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

• Faculty Advisors

• Near-Peer Mentoring Program

• Thesis Research Mentors (MSCR)

• Dissertation Research Mentors (PhDCR)

• Multidisciplinary Advisory Committee (MAC) (PhDCR only)

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.

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.

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)

• Provide assistance with challenges that arise with regard to courses and/or research

• Provide advice on funding and career opportunities

CRTP, MSCR and PhDCR students are required to meet with their assigned faculty advisor no later than the end of Spring I each year. Students are asked to notify the Program Manager of their scheduled appointment with their faculty advisor. The Program Manager will then forward the appropriate material for the advisor to review with the student. Notes of the meeting will be put into the student’s file for review by the Program Directors. In addition, the student is also required to meet with the program administration before the start of the Spring II term each year.

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

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 Declaration for PhD in Clinical Research 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 Dissertation Defense and Seminar Registration form.

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 Section 4: Curriculum 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

• Behavioral research and cognitive tools

• Genomics and personalized medicine

• Biostatistics: Quantitative and qualitative methods

• Drug development

• Epidemiology: Basic, molecular and clinical

• Clinical trials research

• Informatics and bioinformatics

• Translational science

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 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 program milestones:

Required coursework includes the core curriculum required of all first-year doctoral students (see Section Four) as well as second-year track-specific coursework as listed in the program’s course checklists. 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 Section Seven.

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

• Derive translational questions from clinical research data

• Prepare the background and significance sections of a research proposal

• Critique clinical and translational research questions using date-based literature searches

• Extract information from the scientific literature that yields scientific insight for research innovation

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

• Use evidence as the basis of the critique and interpretation of results of published studies

• Identify potential sources of bias and variations in published studies

• Interpret published literature in a causal framework

• Identify gaps in knowledge within a research problem

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

• Design a research study protocol

• Identify a target population for a clinical or translational research project

• Identify measures to be applied to a clinical or translational research project

• Design a research data analysis plan

• Determine resources needed to implement a clinical or translational research plan

• Prepare and application to the IRB

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

• Integrate elements of translational research into given study designs that could provide the basis for future research, such as the collection of biomedical specimens, nested studies, and the development of community-based interventions

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

• Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts

• Implement quality assurance systems with control procedures for data intake, management, and monitoring for different study designs

• Assess data sources and data quality to answer specific clinical or translational research questions

• Implement quality assurance and control procedures for different study designs and analysis

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

• Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question

• Compute sample size, power, and precision for comparisons of two independent samples with respect to continuous and binary outcomes

• Describe the uses of meta-analytic methods

• Defend the significance of data and safety monitoring plans

• Collaborate with biostatisticians in the design, conduct, and analyses of clinical and translational research

• Evaluate computer output containing the results of statistical procedures and graphics

• Explain the uses, importance, and limitations of early stopping rules in clinical trials

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

• Illustrate the nature of the contributions in consulting and/or collaborating with biomedical and health informaticians throughout the life cycle of individual clinical and translational research projects: use the terminology and principles of biomedical informatics to interact effectively with informaticians; discriminate among the different subdomains of biomedical informatics in order to identify the appropriate informatics consultant or collaborator; and enumerate the roles of biomedical informatics specialists in the design, development, and implementation of translational research projects

• Describe the essential information generation, management, analysis, transformation, summarization, and visualization methods that apply to CTS data, such as: genomic, proteomic and other “-omics” data; clinical data; imaging data; consumer and patient-reported data; and population-level and environmental exposure data

• Identify, retrieve, and manage biomedical and health science knowledge through literature searches using advanced search techniques (MeSH, PubMed, Google Scholar, etc.)

• Explain the role of health information technology standards in the interoperability of research, clinical, and administrative information systems and on secondary use of data for clinical and translational science

• Compare and contrast the organizational roles and principal responsibilities essential for access management, and governance of data related to clinical and translational science

• Describe the essential functions of major research computer systems (e.g., clinical trials management systems, biospecimen management systems, research grant and finance management systems, and research services tracking systems) that are relevant to clinical and translational scientists

• Describe the essential functions of the major clinical systems (e.g., EHR and its feeder systems, such as radiology and lab) that are relevant to clinical and translational scientists and the challenges to using these data for research

• Utilize informatics-based tools in translational research including: locate relevant informatics tools; select appropriate informatics tools; and use those tools in research for managing and analyzing biomedical and health information

