • Graduation Application form (link to online form will be emailed to students in February)

  • form by May 15
• Completing all requirements for the CRTP within one year of matriculation

MSCR students maintain satisfactory progress by:

• Maintaining a minimum cumulative GPA of 3.0 throughout the program

• Successful and timely completion of all coursework as outlined in the

• Actively searching for and identifying a research mentor throughout the first year of the program

PhD in Clinical Research students maintain satisfactory progress by:

• Earning a minimum of a B in each of the required courses, as stipulated by a student’s selected track

• Maintaining a minimum cumulative GPA of 3.0 throughout the program

• Successfully completing all required coursework within the first two years of the PhD program as outlined in each

The Multidisciplinary Action Committee (MAC) has the responsibility to advise doctoral students as they progress in their dissertation research. The MAC has the authority to require that the dissertation research meet a high-quality standard, including the authority to require a rewrite of the dissertation research 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 along with the MAC. The form must be submitted to the Program Manager annually beginning in year three and before the defense.

The MAC 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.

Identification of MAC Members

By no later than March 31 of year two, a PhDCR candidate will form a Multidisciplinary Advisory Committee (MAC) which will oversee the progress of the dissertation research. With the help of the PhD Oversight Committee and dissertation research mentor(s), the student will identify five MAC members, including a Chair. Required members of the committee include:

• A Biostatistician with appropriate analytical expertise of relevance to the dissertation research proposal

• Faculty with different methodologic and/or phenotypic patient-oriented research expertise of relevance to the proposed dissertation research

• A Chair, selected by the candidate and their respective mentor(s) with expertise of relevance to the proposed dissertation research

No member of the PhD Oversight Committee will be allowed to serve as a voting member on any candidate’s MAC. One member of the PhD Oversight Committee will attend all MAC meetings to assure that all meetings are conducted according to the program policies and procedures.

Not more than two members of the above committee may be from a comparable academic setting other than Mount Sinai. The majority of the committee, including the chair, must be members of the Graduate School Faculty.

MAC Members may not be:

• Collaborators on the project or recent related projects

• Co-authors on papers or abstracts with the student on any project and/or working on projects that will lead to future publications

• Substantially involved in supervising the work or advising for the thesis work

The PhD Oversight Committee must approve the committee roster and the chair, and will outline the duties of the reviewers and of the Committee. A copy of the form, which includes the name of the dissertation mentor(s) and the MAC members must be provided to the Clinical Research Education Program Office by March 31 of year two. The student will be responsible for obtaining signatures from their MAC members and the Program Manager will assist the student in obtaining approval from the PhD Oversight Committee.

Outside Reviewer for Dissertation Defense

In anticipation of the dissertation defense, the student will need to have identified an outside reviewer (preferably not from the institution) with knowledge related to the student's field of study. If the student wishes to identify the outside review at the time that they submit their declaration form, they may do so by including the name of the individual in "Adviser 6" box. Otherwise, the name should be included in the form.

Master’s Thesis First Draft

A first draft of your master’s thesis should be read and approved by your mentor, and subsequently uploaded using the online form. Your mentor will be able to access the form and approve or not approve your first draft. If approved, the first draft will be forwarded to a CLR Program Director, who will provide a grade of “approved without revisions,” “approved with minor revisions,” or “approved with major revisions.” The Program Director will upload a copy of your first draft along with written feedback and requests for revisions, which the student should integrate into their final draft.

Your first draft should not be an outline of your project; it should be a full first draft. Failure to submit a complete first draft will result in a potential delay of your graduation. The first draft should be submitted as a Word document to allow for tracked changes and feedback provided by the program leadership, and should include all of the sections required in a manuscript including:

Although not a program requirement, some students may wish to conduct an independent study to explore a certain research interest or subfield. A maximum of three credits may be awarded per Independent Study. Each independent study credit requires fifteen hours of face time with the Independent Study mentor and thirty hours of non-face time. Please note that while the total hours committed to the pursuit of the Independent Study may be sufficient for more than three credits or more than one elective, students will not receive any more than three credits for one project or course of study. Each student may complete no more than two independent study projects.

