Class Registration for the 2008
Introduction to Clinical Investigation at UMB
Date: July 28 to August 1, 2008
Time: 9:00 AM to 4:00 PM
Location: Room 106, School of Nursing
Cost: None
Note: The 2008 course is full and registration is closed.
Please contact Cindy Garnett at cgarnett@medicine.umaryland.edu to be placed on the waiting list.
COURSE
TITLE: Introduction
to Clinical and Translational Research at UMB
(PREV TBA)
CREDITS: 2
credits
LOCATION: School of Nursing Room 106
COURSE MASTERS:
Mary-Claire Roghmann, M.D., M.S. (Regular Graduate
Faculty)
John Sorkin, M.D., Ph.D.
FACULTY:
See following page for list of speakers. One or both of
the coursemasters will also be present during the entire course.
PRE-REQUISITES: None
COURSE DESCRIPTION:
This is a one-week, one-credit course providing an
overview of the basic skills, attitudes and resources needed for designing and
implementing a clinical or translational research project. The emphasis will be
on how to obtain these skills and resources on the UMB campus.
COURSE OBJECTIVES:
Students will be able to:
1.
List the
features of a good research question
2.
Compare and
contrast the different study designs in clinical and translational research
3.
Identify the
correct biostatistical method to compare different types of data
4.
List the
advantages of developing a data management system for a research study
5.
Identify key
issues in the responsible conduct of research (conflict of interest, data
fraud, authorship)
6.
Identify the
ethical principles underlying an IRB application
7.
Compare and
contrast the purpose and format of a meeting abstract, peer reviewed
manuscript, and a grant proposal,
8.
Know which campus
organizations to contact for help with federally funded and industry sponsored
research
RECOMMENDED TEXTBOOK:
Designing Clinical Research, 3rd Edition,
by Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady
and Thomas B. Newman
COURSE REQUIREMENTS:
1.
Class
participation: Students are required
to attend each session and participate in the case-based discussions.
2.
Final Exam: Critique a clinical or translational research study
for required elements
EVALUATION AND GRADING:
Participation (10%) and Exam (90%)
SPEAKERS
|
Baumgarten, Mona
Ph.D. Associate Professor Department
of Epidemiology and Preventive Medicine, School of Medicine mbaumgar@epi.umaryland.edu 410-706-1531 |
Kotloff, Karen, M.D. Professor Department
of Medicine and Pediatrics, School of Medicine kkotloff@medicine.umaryland.edu 410-706-5328 |
|
Berlanstein, Debra MLS Liason & Outreach Services Librarian Health Sciences and Human Services Library dberlans@hshsl.umaryland.edu 410-706-8862 |
Perencevich, Eli M.D.,
M.S. Associate Professor Department of Epidemiology and Preventive Medicine, School of Medicine 410-706-0063 |
|
Bozylinski, Khristy MS, CCRC Program Manager Human Research Protections Office
(HRPO) kbozylinski@som.umaryland.edu
410-706-4514 |
Roghmann,
Mary-Claire M.D., M.S. Associate Professor Department of Epidemiology and Preventive Medicine, School of Medicine Director, K30 Program mroghman@epi.umaryland.edu 410-706-0062 |
|
Collins, Joseph Sc.D. Professor Department
of Epidemiology and Preventive Medicine, School of Medicine joseph.collins2@va.gov
410-642-2411 x5288 |
Simoni-Wastila, Linda Ph.D. Associate Professor 410-706-4352 |
|
Dongmo, Samuel
