9/24/2018-Course #340.655-REVISED

Sponsored by the WelchCenter for Prevention, Epidemiology & Clinical Research, the General Clinical ResearchCenters, and the Graduate Training Program in Clinical Investigation

INTRODUCTION TO CLINICAL RESEARCH: A TWO-WEEK INTENSIVE COURSE

JohnsHopkinsUniversitySchool of Medicine

WelchCenter for Prevention, Epidemiology and Clinical Research

2024 E. Monument Street; Suite 1-500Q

MONDAY
July 9 / TUESDAY
July 10 / WEDNESDAY
July 11 / THURSDAY
July 12 / FRIDAY
July 13
9:00 am / o INTRODUCTION
o Pre-Test
M. Klag / o Study Design: Case Reports
and Case Series
M. Klag / o Study Design: Case-Control
Studies
HC-Chapter 8
M. Klag / o Data Gathering and
Questionnaire Development
HC-Chapter 15
M. Klag / o Study Design: Clinical
Trials I and II
HC-Ch. 10
F. Brancati
10:00 am / o Defining the Research
Question
HC-Ch. 1,2
M. Klag / o Study Design: Cross-sectional
Studies
HC-Ch. 8
M. Klag / o Study Design: Case-Control
Studies
HC-Ch. 8
M. Klag / o Study Design:
Prospective Studies
HC-Chapter 7
F. Brancati / o Study Design: Clinical
Trials III
HC-Ch. 11
F. Brancati
11:00 am / o Measurement of Rates
and Risks
M. Klag / o Statistics: Comparing Means
(Z and t Tests)-I
DT-Chapter 5 (except 5.4 & 5.9)
E. Guallar / o Statistics: Proportions I
DT-Ch. 5.4
E. Guallar / o Statistics: Proportions II
DT-Ch. 6.3
E. Guallar / o Statistics: Sample Size
DT-Chapter 5.9, 6.4
E. Guallar
12:00 / LUNCH / LUNCH / LUNCH / LUNCH / LUNCH
1:30 pm / o Statistics: Describing
Data and Making
Inferences
DT-Ch. 1-3
E. Guallar / o Statistics: Comparing Means
(Z and t Tests)-II
DT-Ch. 6.1,6.2
E. Guallar / o Searching the Literature
Claire Twose / o Principles of Drug
Development
C. Flexner / o Managing Your Own Data
(...If You Have To)
HC-Ch. 16
K. Carson
2:30 pm / o Statistics: Precision and
Confidence Intervals I
DT-Ch. 4
E. Guallar / SEE SMALL GROUP LISTINGS FOR ROOM ASSIGNMENTS
3:00pm-4:30 Small Groups / 3:00pm-4:30 Small Groups / 3:00pm-4:30 Small Groups / 3:00pm-4:30 Small Groups
3:30 pm / o Statistics: Precision and
Confidence Intervals II
DT-Ch. 4
E. Guallar

HC - Hulley,Cummings, et al; DT - Dawson, Trapp

REVISED – 7/12/2007

INTRODUCTION TO CLINICAL RESEARCH: A TWO-WEEK INTENSIVE COURSE

JohnsHopkinsUniversitySchool of Medicine

WelchCenter for Prevention, Epidemiology and Clinical Research

2024 E. Monument Street; Suite 1-500Q

MONDAY
July 16 / TUESDAY
July 17 / WEDNESDAY
July 18 / THURSDAY
July 19 / FRIDAY
July 20
9:00 am / o Ethical Issues of Clinical
Research
HC-Ch. 14
N. Kass / o Analyzing Multiple Variables I
DT-Ch. 8
S. Goodman / o Mentoring
J. Clark / o The Anatomy of a Paper
M. Klag / 9:00- 9:30
POST-TEST
10:00 am / o Evaluation of Diagnostic
Tests and Screening I
HC-Ch. 12
S. Goodman / o Analyzing Multiple Variables II
DT-Ch.10 (except 10.4)
S. Goodman / o Statistics: Prediction /Prognostics Models
DT-10.4
S. Goodman / o Overview: How to Choose the
Appropriate Statistical Method
S. Goodman / PRESENTATIONS
Presentations by small
groups will begin at 9:45
and are to be15 minutes in
length (10 minutes for presentation; 5 minutes for questions)
11:00 am / o Evaluation of Diagnostic
Tests and Screening II
HC-Ch.12
S. Goodman / o Institutional Review Board
D. Ford / o Funding Your Research the
Easy Way: The GCRC
J. Coresh / o Dealing with Medical
Journals
S. Goodman
12:00 / LUNCH / LUNCH / LUNCH / LUNCH / LUNCH
1:30 pm / o Statistics: Survival
Analysis
DT-Ch.9, 10.5
E. Guallar / o Research Funding and
Career Development
HC-Ch.19
M. Amey / o Systematic Reviews/Meta-
analysis
HC-Ch.13
S. Goodman / o How to Publish Your Data
S. Goodman / Presentations by Small
Groups, continued
Review of Post-test
3:00 / o Small Group Meeting / o Small Group Meeting / o Small Group Meeting / o Small Group Meeting

HC - Hulley,Cummings, et al; DT - Dawson, Trapp