An independent study must be a unique experience. Material covered during an independent study project should be highly targeted and not simply a review of the regularly offered coursework. Independent study projects should not be attempts to take CLR courses that are offered routinely during the academic year at times that are more convenient for the student. Students should not expect independent study projects to exempt them from core course requirements without approval by the Program Leadership (MSCR) or PhD Oversight Committee member (PhDCR) in conjunction with the Program Director.

Steps towards formalizing an independent study are as follows:

Students are permitted to take any course listed in the CLR curriculum guide as an elective. Only courses listed in the curriculum guide are approved for CLR credit. Students must request approval from the Program Director prior to registering for a course outside of the CLR curriculum but within the Graduate School at ISMMS.

If a student wishes to take an elective course offered at a different institution, the student must submit a course description and a syllabus from the institution offering the elective course, together with a completed form to the Program Manager. Approval must be given by the Program Director prior to enrolling in the course. Please note that CLR students approved to take courses at CUNY or Cooper Union are responsible for paying the tuition and fees associated with those classes.

Upon completion of the elective course, the student should complete the and submit it to the Program Manager along with an official transcript from the institution where the course was taken. The form and transcript must be submitted in order for the elective to appear on a student’s CLR transcript. Note that all required elective approval forms are available in the “Forms” folder on the .

Experience researching and writing a thesis provides the MSCR student with an opportunity to explore and further develop ideas from lessons learned during coursework, apply them to a specific research endeavor, and demonstrate the student’s mastery of clinical/translational research within a particular area of interest.

The process of completing a Master's Thesis includes the following steps:

The PhDCR program requires a total of 66 credits (37-41 credits of coursework, and 25-30 credits of Doctoral Thesis), to be taken over the course of five years. All students take the same courses in year one, and declare a specialization, or track, at the end of the first year. The second year is spent completing track-specific coursework, as well as a full year of Integrative Problem Solving in Clinical and Translational Research, a full-year course that is designed to prepare doctoral students for the comprehensive qualifying exam at the end of year two. Students should refer to the to review the PhDCR course checklists for their selected track.

Coursework

PhDCR required coursework is as follows:

Entering Clinical Research students are assigned a faculty advisor from the CLR Faculty. The goal of the faculty advisor is to help students navigate the research landscape at ISMMS and the GSBS, the larger scientific research enterprise and monitor the individual student’s academic progress. Students will be assigned a faculty advisor at the start of their first year based upon their initial specified area of research interest, articulated in the application to the program. The role of the faculty advisor will be distinct from that of research mentor. Specifically, the faculty advisor will:

• Provide advice on elective coursework relevant to the area of research focus

• Assist in finding potential thesis/research mentors related to possible research topics and projects of interest (MSCR/PhD)

The role of the thesis research mentor(s) is to guide the student’s research progress, provide professional and personal development and uphold high academic and research standards. Students in the MSCR program must identify a thesis research mentor by June 1 of their first year. The student selects a thesis research mentor with the help of the program leadership and their faculty advisor. Once selected, the thesis research mentor(s) and student should discuss the expectations and goals of the project and commit to working together until the completion of the project. This process is formalized by signing and submitting the online Research Agreement form. The program leadership will sign these respective forms to indicate that the mentoring arrangement meets with the approval of the Clinical Research Education Program.

Registration for Master’s Thesis Credits (CLR0001)

All students are required to register for at least five master’s thesis credits (course number CLR0001). Students who take CLR0008 Introduction to Health Survey Research Methods for two credits as their chosen elective, must register for at least six credits of CLR0001. Students must register for the master’s thesis credits prior to graduation. They may register for these credits during the Fall, Spring I or Spring II terms of year two. In special cases, student may receive permission from the program to register for these credits in Spring II of year one. In select instances, and in particular for those conducting patient-oriented laboratory research, students will be permitted by the program leadership to apply additional credits towards their master’s thesis in lieu of additional courses.