Ph.D. Director, Bioinformatics Core General Clinical sdongmo@medicine.umaryland.edu 410-328-8008
|
Smith, Barbara Ph.D. Professor and Associate Dean for Research 410-706-7363 |
|
Dowling, Thomas C. Ph.D., PharmD Department of Pharmacy Practice and Science tdowling@rx.umaryland.edu
410-706-0884 |
Sorkin, John M.D.,
Ph.D. Associate
Professor Department
of Medicine, jsorkin@grecc.umaryland.edu 410-605-7119 |
|
Hirshon, Jon Mark M.D., M.P.H. Associate Professor Department of Emergency Medicine, Vice-Chair University of jhirs001@umaryland.edu 410-328-7474 |
Stine, O. Colin
Ph.D. Associate Professor Department
of Epidemiology and Preventive Medicine, School of Medicine Ostin001@umaryland.edu
410-706-1607 |
|
Holtz, Patrice RN, MBA Executive Director, Center for
Clinical Trials 410-706-2328 |
Tacket, Carol M.D. Professor Department
of Medicine, Program
Director, General Clinical ctacket@medicine.umaryland.edu 410-328-7369 |
|
Katzel, Leslie M.D., Ph.D. Associate
Professor Department
of Medicine, 410-605-7248 |
Tracy, Kate, Ph.D. Assistant
Professor Department
of Epidemiology and Preventive Medicine, School of Medicine 410-706-1504 |
|
Contact Time in minutes |
Topic/Speaker |
|
|
Monday July 28 |
||
|
30 |
Course Expectations and Introductions Mary-Claire Roghmann, M.D., M.S. John Sorkin M.D., Ph.D |
|
|
90 |
Conceiving the Research Question, Writing Hypotheses and Specific Aims Mary-Claire Roghmann, M.D., M.S. |
Chapter 2 |
|
90 |
Introduction to Clinical Epidemiology Mona Baumgarten, Ph.D |
Chapters 7-9 |
|
90 |
Overview of Study Design Mona Baumgarten, Ph.D. |
Chapters 7-9 |
|
60 |
Choosing Study Subjects: Specification, Sampling and Recruitment Barbara Smith, Ph.D. |
Chapter 3 |
|
Tuesday, July 29 |
||
|
90 |
Principles of Research Ethics Leslie Katzel, M.D., Ph.D |
|
|
90 |
Research Ethics Cases Leslie Katzel, M.D., Ph.D |
|
|
90 |
Institutional Review Board and HIPAA Jon Mark Hirshon, M.D., M.P.H. and
|
|
|
30 |
VA Requirements for Protocol Submission Mary-Claire Roghmann, M.D., M.S. |
|
|
60 |
Clinical Trials Joseph Collins, Sc.D |
Chapter 10-11 |
|
Wednesday July 30 |
||
|
180 |
Introduction to Biostatistical Methods John Sorkin M.D., Ph.D. |
Chapters 5-6 |
|
90 |
Data Management and Analysis Kate Tracy, PhD |
Chapter 16 |
|
30 |
GCRC Carol Tacket, M.D., Bill Hoffman, M.D., Samuel Dongmo, Ph.D., Colin Stine, Ph.D., and Larry Magder, Ph.D. |
|
|
30 |
The Center for Clinical Trials Patrice Holtz, RN, MBA
|
|
|
30 |
Health Sciences and Human Services Library Debra Berlanstein, MLS |
|
|
30 |
Pharmacokinetics & Biopharmaceutics Thomas Dowling, Ph.D. |
|
|
Thursday, July 31 |
||
|
120 |
Health Outcomes Research Measuring Outcomes Using Surveys Eli Perencevich, M.D., M.S. |
Chapter 15 |
|
60 |
Secondary Data Sources Linda Simoni-Wastila, Ph.D. |
Chapter 13 |
|
90 |
Scientific Communication I Mary-Claire Roghmann, M.D., M.S. |
|
|
90 |
Scientific Communication II Mary-Claire Roghmann, M.D., M.S. |
|
|
60 |
Building an Academic Career in Clinical Research Karen Kotloff, M.D. |
|
|
Friday August 1 |
||
|
90 |
Sources of Grant Opportunities Grantsmanship and Grant Structure Budget and Administrative Issues Mary-Claire Roghmann, M.D., M.S |
Chapter 19 |
|
90 |
Overview of Career Development Grants Mary-Claire Roghmann, M.D., M.S. |
|
|
120 |
Putting It All Together Mary-Claire Roghmann, M.D., M.S. and John Sorkin M.D., Ph.D. |
|
|
|
|
|