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Master's Degree Program in Clinical Research

    Applications are due March 21, 2008 for admission in Summer 2008.

    Note:
  • All courses are held in the TICR Program's new facilities at China Basin Landing with the exception of the morning courses during the Summer Quarter, where they are held on the Parnassus campus.
  • Scholars are strongly encouraged to own a wireless-capable laptop computer for use in computer labs in various courses and to take advantage of the wireless internet network at China Basin.
OVERVIEW

The Master's Degree Program in Clinical Research is a two-year course of study intended for advanced pre-doctoral students, post-doctoral fellows, and faculty members who wish to master clinical research methods and pursue independent research careers. Course work extends beyond that which is required for the ATCR Certificate Program to include instruction in advanced epidemiologic and biostatistical methods and specialized topics such as outcomes research, medical informatics, molecular methods in clinical research, and decision and cost-effectiveness analysis. Requirements include a comprehensive review of the literature in the scholar's field, presentation of original work at a national scientific meeting, and publication of a peer-reviewed manuscript. Scholars will work closely with mentors in their home departments and preceptors chosen from the TICR faculty.

OBJECTIVES
  1. Acquire a mastery of a broad set of clinical research methods.
  2. Plan and implement one or more clinical research projects.
  3. Present research findings at a national meeting.
  4. Write a comprehensive literature review and publish one or more first-authored peer-reviewed original research papers.
  5. Obtain experience in the instruction of clinical research methods.
PREREQUISITES
  • Possession of a MD, PhD, DDS or PharmD degree, or currently enrolled as a medical, dental, or pharmacy student and will have completed at least two years of training in respective professional school prior to enrollment in the Master's program.
  • Ability to devote at least 70% of time to this program and to the conduct of the scholar's own research during August to May in at least two academic years.
  • Established relationship with a research mentor.
  • Affirmation of the Professional Conduct Statement (signed during orientation).
PROGRAM OF STUDY

  1. COURSES

This is a two-year course of study. 36 quarter units are required. Trainees will take the majority of their coursework in the first year allowing for focus on independent research in the second year. Grading policy is determined by the UCSF Graduate Division. In particular, scholars should note that UCSF graduate students must maintain at least a 3.0 (B average). It is the policy of the TICR Program that one "C" grade or less (or one "U" grade) will trigger a discussion between the program director and the student about the expected level of performance in the program; two "C" grades or less (or two "U" grades) will trigger a formal review by the TICR Internal Advisory Committee and may result in the student being dismissed from the program.

Other policies and procedures governing graduate study at UCSF may be found at the Graduate Division website.

Course Registration: All students matriculated in the Master's in Clinical Research Degree program must follow the registration process established by the UCSF Office of Admissions and Registrar. Please refer to the Office of Admissions and Registrar website for further information about the registration process, deadlines for filing study lists, adding/dropping courses, and other matters.

REQUIRED COURSES

YEAR 1

Summer

Scholars who have taken and passed summer courses prior to enrollment in the Master's program will be excused from taking these courses if accepted into the program. However, in accordance with Graduate Division policy, retroactive course credit units cannot be granted, and hence scholars will need to take additional coursework in other quarters to compensate for not receiving credit for these summer courses.

Designing Clinical Research
EPI 202 (S. Hulley, Director; 2 units)

This course provides instruction in developing a clinical research question and creating a concise protocol that includes a literature review, study design, subject sampling and recruitment, instruments and other measurement approaches, sample size, consent form, budget and timetable. Each trainee reviews and supports the work of colleagues. The course closely follows the textbook Designing Clinical Research, by S. Hulley and other TICR faculty, now in its third edition.

Building a Career in Clinical Research
EPI 227 (M. Whooley, Director; 0.5 unit)

Trainees learn about choosing a mentor, time management, generating finished projects, getting grants and getting a job; about how UCSF administration works; and about sources of clinical research funding including industry and foundations in addition to NIH and other government agencies.

