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Applications for the ATCR Program for 2008-09 are due by June 2, 2008.

Noteworthy:

• All courses are held in the TICR Program's facilities at China Basin Landing with the exception of the morning courses during the Summer Quarter, when 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.
• Application and payment for the ATCR Program includes the courses offered during the summer quarter (i.e. the Summer Clinical Research Workshop). Please do NOT register and pay separately for the Summer Clinical Research Workshop. We will let you know if you are accepted into the ATCR Program in early July. If you are not accepted into the ATCR Program and desire to take the Summer Clinical Research Workshop, you will still have time to register for the summer program.

OVERVIEW

ATCR is a four academic quarter program intended for advanced pre-doctoral students, post-doctoral fellows and faculty members who desire rigorous training in the methods and conduct of clinical research. This includes instruction in the epidemiologic and biostatistical methods used in observational and experimental clinical research as well as training in the oral and written presentation of clinical research. In addition to required coursework, scholars are expected to develop and implement their research projects throughout the year and will have access to TICR faculty for methodologic guidance. Trainees achieving program objectives are granted a Certificate of Program Completion.

OBJECTIVES

1. Learn the methods required to perform both observational and experimental clinical research.
2. Plan and implement one or more clinical research projects.
3. Analyze, interpret, and present clinical research data.

For more information on objectives and requirements for a Certificate of Program Completion, please see Requirements and Goals.

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 the respective professional school prior to enrollment in the ATCR program.
• Supervisor's assurance that at least 70% of time will be available September to June to divide between the activities of this program and the conduct of the trainee's clinical research projects.
• Access to a research mentor in trainee's home department.
• Affirmation of the Professional Conduct Statement (signed during orientation).

TWO TRACKS FOR RECEIVING PROGRAM CREDIT

Traditional ATCR Program

We offer two options for those seeking admission to the ATCR program. The first is the traditional ATCR Program that we have offered in the past culminating in a Certificate of Program Completion from the Department of Epidemiology and Biostatistics for scholars who successfully complete program requirements. This option is ideal for those who desire to gain the core knowledge and skills needed to become a clinical researcher but who do not feel the need to obtain an official transcript from the University of California listing course credits. This would apply to scholars who do not plan to attempt to transfer credit received for completed ATCR courses to graduate degree programs either at UCSF (e.g., the TICR Master's Degree Program in Clinical Research) or at other universities. This is a lower cost option compared to the credit-bearing ATCR program. In order to apply for this program, please follow the instructions below for Application to Traditional ATCR Program.

Credit-bearing ATCR Program

The second option is the credit-bearing ATCR Certificate Program that offers trainees the opportunity to earn graduate division credit for the courses taken as part of ATCR. Students choosing this option would then have an official UCSF transcript indicating the courses and grades earned, and those who successfully complete the program would receive a Certificate of Program Completion from the University of California. This program is primarily for those who are uncertain about pursuing a formal degree (e.g., the TICR Master's Degree Program in Clinical Research at UCSF) at the beginning of the program and who desire more to time make that decision. Students who elect the credit-bearing ATCR Certificate Program will be able to apply units of coursework credit taken in ATCR in the Summer, Fall, and Winter quarters toward the Master's Degree in Clinical Research if they apply and are accepted into the Master's program. Students would need to decide and apply by the published deadline for the Master's program (typically mid-March). Please note that admission into the Master's Program is competitive and that satisfactory completion of courses taken while in the ATCR Certificate Program is not a guarantee of acceptance into the Master's Program. Please also note that if you intend to apply to the Master's program, you will need to take the ATCR courses on a graded basis following the grading policies for the Master's Program. Finally, since the ATCR credit-bearing program is a UCSF Graduate Division Certificate Program, it necessarily comes with higher fees. In order to apply for the credit-bearing ATCR program, please follow the instructions below for Application to Credit-bearing ATCR Certificate Program.

In summary, the prerequisites, program of study, and mentoring requirements described below are identical for the two tracks. The differences between the tracks are the ability to apply credits toward the Master's Degree in Clinical Research, the nature of the Certificate granted, and cost.