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

  • Explain the special issues that arise in research with vulnerable participants and the need for additional safeguards

  • Determine the need for a risk-benefit ration that is in balance with the outcomes in clinical and translational research

  • Describe the elements of voluntary informed consent, including increasing knowledge about research, avoiding undue influence or coercion, and assuring the decision-making capacity of participants

  • Assure the need for privacy protection throughout all phases of a study

  • Assure the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research

  • Adhere to IRB application procedures

  • Explain how the structural arrangement of science and the research industry may influence the behavior of scientists and the production of scientific knowledge

• Responsible Conduct of Research Competencies

  • Apply the main rules, guidelines, codes, and professional standards for the conduct of clinical and translational research

  • Adhere to the procedures to report unprofessional behavior by colleagues who engage in misconduct in research

  • Implement procedures for the identification, prevention, and management of financial, intellectual, and employment conflicts of interest

  • Apply the rules and professional standards that govern the data collection, sharing, and protection throughout all phases of clinical and translational research

  • Apply elements of voluntary informed consent, of fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants

  • Explain the need for privacy protection and best practices for protecting privacy throughout all phases of a study

  • Explain the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research

  • Explain the function of the IRB

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

• Translate clinical and translational research findings into national health strategies or guidelines for use by the general public

• Explain the utility and mechanism of commercialization for clinical and translational research findings, the patent process, and technology transfer

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

• Describe cultural and social variation in standards of research integrity

• Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g. gender, age, ethnicity, race)

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

• Clarify language differences across disciplines

• Demonstrate group decision-making techniques; manage conflict

• Manage a clinical and/or translational research study

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

• Validate others as a mentor

• Foster innovation and creativity

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

• Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds

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

• Analyze the ethical complexities of conducting community-engaged research

• Specify how cultural and linguistic competence and health literacy have an impact on the conduct of community-engaged research

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

• Curricular Requirements

• Graduation Requirements

• Standards for Maintaining Satisfactory Progress

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.

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 MD-MSCR Program (PORTAL). Students can find the following information in this section.

• Program Information

• Program Competencies

• Program Requirements

  • Curricular Requirements

  • Requirements to Graduate

  • Standards for Maintaining Satisfactory Progress

• Curriculum

  • CRTP and MSCR Curriculum

  • PhDCR Curriculum

  • Requirements for Coursework on Responsible Conduct in Research

  • Independent Study

  • Electives Offered in Other Programs or at Other Institutions.

• Advising

  • Faculty Advisors

  • Near-Peer Mentoring Program

  • Thesis Research Mentors

  • Dissertation Research Mentors

  • Multidisciplinary Advisory Committee

• Master's Thesis

  • Registration, Mentor Selection, and Thesis Proposal

  • Master's Thesis First and Final Drafts

  • Timelines for the Master's Thesis and Forms

  • Student Checkout Requirements

• Doctoral Dissertation

  • Written Dissertation Research Proposal

  • Oral Presentation of Dissertation Research Proposal

  • Admission to Candidacy

  • Written Dissertation, Defense, and Deposit

  • PhDCR Timeline and Required Forms

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:

The attainment of a CRTP certificate requires the following:

• Successful completion of coursework; see the 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

• Minimum cumulative GPA of 3.0

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)

• Successful dissertation defense as deemed by the student’s MAC and subsequent deposit

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 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 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:

Year One

• BIO6400 Biostatistics for Biomedical Research (Fall)

• CLR0006 Spectrum of Methods in Clinical Research I (Fall)

• CLR0501 Computational Tools for Clinical Research (Fall)

• MPH0812 Applied Linear Models I (Spring I)

• CLR0016 Spectrum of Methods in Clinical Research II (Spring I)

• CLR0700 Professionalism & Ethical Issues in Clinical Research (Spring I)

• MPH0822 Applied Linear Models II (Spring II)

• CLR0007 Spectrum of Methods in Clinical Research III (Spring II)

• CLR0011 Grant Writing (Spring II)

Year 2

• Coursework as defined by the student’s selected track

• CLR0017, CLR0018 & CLR0019 Clinical and Translational Research Journal Club and Seminar Series I-III

• CLR0012, CLR0014 and & CLR0015: Integrative Problem Solving in Clinical and Translational Research I-III

Written Comprehensive Qualifying Exam

Following the exam, students will be informed in writing of their result, and will also have the opportunity to review their exams in person. Furthermore, all students will have the opportunity to review their answers with each respective faculty member, if helpful or desired on the part of the student. Students will not be permitted to keep a copy of their exam. A copy of their exam will remain as part of their file, which they may access at any time.