Responsible Conduct Of Research
EPI 201 (B. Lo, Director; 0.5 unit)

Trainees learn through case discussions how to identify and resolve common ethical dilemmas that arise in clinical research, how research on human subjects is regulated by the federal government, and what constitutes research misconduct. Trainees resolve the ethical considerations involved in the research protocol they develop in the Designing Clinical Research course. This course meets the NIH requirements for training in research ethics.

Introduction to Statistical Computing in Clinical Research
BIOSTAT 212 (M. Pletcher, Director; 1 unit)

Instruction in use of computer software for managing and analyzing clinical research data; roles of spreadsheet and relational database programs; use of STATA for managing, cleaning, describing, and analyzing data.

Fall

Epidemiologic Methods
EPI 203 (J. Martin, Director; 3 units)

Instruction in clinical research study design; measures of disease occurrence and disease association; the different mechanisms of bias in clinical research (selection, measurement, and confounding); and a conceptual approach to multivariable analysis.

Clinical Epidemiology
EPI 204 (T. Newman, Director; 3 units)

Instruction in the research implications of evidence-based clinical medicine, including the specifications of diagnostic tests, screening tests, and prognostic tests.

Biostatistical Methods for Clinical Research I
BIOSTAT 200 (B. Jersky, Director; 3 units)

Introduction to descriptive statistics, distributions, probabability, exploratory data analysis, and selected variable parametric and non-parametric inference. The STATA software package will be used throughout to implement concepts learned in class and to allow scholars to begin to explore their own data.

Winter

Clinical Trials
EPI 205 (D. Grady, Director; 1.5 units)

Instruction in experimental design options; methods of randomization; blinding, interventions and controls; measuring outcomes and adverse effects; follow-up, compliance and postrandomization problems; ethical issues; and working with pharmaceutical companies.

Database Management Systems for Clinical Research
EPI 218 (M. Kohn, Director; 1 unit)

Instruction in choosing the appropriate data management system; design of research databases; options in data entry; form and report generation; computer security; and budgeting for data management personnel and equipment.

Biostatistical Methods for Clinical Research II
BIOSTAT 208 (D. Glidden, Director; 3 units)

Instruction in multiple predictor analyses as a tool for control of confounding and for constructing predictive models.  Topics will include linear regression and logistic regression. The STATA statistical package will be used throughout.

Spring

Systematic Reviews (Meta-Analysis)
EPI 214 (S. Bent, Director; 1 unit)

Instruction in the methods of systematic and unbiased identification of primary research studies; abstraction of data; determination of summary estimates and evaluation of heterogeneity.

Publishing and Presenting Clinical Research
EPI 212 (W. Browner, Director; 1 unit)

Instruction in preparing abstracts, posters, all aspects of manuscripts, and oral presentations; instruction in oral presentations includes videotaping and critique of trainees’ presentations.

Biostatistical Methods for Clinical Research III
BIOSTAT 209 (D. Glidden, Director; 3 units)

A continuation of the Winter Quarter course in multivariable statistical analysis that includes instruction in survival analysis and analysis of repeated measures and clustered data. The course culminates with student presentations of statistical analyses of their own research projects.

Year-Long

Master's Seminar I EPI 220 (T. Newman, Director; 1 unit each quarter)
The seminar provides a forum for presenting scholar's projects, and for evaluating controversies in clinical research.

YEAR 2

 

Winter

Biostatistical Methods for Clinical Research V
BIOSTAT 226 (J. Hilton, Director; 2 units)

Instruction in advanced topics in biostatistics in two subject areas: 1) issues in the design and analysis of randomized clinical trials; and 2) bioinformatics.

Spring

Biostatistical Methods for Clinical Research IV
BIOSTAT 210 (J. Neuhaus, Director; 2 units)

Instruction in advanced topics in biostatistics including individualized instruction in biostatistical methods pertaining to the scholars' research projects. Topics are in part suggested by the class and include, but are not limited to: analysis of health surveys, nonparametric regression techniques, and survival and repeated measures analyses.

