Master's Degree Program in Clinical Research Director: Jeffrey N. Martin, MD, MPH
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
Acquire a mastery of a broad set of clinical research methods.
Plan and implement one or more clinical research projects.
Present research findings at a national meeting.
Write a comprehensive literature review and publish one or more first-authored
peer-reviewed original research papers.
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.
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.
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.
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.
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:
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.
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.
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:
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.
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.