Doctoral Thesis

It 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

  • Graduating Student Exit Survey by May 15 (will be emailed to students after submitting the online Student Checkout form)

• 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

• Meeting with the research mentor at regular intervals between June 1 of year one and year two

• Successfully completing and passing each of the MSCR milestones by deadline indicated on the MSCR checklist, including:

  • Research Agreement

  • Thesis Proposal

  • Thesis First Draft

  • Thesis Final Draft

  • Final Thesis deposit

• Submitting all for graduation by deadline indicated on the MSCR checklist, including:

  • Graduation Application form (online form will be emailed to students in February of year two)

  • form by May 15 of year 2

  • by May 15 of Year 2

  • Graduating Student Exit Survey by May 15 of year two (will be emailed to students after submitting the online Student Checkout form)

  • Final Thesis deposit to by June 1 of year two

• Completing all above requirements within two years of matriculation; in exceptional circumstances, students may be given permission by the Program Director to complete the MSCR in as little as one, and not more than three years.

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

• Taking and passing the Written Comprehensive Qualifying Exam in June of year two

• Submitting the Written Dissertation Research Proposal by February 28 of year three

• Conducting and passing the Dissertation Research Proposal Oral Presentation by March 31 of year three

• Completing and successfully defending the dissertation when deemed ready by MAC

• Depositing properly formatted version of the final approved thesis, containing signatures of the Mentor and Program Director

• Completing all requirements listed above by June 1 of the fifth year in the program; in exceptional circumstances, students may be given permission by the Program Director to complete the PhDCR in up to seven years

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 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.

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

• CRTP and MSCR Curriculum

• PhDCR Curriculum

• RCR

• Independent Study

• Electives Offered in Other Programs or at Other Institutions

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:

• Meet with the Program Director and the faculty sponsoring your independent study to discuss your plans at least six weeks prior to the start of the independent study

• Complete the Independent Study Proposal form, which is available on Blackboard, and submit it to the Program Manager with the appropriate signatures at least 3 weeks before the start of the independent study

• Before beginning your independent study, register for independent study credits through the registration system

• Once approved, complete the project/course of study

• Complete the Independent Study Postscript Report and submit to the Program Manager with appropriate signatures no later than 3 weeks after your project has been completed

• Request that your faculty sponsor complete the Independent Study Faculty Sponsor form and submit it to the Program Manager no later than three weeks after you complete the study

• Review the Postscript Report and Evaluation with your faculty sponsor

• Complete the Independent Study Student Evaluation of Faculty form no later than three weeks after the study has been completed.

Note that all required independent study forms are available in the “Forms” folder on the CLR Blackboard site.

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:

• Registration, Mentor Selection, and Thesis Proposal

• Master's Thesis First and Final Drafts

• Timelines for the Master's Thesis and Forms

• Student Checkout Requirements

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

• CLR0700 – Professionalism and Ethical Issues in Clinical Research

These courses also include curricular material relevant to rigor and reproducibility. Please note that if you are NIH funded, or plan to be, you are required to complete the GSBS RCR training, an 8 hour course directed by Matthew O’Connell, PhD, Senior Associate Dean for PhD Programs. This course is offered twice a year. For specific dates of this course offering please contact the Clinical Research Education Program Manager.

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 Emerging Investigators 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 Research Agreement 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 Master’s Thesis Proposal and Form 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

• Specific aims

• Patient population

• Study design and analytical methods

• Responsibilities of student and skills that will be acquired by student for the project (include what the student will do and how the mentor will help)

• Timeline for research

• Whether project requires IRB approval or is exempt

• Potential statistical tests

• Possible figures and tables

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 Research Agreement form no later than September 30. Their full proposal will be required by November 15 of that same year.

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 Elective Approval 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 Evaluation Form for Transfer of Credit 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 CLR Blackboard site.

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 Master’s Thesis First Draft Approval 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:

• Statement of purpose

• Background

• Hypothesis

• Specific aims

• Research design

• Methods

• Results

• Conclusion

Annual Best MSCR Thesis Prize

Each year, prior to graduation, the best MSCR thesis (or theses) will be selected by the program leadership and awarded a prize for the best thesis, to be presented at the annual graduation achievement awards ceremony. The awardees are selected based upon the first draft of their thesis.