Year-Long

Master's Seminar II
EPI 221 (J. Martin (Fall); J. Witte (Winter); R. Hiatt (Spring), Directors; 1 unit each quarter)

The seminar provides a forum for scholars to present their projects and specialized methodologic topics.


ELECTIVE COURSES

Fall

Measurement in Clinical Research
EPI 225 (A. Stewart, Director; 1.5 units)

Instruction in the critical importance of measurement to clinical research including: defining concepts prior to selecting measures; evaluating the conceptual and psychometric adequacy of measures; and locating, reviewing, selecting potential measures.

 

Winter

Decision & Cost-Effectiveness Analysis
EPI 213 (J. Kahn, Director; 2 units)

Instruction in creating decision trees and other analytic models; obtaining appropriate probabilities, utilities and costs; and completing analyses using customized software.

Medical Informatics
EPI 206 (I. Sim, Director; 1 unit)

Instruction in the core concepts of medical informatics: vocabularies, interchange standards, decision support systems, and how computers are used to manage information in health care and to support clinical research.

Molecular and Genetic Epidemiology I
EPI 217 (J. Witte, Director; 1.5 units)

Introduction to the concepts, principles, and use of molecular and genetic methods in epidemiologic and clinical research and how to develop a framework for interpreting, assessing, and incorporating molecular and genetic measures in research.

Spring

Clinical Research with Diverse Communities
EPI 222 (E. Perez-Stable, Director; 1.5 units)

Instruction in the meaning of race, ethnicity, social class, and culture, and how these constructs affect the conduct and interpretation of clinical research.

Molecular and Genetic Epidemiology II
EPI 219 (S. Sen, Director; 1.5 units)

Instruction in selected statistical aspects of population-based and family-based candidate gene association studies, quantitative trait mapping in model organisms, and methods for dealing with multiple comparisons.

Lab Practicum for Molecular and Genetic Epidemiology
EPI 223 (J. Wiemels, Director; 1 unit)

Introduces practical aspects of the generation of molecular and genetic data from human clinical specimens, including blood and oral cavity specimens.

Outcomes Research
EPI 211 (A. Bindman, Director; 1.5 units)

Instruction in types of questions that can be addressed with large administrative and clinical databases; gaining access to these databases; determining validity of information; risk adjustment; linking datasets; and building registries.

Qualitative Research Methods
EPI 240 (E. Boyd, Director; 1.5 units)

Introduces basic qualitative research methods used in clinical settings: question design and interviewing techniques; focus group analysis; ethnographic fieldwork, notes and narrative analysis; and audio and video data collection and analysis.

Translating Evidence Into Practice
EPI 245 (R. Gonzales, Director; 2 units)

An introduction to the different target audiences and approaches needed to translate biomedical evidence into practice. The course is the gateway for scholars who plan for additional study within this discipline but also suffices as cross-exposure for scholars from other disciplines. In addition to didactic work, scholars are guided through the creation of a research protocol aimed towards translating their particular choice of evidence into practice.

TICR Policy Regarding Academic Credit for Courses Taken in the Past.

Scholars may also choose from a diverse array of other graduate level courses at UCSF.

SAMPLE COURSE SCHEDULE

 

