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The Science of Clinical Investigation

Sponsored by

Johns Hopkins University School of Medicine and
Bloomberg School of Public Health's
Graduate Training Program in Clinical Investigation

***On-Line Registration is not available for this course.***
Please follow the link below to download the course
application and registration form.

Target Audience

The Science of Clinical Investigation curriculum is intended for scientists, clinicians and support personnel fully engaged in clinical investigation.


All courses will be held during the evening at the Johns Hopkins Medical Institutions in Baltimore, Maryland. Lectures, case studies, and small group discussions with faculty will clarify the subject matter. Peer critiques of student projects will be used throughout the sequence. At the end of each course, students will be given a post-test in the form of an exam and/or final project. A certificate of achievement will be presented to those students who have earned a minimum of 70 CME credits and who have satisfactorily completed four or more courses.

Course Description:

The Science of Clinical Investigation

There is a current need for the enhancement of the theoretical and practical skills of clinical scientists in the design, implementation, analysis and interpretation of data from clinical investigations. The following five courses are designed to meet those needs:

Database Design and Implementation in Clinical Research
(Mondays,Wednesdays and Thursdays, 8/14/06 - 8/31/06, 5-7 pm)

Students will acquire basic concepts of relational database design for clinical and basic research. Topics covered will include development of data collection forms, design of a relational database, data quality control, and importing and exporting collected data across different platforms.
Upon completion of this course, participants will be able to:
o Construct a database environment for efficient storage and access of data
o Perform queries for data quality control and exportation to statistical packages for analysis

Ethical and Regulatory Issues in Clinical Research (Tuesdays, 9/5/06 - 10/24/06, 5:30 - 8:30 pm)
Participants will explore and examine the ethical issues central to clinical research, review the regulations of clinical investigation, and better appreciate the role of good clinical practices for clinical trials.
Upon completion of this course, participants will be able to:
o Incorporate modern ethical standards and regulatory requirements into the design of a clinical investigation
o Identify good clinical practices for clinical trials

Design of Clinical Studies (Mondays, 10/30/06 - 12/18/06, 5:30 - 8:30 pm)
Participants will learn the scientific methods applied in a clinical setting, frame a scientific question in quantitative terms, choose a clinical study design, collect and manage data, formulate statistical inferences about research questions, write a study protocol, and critically evaluate strengths and weaknesses of study designs.
Upon completion of this course, participants will be able to:
o Critically evaluate a clinical study that uses either observational or experimental designs
o Select a design for a clinical project, understanding the strengths and weaknesses of the selected design and its alternatives
o Write a brief protocol for a clinical study.

Quantitative Analysis of Clinical Data ((Mondays, 1/22/07 - 3/5/07, 5:30 - 8:30 pm)
Participants will learn the statistical approach to scientific inference, how to produce effective graphical and tabular displays of research information, and aspects of the design and analysis of data from observational and experimental clinical studies.
Upon completion of this course, participants will be able to:
o Read, understand and critically discuss quantitative methods used in the scientific literature on clinical investigation
o Analyze and interpret basic quantitative data

Outcomes and Effectiveness Research (Tuesdays, 3/20/07 - 5/08/07, 5:30 - 8:30 pm)
This course is designed to provide an overview of outcomes and effectiveness research. Students will explore the applications of methods for assessing patient outcomes of care in inpatient and managed care settings, and the arrangements and other factors on disease outcomes. The range of outcomes to be examined includes clinical/disease outcomes, functional status, quality of life, satisfaction, and cost outcomes. The course will explore conceptual modeling of treatment/outcomes relationships including decision analysis, the range of data sources, data collection strategies, statistical modeling, and application of the information including the use of systematic reviews.
Upon completion of this course, participants will be able to:
o Evaluate outcomes and effectiveness research
o Understand the tools they can use to conduct outcomes and effectiveness research



 Up to 21 CME Credits21-24 CME Credits
Physicians and Allied Health Professionals $1374$2060
Johns Hopkins Post-doctoral Fellows*
*with verification of status

Registration is limited. Register early to ensure your space.
REGISTRATION CUT-OFF DATE -- 5 days prior to activity
Methods of Payment: By credit card or check prior to the activity. On-site payments by credit card only. We cannot accept cash.
Payment must accompany registration form. A $50 late fee applies to registrations received later than 5 business days prior to activity starting date. Foreign payments must be by credit card or with a U.S. Dollar World Money Order. The registration fee includes instructional materials and refreshments.
You will receive a confirmation by e-mail if you have provided your e-mail address. Otherwise confirmation will be sent by mail. If you have not received it by the 5th business day prior to the course, call (410) 955-3169 to confirm that you are registered. Certificates of attendance will be mailed within 45 days of the completion of the course.
The Johns Hopkins University reserves the right to cancel or postpone any activity due to unforeseen circumstances. In this event, the University will refund the registration fee but is not responsible for travel expenses.

Refund policy: A handling fee of $50 is deducted for cancellation. Refund requests must be received by fax or mail no later than 5 days before the course start date. No refunds will be made thereafter. Transfer of registration to another Johns Hopkins conference in lieu of cancellation is not possible.

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Americans with Disabilities Act

The Johns Hopkins University School of Medicine fully complies with the legal requirements of the ADA and the rules and regulations thereof. Please notify us if you have any special needs.

Faculty will include:

N. Franklin Adkinson, Jr, MD
Director, Graduate Program in Clinical
Professor of Medicine

Josef Coresh, MD, PhD
Professor of Epidemiology, Medicine and

Gregory B. Diette, MD, MHS
Associate Professor of Medicine and

Norman Fost, MD, MPH
Professor of Pediatrics
Chair, University of Wisconsin IRB and Ethics

Steven N. Goodman, MD, PhD
Associate Professor of Oncology, Biostatistics
and Epidemiology

Christian Merlo, MD, MPH
Department of Medicine

Steven Piantadosi, MD, PhD
Professor of Medicine
Associate Professor of Oncology and

Naresh M. Punjabi, MD, PhD
Associate Professor of Medicine

John W. Robinson, MD, PhD
Faculty Associate

Jonathan M. Samet, MD, MS
Professor and Chairman of Epidemiology

Scott L. Zeger, PhD
Professor and Chairman of Biostatistics

Johns Hopkins University
Bloomberg School of Public Health
615 N. Wolfe Street, Room 2030 West
Baltimore, Maryland

The Bloomberg School of Public Health is located at 615 N. Wolfe Street, directly across from the Johns Hopkins Hospital, in East Baltimore. Parking is available in the Washington Street Garage, located on Washington Street just north of Monument Street. The School of Public Health is a short walk west on Monument. Complete directions, along with a map of the Johns Hopkins Medical Institutions, will be mailed with your confirmation notice.

Johns Hopkins is smoke-free.

For further travel information and tips, click here.
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