Master’s Thesis Final Draft

When submitting your final draft, be sure to address all questions, concerns, and requested revisions provided to you by the program in your first draft. Your final draft should be read and approved by your mentor and then uploaded as a Word document using the online Master’s Thesis Final Draft Approval form. Your mentor will be able to access the form and approve or not approve the final draft. If approved, the final 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 final draft along with written feedback and/or requests for revisions. Students who are approved with major or minor revisions must make the requested revisions and submit a new Master’s Thesis Final Draft Approval form along with the revised final draft. Once the final draft has been “approved without revisions,” students may begin the process of depositing the thesis to ProQuest.

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:

• Font: Use Arial, Helvetica, Palatino Linotype or Georgia typeface in black with a font size of 11 points or larger. Symbol font may be used to insert Greek letters of special characters, however, the font size requirement still applies. Type should 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, Legends, Footnotes: You may use a smaller type size (no smaller than size 10 font). Color may 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.

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 Depositing your Master’s Thesis Guide. Upload this final document to both ProQuest and Blackboard.

• Student check-out form: Complete the online Student Checkout 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.

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.

CRTP students who apply and are accepted to the MSCR program and who plan to graduate on June 30 should follow the below timeline:

Students who have been granted permission to delay their graduation to September 30 should follow the below timeline. Those who do not follow the timeline below will not be making satisfactory progress in the program, which can result in academic probation and eventually dismissal from the program.

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

• Earned a cumulative GPA of 3.0

• Have passed the Written Comprehensive Qualifying Exam

• Have received approval of the proposed subject and plan of the dissertation from the respective MAC following a successful Dissertation Research Thesis Proposal Oral Presentation

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 Dissertation Research Proposal Oral Presentation Registration 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 Dissertation Research Proposal Oral Presentation Registration form with the appropriate signatures to the Program Manager at least four weeks prior to the presentation. The student is responsible for scheduling the presentation and should communicate with the Program Coordinator 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 PhD Oversight Committee attending the presentation, and to the Program Manager at least four weeks prior to the oral presentation to give committee members sufficient 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 reserves the right to require a re-presentation or to require a notarized statement from the student and the MAC certifying the number of times the student has presented.

Rules and Procedures for the Oral Presentation

The Dissertation Research Proposal Oral Presentation will be conducted by members of the student’s 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, a member of the PhD Oversight Committee must be present during the Thesis Proposal Oral Presentation.

The student's mentor should be present during the Dissertation Research Thesis Proposal Oral Presentation. However, the mentor must remain silent throughout the entire process including the questioning phase of the presentation. The purpose of 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, they may be asked by the chair of the committee to leave the room. Before the Oral Presentation begins, the student and mentor 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 and mentor will be called into the room and the presentation will commence. The student should present using PowerPoint 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 thirty minutes long.

The purpose of the 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 which may be available

• Discuss experimental designs, qualitative and/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 and mentor will be asked to leave the room. At this point the MAC will take into account both the written proposal and the Oral Presentation and vote on whether the proposal is accepted, and if accepted, whether with minor, major or no revisions. Following this discussion, the student and mentor will be asked to re-enter the room and the chair of the committee will discuss the committee's decision. All members of the MAC should sign the Dissertation Research Proposal Oral Presentation Voting form at the end of the presentation. The form must be returned by the Chair of the committee to the CLR Program Manager immediately following the presentation. In addition, if the committee determines that further work is necessary, the Chair will provide this information in writing to the student, mentor and the CLR program within 7 days of the presentation.

No extensions will be granted for the oral presentation 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.

Outcome of the Dissertation Research Proposal Oral 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)

• Unsatisfactory

The student whose oral presentation is deemed unsatisfactory or satisfactory with major revisions will be given one additional opportunity to address the particular area(s) of weakness. Students will need to submit a Dissertation Research Proposal Oral Re-Presentation Registration form to the Clinical Research Education Program Office formalizing this request. The conditions and timing for a re-presentation must be established at the time of the initial presentation.

The re-presentation must occur within 6 months of the initial presentation if the initial outcome was "Unsatisfactory" or within 4 months if the outcome was "Satisfactory with Major Revisions." The information concerning a re-presentation should be communicated to the student and the CLR program by the MAC, in writing, within two days of the initial presentation. A student (with support of the mentor) may request to change the membership of an individual(s) in the re-examination MAC from that of the MAC Examination Committee. However, the student can request a change only if 1) there are major changes to the proposal and the existing committee members do not appropriately represent the expertise necessary, given the changes to the project or 2) if there is a major conflict identified by the student and mentor. The student must receive approval from the CLR program leadership, prior to registration for the re-examination in order to proceed with a change in committee member. In rare instances, the MAC may refuse the student the opportunity to redress the proposal where students have failed to show sufficient research progress and ability.