  1. ACCOMPLISHMENT OF THE FOLLOWING PRODUCTS OF CLINICAL RESEARCH
  • Preparation of a comprehensive literature review: For this requirement, the scholar will compose a comprehensive review of the literature pertinent to his or her research question. This review should take the form of a three to five page single-spaced report, similar in format to the "Background and Significance" section of an NIH proposal, that demonstrates the scholar’s mastery of the field’s literature and provides the rationale for his/her proposed project. Emphasis should be placed not only in describing the findings of prior work but also providing a methodologic critique of sentinel studies. If numerous other studies have been performed on the scholar’s research question, the scholar should explain why further work (which may include a formal meta-analysis) is needed. If little or no prior work has been performed, the scholar should focus on background work just proximal to the question posed, again with an emphasis on methodologic critique. It is expected, although not required, that this requirement be completed by the end of the first year in the program.
  • First-authored oral or poster presentation at a national or international meeting: This requirement involves submission of a first-authored abstract to a nationally or internationally recognized scientific meeting/conference within the scholar's academic field and acceptance of that abstract for either poster or oral presentation. The abstract should describe a study of a comparative nature (not simply a case report or case series) using data analyzed (but not necessarily collected) during residence in the Master's program. It may be acceptable in selected cases, with pre-approval by the scholar's Master's Committee, to present work that was started prior to enrollment in the program. It is expected that the work represent a substantive contribution to the scholar's research field.
  • Submission as first author of a peer-reviewed manuscript: Using data analyzed (but not necessarily collected) during residence in the Master's program, the scholar will prepare and submit a first-authored manuscript for publication in a peer-reviewed journal that is approved by the Master's Committee. It may be acceptable in selected cases, upon approval of the scholar's Committee, to submit work that was started prior to enrollment in the program. The manuscript should describe a study of a comparative nature and not simply a case report or case series. The manuscript may be a comprehensive extension of the work submitted in abstract form to a national meeting. It is expected that the work represent a substantive contribution to the scholar's research field. The format should follow that suggested by the journal to which submission is intended. Achievement of this requirement will be considered complete upon satisfactory review by the scholar's Master's Committee and upon written correspondence indicating receipt of the manuscript by an approved peer-reviewed journal. Of note, it is not acceptable for a scholar to present an already submitted, accepted, or published manuscript to his/her committee and expect automatic approval. The final arbiters of the soundness of the work will be the Master’s Committee members and not the journal editors or its reviewers.
  1. INSTRUCTIONAL EXPERIENCE IN CLINICAL RESEARCH

All scholars will be required to serve as instructional assistants (typically in their second year) for one or more courses in the TICR program. This experience will typically involve leading a weekly small-group discussion section of 10 to 15 students, holding office hours for students, and grading homework assignments and projects. Scholars will receive feedback on their performance both from the Course Director and from students, who are polled anonymously using the TICR Program’s web-based course evaluation system.

  1. FILING FOR GRADUATION

The UCSF Graduate Division’s “Completion of Degree Requirements” form should be used to document the completion of the required number of course units and the three required products of clinical research. Scholars should use this form to have their Master's Committee members mark their signatures attesting to the satisfactory completion of each written requirement. Scholars must be registered for the quarter during which they complete the last of their requirements, whether it is coursework or any of the written products. The "Completion of Degree Requirements" form must be completed and submitted to the Program Coordinator by the end of the quarter during which the scholar plans to graduate.

The “Completion of Degree Requirements” form is available in a ready-to-use Microsoft Word format (created on Microsoft Word 2000 for the PC). To use this, click on the "Microsoft Word Format" button below. The word document should then appear in your browser. Next select "File > Save As" from the menu bar and save a local copy of the document to your computer. Make sure to save a copy of the file on your computer before attempting to use the file.

If you are not able to access the application in the Microsoft Word format, please download the .pdf version of the form by clicking on the pdf button above. This can then be printed out and completed by typing where indicated.


MASTER'S COMMITTEE

Each scholar selected for the Program will be asked to form a Master's Committee, which will consist of three faculty members:

  1. A representative from the scholar's academic field (e.g., cardiology). This individual should be conducting primary research in the scholar's chosen field and will typically be a faculty member at UCSF. Upon approval from the TICR Steering Committee, individuals from outside of UCSF (e.g., UC, Berkeley; Stanford; or Biotechnology/Pharmaceutical Industry) may serve in this capacity. To request to include an individual outside of UCSF, scholars should provide the Master's Program Director with the individual's curriculum vitae and a letter of justification.
  2. An epidemiologist/clinical researcher faculty member (primary or secondary/affiliated appointment) from the UCSF Department of Epidemiology and Biostatistics. If possible, a faculty member with working knowledge of the scholar's substantive interests should be chosen.
  3. A biostatistician faculty member (primary or secondary/affiliated appointment) from the UCSF Department of Epidemiology and Biostatistics. If possible, a faculty member with working knowledge of the scholar's substantive interests should be chosen.