PROGRAM OF STUDY

REQUIRED COURSES (Summer | Fall | Winter | Spring | Year-long)

Summer

Designing Clinical Research
EPI 202 (S. Hulley, Director; 2 units)
This course follows the text Designing Clinical Research to provide instruction in developing a research question and creating a 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 produces a 5-page protocol for an actual study and reviews and supports the work of colleagues.

Responsible Conduct Of Research
EPI 201 (B. Lo, Director; 0.5 units)
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. Each trainee produces a written document resolving the ethical considerations involved in the research protocol developed in the Designing Clinical Research course.

Building a Career in Clinical Research
EPI 227 (M. Whooley, Director; 0.5 units)
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 and career options in industry and foundations as well as NIH and other government agencies. Each trainee produces a detailed 2-year career plan.

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

ATCR Seminar
EPI 230 (M. Pletcher, Director)
These monthly seminars provide a support group for discussing the design or conduct of trainees' studies and for critique of contemporary clinical research literature.

Grant Writing Workshop on Mentored Career Development Awards
(T. Mitchell, Director; not for credit)
Instruction in writing successful grant applications for NIH mentored career development awards. Workshop uses examples from patient-oriented research career development awards (K23s). Underlying concepts for the career development plan, mentoring plan, and research plan also apply to research scientist development awards (K01s) and clinical scientist development awards (K08s).

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.

MENTORING

Structured mentoring by faculty members experienced in the scholar's chosen academic discipline is an essential element of becoming an accomplished clinical researcher. While the ATCR curriculum and faculty will provide the methodologic guidance to enable the scholar to plan and implement clinical research, this does not substitute for the benefits derived from a relationship with mentors who work primarily in the scholar's field. Hence, we require that each student receive guidance from:

• A home Department Chair (or Division Chief) or Fellowship Program Director: This is the person in the home Department or Division who assures that the scholar has sufficient time allotted for clinical research and provides resources for the research.
• A research mentor: This is an established scientist who meets regularly with the scholar, reviews progress, provides scholarly guidance, and monitors whether facilities and resources are adequate.

APPLICATION TO TRADITIONAL ATCR PROGRAM

The ATCR 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.

Completed ATCR applications in MS Word format should be sent by email to Allison Deneen, Program Assistant (adeneen@psg.ucsf.edu). A signed hard copy of the application should also be sent to:

Allison Deneen
Program Assistant, Advanced Training in Clinical Research Certificate Program
University of California, San Francisco
UCSF Box 0560
185 Berry St, Suite 5700
San Francisco, CA 94107
415-514-8135 (telephone)

Deadline: Applications for the ATCR Certificate Program for 2008-2009 are due June 2, 2008. Notice of admission decisions will be made by early July.

Cost: The current fee for 2008-2009 is $8180 for University of California Fellows and Faculty. This includes fees for all four quarters (Summer, Fall, Winter, and Spring). Fees do not include books, supplies, or software. Fees in subsequent years are subject to change.

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.

APPLICATION TO CREDIT-BEARING ATCR PROGRAM

To apply to the credit-bearing ATCR Certificate program you must complete the online UCSF Graduate Division application below, including payment of a $60 non-refundable processing fee by June 2, 2008. When completing the application, please choose the program name, "Clinical Research, ATCR."

In addition to the Graduate Division application, you must also complete the ATCR application. The ATCR 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.

Completed ATCR applications in MS Word format should be sent by email to Allison Deneen, Program Assistant (adeneen@psg.ucsf.edu). A signed hard copy of the application should also be sent to:

Allison Deneen
Program Assistant, Advanced Training in Clinical Research Certificate Program
University of California, San Francisco
UCSF Box 0560
185 Berry St, Suite 5700
San Francisco, CA 94107
415-514-8135 (telephone)

Deadline: Applications for the credit-bearing ATCR Certificate Program for 2008-2009 are due June 2, 2008. Notice of admission decisions will be made by early July.

Cost: The fee for the credit-bearing ATCR Certificate Program in 2008-09 is $11,747. This includes the $8,180 ATCR program fee for University of California fellows or faculty plus the UCSF student services fees of $3,567. The latter fees are required for all persons in credit-bearing certificate or degree programs. This includes fees for all four quarters (Summer, Fall, Winter, and Spring).

Fees do not include books, supplies, or software. Fees in subsequent years are subject to change.

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.