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.

Written Document Format Options

• Option One: 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 MAC and represent an original new body of work. In addition, each manuscript must be individually approved by the MAC in order to ensure that the above conditions are met. 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.

• Option Two: 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 Depositing Your Dissertation Guide.

When the student has completed the written thesis, it must be read and approved by the MAC. The student should submit the thesis to each member of the committee as early as possible, but no later than four 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 to defend. The student must once again complete the Progress Report form, obtain signatures from the entire MAC, and submit the form to the Program Manager no later than four weeks prior to the defense to indicate that the student has been given permission to defend their thesis.

Students and the dissertation research mentor(s) should be aware that revisions and even additional work/analysis may be requested by the MAC. In either event, the MAC 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 Thesis Defense

To schedule the thesis defense and seminar, the thesis mentor and the student should check the proposed date with MAC members before submitting the appropriate registration form. The student will need to submit Dissertation Defense and Seminar Registration and Progress Report forms with the appropriate signatures, to the Program Manager at least four weeks prior to the defense. The student is responsible for scheduling the defense and should communicate with the Program Coordinator 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 reserves the right to require a re-examination or to require a notarized statement from the student and the MAC certifying the number of times the student has been examined.

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 PowerPoint presentation on the student’s work, open to the Mount Sinai scientific community, and will serve as the presentation to the MAC. The committee chair must make sure that all members of the MAC, the outside examiner, the mentor(s) and a member of the PhD Oversight Committee be present for the public seminar, since the student will not repeat the 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 responsibility of the student and mentor to appropriately announce the seminar to the public via email, and to the program at least four weeks prior to the Seminar. Once the student notifies the Program Manager 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 PhD Oversight Committee be present for the defense. Only the MAC and the outside examiner are considered voting members. The defense should take roughly two hours. Student’s mentors must attend the defense but must remain silent throughout the entire process. The purpose of the mentor’s presence is 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, they may be asked by the chair of the committee to leave the room. Copies of the presentation 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 the duration of the closed session. Once the committee has completed 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 on the day of the defense. This form must be signed and returned immediately following the completion of the defense to the Program Manager. 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 once the revisions have been made.

Dissertation Deposit

By February 1, students must notify the Registrar of their intent to deposit their thesis 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.

Once the student has successfully defended their dissertation, they will have a maximum of three months to deposit their written dissertation to 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.

After successfully defending the dissertation and making all revisions, the student should deposit the dissertation electronically according to the instructions in the Depositing Your Dissertation Guide.

Students should submit the online Student checkout form and the Graduating Student Exit Survey (which will be emailed) before depositing the dissertation. Failure to do this can result in a delay of the student’s 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 by one of the required due dates listed below. The degree is awarded on September 30, January 31, or the date of the ISMMS annual Commencement in May. Students depositing by the January or April deadline will receive their diploma at Commencement. Those students who have a dissertation defense scheduled between April 15 and June 15 may be eligible to participate in the spring Commencement ceremony even though they have not met the April 15 dissertation deposit deadline. In cases where a student is allowed to participate, the diploma will not be awarded at graduation. Only students in good academic standing will be offered this courtesy. Good academic standing should be understood to mean that all coursework has been completed with passing grades and the student’s mentor/committee fully expect the student will successfully defend the dissertation prior to June 15. If either of these criteria is not met, the student will not be allowed to participate in the spring graduation ceremony.

It is important to note that physical diplomas are produced only once per year by ISMMS. Students who do not meet deadlines for a May graduation will not receive a diploma until the following May after they have completed all degree requirements. The PhD in Clinical Research itself can be conferred on two other occasions, September 30 and January 30, following completion of all degree requirements. If necessary, prior to receipt of the actual diploma, students can request a letter from ISMMS Registrar’s office verifying that they have completed the degree requirements and confirming that the degree has been conferred.

If the student fails to deposit their thesis by the end of their seventh year in the PhD program, their dissertation mentor must petition the Dean in writing for permission to extend the student’s status. The petition must include a timetable for completing the dissertation and must also be signed by the student.

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

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.