The purpose of this committee is both to provide mentorship and to evaluate the achievement of the requirements for graduation. Scholars should select and submit committee members to the Master's Program Director by the end of the Winter Quarter in the first year. One committee member should be selected as the Chairperson, whose role is to arbitrate when there is significant disagreement among committee members or to advocate for the scholar if he/she is experiencing difficulties gaining access to other committee members or scheduling meetings of the committee. The Chairperson must hold either a primary or secondary/affiliated faculty appointment in the Department of Epidemiology and Biostatistics. It is expected that scholars will meet with their committees at least quarterly to review progress and set future objectives.

By the end of their first year, scholars will be required to complete the "Initial Committee Review" form indicating, 1) that they have had at least one meeting with all 3 members of their Master's Committee present and, 2) that the committee members and scholar agree that the scholar is making satisfactory progress toward meeting the program requirements (i.e., the comprehensive literature review, first-authored presentation and manuscript). The completed form should be sent to Chris Ireland at Box 0560 by June 30 of the first year in the program. Scholars must complete this form in order to be eligible to register for subsequent quarters.

At no less than 6 months prior to the date that scholars anticipate completing the last of their original research research products (i.e., the comprehensive literature review, first-authored presentation and manuscript), scholars are required to complete the "Pre-Graduation Review" form indicating that they have had at least one meeting with all 3 members of their Master's Committee present where the content and timeline were agreed upon regarding the completion of the three research products. For example, if the scholar plans to graduate at the end of the Spring quarter of the second year (the minimum length of stay in the program), then he/she will need to file for graduation by approximately June 7 and thus should complete the "Pre-Graduation Review" form by no later than December 7. The purpose of this "Pre-Graduation Review" meeting is to ensure that the Committee is well aware of the exact projects the scholars have chosen to fulfill their requirements. The completed form should be sent to Chris Ireland at Box 0560.

At no less than 3 months prior to the date that scholars anticipate completing the last of their original research products (i.e., the comprehensive literature review, first-authored presentation and manuscript), scholars are also required to complete the "Final Graduation Review" form indicating that they have had at least one meeting with all 3 members of their Master's Committee present where a final plan and timeline were agreed upon regarding the content and completion of the three research products. For example, if the scholar plans to graduate at the end of the Spring quarter of the second year (the minimum length of stay in the program), then he/she will need to file for graduation by approximately June 7 and thus should complete the "Final Graduation Review" form by no later than March 7. The purpose of this "Final Graduation Review" meeting is to ensure that the Committee is well aware of and agrees with the final plans the scholar has made to fulfill the program's research product requirements. The objective is to avoid last minute submissions to Committee members, which defeat the purpose of obtaining the members' well-reasoned advice. It is, however, anticipated that the scholar will continue to meet with Committee members, either together or individually, after this required "Final Graduation Review" meeting for further mentoring and review of the scholar's work. When planning for final approval of products by Master's Committee members, scholars should expect that Committee members may require as long as three weeks to return comments to the scholar. Therefore, Committee members should be presented with drafts of the required products well before the scholars' anticipated graduation. The completed form and electronic files of all three required products should be sent to Chris Ireland at Box 0560.

At all required Committee meetings (and any other meetings held with the full committee), the scholar should take the responsibility for setting the agenda for the meeting, including sending out the agenda and accompanying materials (e.g., drafts of products) by e-mail at least one week prior to the meeting.

UCSF GRADUATION

In late May of each year, the UCSF Graduate Division invites all Master's Program scholars who anticipate graduating in the calendar year to participate in university-wide graduation ceremonies. Information about the ceremony is distributed in approximately March of each year.