Mentor Selection and Master’s Thesis Proposal Process

First-year MSCR students should meet early on with their faculty advisors and program administration to identify an appropriate mentor for their thesis project. They may also wish to consult the website, which provides advice and resources for students embarking on mentored research projects. The student, together with their thesis mentor(s), should complete the online form indicating willingness to serve as a thesis research mentor, and specifying the research question and data source. The Research Agreement form must be submitted online by June 1 of the first year in the MSCR program. MSCR program leadership will review the Research Agreement form and either approve or not approve the mentor and choice of project. If not approved, program leadership and the faculty advisor will work with the student to make revisions. The student must then resubmit this form for final approval by the CLR leadership.

Master’s Thesis Proposal and Form

The are due on September 10 of year two, and should be completed and uploaded online. The proposal should be no longer than three pages, must be approved by the thesis research mentor before submitting to the program, and contain the following sections:

• Study title

• Rationale for the study/gap in knowledge being addressed

• Hypothesis

Once the proposal and form are submitted to the CLR Program, the Director and Associate Director will review and decide if the proposed project is approved or needs to be further refined or revised. If revisions are required, the student must resubmit the proposal for final approval. Students must receive approval from the program before moving forward with their proposed research.

Please note that a student may submit for their Master’s Thesis a first-author manuscript either submitted for publication, accepted for publication or published during their training which is reflective of their Master’s Thesis work. In this instance, a statement of purpose, introduction, and discussion regarding the findings and impact of the work will need to be added.

Students previously in the CRTP Program who transfer into the MSCR Students who are accepted into the MSCR program, having successfully completed the CRTP, will be entering the second year of the MSCR program, since they will have completed in their CRTP program all of the first year MSCR coursework requirements, with the exception of CLR0011 Grant Writing, the three-term Journal Club sequence, and an elective course.

Students who transfer into the MSCR will be required to declare their mentor and research project by submitting the form no later than September 30. Their full proposal will be required by November 15 of that same year.

In order to graduate, the following materials must submitted in addition to the thesis:

• Master’s thesis evaluation report: The thesis research mentor must complete and sign this form, and the student should then upload to Blackboard.

• PDF of approval pages: Create a title page, copyright page and approval page, according to the templates provided in the Depositing your Master’s Thesis Guide. Obtain your thesis research mentor’s signature on the approval page. Upload all three pages (including the signed approval page) as a single document to Blackboard. The Program Manager will obtain the Program Director’s signature for your approval form, and email to you the signed pages.

• Final formatted version of thesis: Add the title, copyright and signed approval pages to your thesis, which should be formatted according to the . Upload this final document to both ProQuest and Blackboard.

• Student check-out form: Complete the online form. Once submitted, the bursar, library, registrar and CLR program will provide electronic signatures clearing you for graduation.

• Graduating student exit survey: Upon completion of the Student Checkout form, you will receive a graduating student exit survey via email, which you are required to complete.

Section of an Outside Examiner

The student and 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. Altogether, the dissertation committee will therefore consist of the five MAC members chosen for the Dissertation Research Proposal Oral Presentation, plus the additional outside examiner. See Section Five for more information on selecting an outside examiner.

Students who plan to graduate on June 30 of year two should follow the below timeline. Those who do not follow the timeline will not be making satisfactory progress in the program, which can result in academic probation and eventually dismissal from the program.

The goal of the Near-Peer Mentoring Program is to increase access to resources for a successful graduate school experience and to build an active and supportive community by providing students with support from other graduate students, alumni or faculty who are active in the Clinical Research field. The near-peer mentor will serve as a sounding board, share experiences as a member of the CLR Program, help the mentee overcome current challenges, and provide advice when appropriate. Each student in the program will be assigned a near-peer mentor based on their research interest and will meet in an informal setting (over coffee etc.) on a per-term basis or more frequently if needed.

The attainment of a CRTP certificate requires the following:

• Successful completion of coursework; see the CRTP Checklist for a list of required courses

• 26 completed credits

• Minimum cumulative GPA of 3.0

The attainment of a MSCR in Clinical Research requires the following:

• Successful completion of coursework; see the for a list of required courses

• Satisfactory completion and deposit of thesis

• 38 completed credits

Earning a PhDCR requires:

• Successful completion of coursework per the requirements of the , as indicated by achieving a B or better in all required coursework and maintaining a cumulative GPA of 3.0 or more throughout their time in the program.

• Satisfactory completion of the Written Comprehensive Qualifying Exam as defined by achieving a score of 65 or more out of 100.

• Satisfactory completion of the Dissertation Research Proposal Oral Presentation and approval of proposed dissertation research by the Multidisciplinary Advisory Committee (MAC)

Students in the PhDCR program are expected to select a dissertation research mentor(s), with the help of their Faculty Advisor and members of the PhD Oversight Committee by the middle of year two. An effective mentor-mentee relationship is crucial as doctoral students begin their scientific careers. The dissertation research mentor(s) is expected to guide the student’s research progress, provide professional and personal development opportunities and uphold high academic and research standards. Dissertation research mentors must commit to the following when agreeing to mentor a student in the PhDCR program:

• Meet with the student on a regular basis

• Review the student’s progress at regular intervals and provide timely feedback and goal setting advice

• Work with the student to help plan and guide the research project, set reasonable and attainable goals, and establish a timeline for completion of the dissertation research

• Help the student select a Multidisciplinary Advisory Committee and ensure that the student meets with the MAC annually

• Assure that the candidate completes an annual progress report, approved by their respective Mentor(s) and MAC, to be submit to the PhDCR program

• Encourage the doctoral student to attend and present their research at scientific/professional meetings

• Create an environment in which the student can discuss and explore career opportunities and paths that match their skills, values, and interests; and

• Support the student’s career path choices

Admission to candidacy for the PhD 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 in good standing

• Have completed all required coursework with a minimum of a B or better in all required coursework as per their declared track

The written dissertation research proposal must be submitted to the Multidisciplinary Advisory Committee at least four weeks in advance of the oral presentation. Once the document is submitted to the MAC, students must meet with their committee members individually or as a group to receive preliminary feedback, address necessary changes, and get final approval to move forward with the Dissertation Proposal Oral Presentation. The format of the document should follow an NIH proposal but reduced in size. The proposal should be six pages in total with no more than 1.5 pages dedicated to Specific Aims, Background, and Significance/Rationale. The research question, hypothesis and null hypothesis should be clearly articulated. Students should place emphasis on the methodology to be employed, including study design and statistical analysis. Justifications for the approaches chosen should be articulated, and potential pitfalls and alternative approaches highlighted. Preliminary data may be included. Bibliography, surveys and/or other validated or to-be-developed instruments, questionnaires, tables and figures that may be needed, will not be counted toward the page limit.

The format of this proposal shall be as follows:

The oral presentation of the dissertation research proposal must be completed no later than nine months after the successful completion of the written comprehensive qualifying examination. All students should submit a form at least four weeks prior to the Dissertation Proposal Oral Presentation, and no later than February 28 of year three.

Registration for the Dissertation Research Proposal Oral Presentation

To schedule the oral presentation of the dissertation research proposal (or re-presentation), the dissertation mentor 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 PhD Oversight Committee will be available to attend the presentation. Once a date has been established the student will need to submit a copy of the

The Clinical Research Education Program includes the PhD in Clinical Research (PhDCR), MS in Clinical Research (MSCR), Clinical Research Training Program (CRTP), and the dual Program (PORTAL). Students can find the following information in this section.

There are several formal advising processes for CRTP, MSCR, and PhDCR students. They include:

Registration for Doctoral Dissertation Credits (CLR0020)

After passing the Written Comprehensive Qualifying Exam, students must register for 25-30 credits of CLR0020 Doctoral Thesis, depending on the requirements of their track. Once a student has completed all required doctoral thesis credits, they should register for CLR8000 Thesis Continuation, for which no tuition is charged, but which ensures that students remain active.

PhDCR students should consult the table below to determine the appropriate dates and deadlines for milestones and the associated required paperwork.