GRANTWRITING TUTORIAL

Although not a required component of the program, scholars in the Master's Degree Program in Clinical Research are eligible to receive assistance in grantwriting via a tutorial with Mr. Tom Mitchell. In this tutorial, Mr. Mitchell will work with a select number of scholars individually over the course of several months to guide them through the grant writing process, to instruct them regarding how to write individual grant components (e.g., specific aims, background and significance, methods, etc.), to review and edit successive drafts of individual components, and to ensure timely completion and submission of grant applications. The grantwriting tutorial will be offered 3 times a year, in accordance with NIH funding cycles for career development and investigator-initiated research projects (i.e., February 1, June 1, and October 1, or January 2, May 1, and September 1 for HIV-related projects). The tutorial will be open to post-doctoral fellows and faculty members in the Master's Degree Program who would be classified at NIH as a “new investigator” and who intend to apply for either a patient-oriented research career development award (NIH K series) or submit their first investigator-initiated research grant (NIH R series) for a clinical research project. Scholars intending to apply for substantial grants to other agencies or foundations are also eligible. Scholars interested in this tutorial should contact Mr. Mitchell (tmitchell@psg.ucsf.edu) directly at least 5 months prior to the proposed submission deadline.

APPLICATION

To apply for the Master's program starting in Summer 2008, you must complete the online UCSF Graduate Division application, and pay the $60 nonrefundable processing fee by March 21, 2008. When completing the application below, please choose the program name, "Clinical Research, MAS."

In addition to the Graduate Division application, you must also complete a detailed Master's Degree Program application. The Master's application is available in a ready-to-use Microsoft Word format (created on Word for Office 97 for the PC). To use this, click on the "Microsoft Word Format" button below. The word document should then appear in your browser. Next select "File > Save As" from the menu bar and save a local copy of the document to your computer. Make sure to save a copy of the file on your computer before attempting to use the file.

If you are not able to access the application in the Microsoft Word format, please download the .pdf version of the application by clicking on the pdf button below. This can then be printed out and completed by typing where indicated.

Scholars either currently in or graduated from the ATCR Credit-bearing Certificate Program may submit updated versions of their original applications to the ATCR Program. Such scholars must still provide all necessary transcripts and three new letters of recommendation.

Completed Master's applications in MS Word format should be sent by email to Chris Ireland, MPH, Program Coordinator (cireland@psg.ucsf.edu). A signed hard copy of the application should also be sent to:

Chris Ireland, MPH
University of California, San Francisco
Box 0560
San Francisco, CA 94143

Deadline: Applications are due by March 21, 2008 for admission in Summer 2008.

Costs: The Master's Program is a minimum two-year course of study, requiring registration for seven quarters (Summer, Fall, Winter, Spring in the first year and Fall, Winter, Spring in the second year). Fees for 2008-2009 are $17,500 per year for the two-year program. Selected applicants will be eligible to have their fees offset by a Department of Epidemiology and Biostatistic Scholarship of up to $7600 the first year. Those applicants who meet the following criteria will be eligible:

  1. Demonstrated excellence in the performance of academic work and clinical care, based on prior transcripts, publications, and letters of recommendation. This criterion will be evaluated by the Master's Degree Program Admissions Committee.
  2. Concurrent enrollment in a UCSF-sponsored residency or post-doctoral fellowship program; or student in good standing at the UCSF School of Medicine, Dentistry, or Pharmacy; or individuals who hold full-time salaried UCSF faculty or academic positions.

An additional offset of fees will be available in the scholar's second year in the program depending upon the scope and magnitude of his/her contribution as an instructional assistant.

TICR Policy Regarding Financial Credit for Courses Taken in the Past.

Scholars are also strongly encouraged to own a wireless-capable laptop computer for use in computer labs in various courses and to take advantage of the wireless internet network at the TICR Program's facility at the China Basin Landing Building.

The statistical software package Stata (Stata Corporation, College Station, Texas) is used in the program. The TICR Program has arranged for a sizeable discount for UCSF-affiliated personnel via the Stata GradPlan program.

Interviews: Selected applicants will be interviewed by the admissions committee or its designate.