Introduction to the Principles and Practice of Clinical Research
A Teleconference from the NIH
NOTE: The times listed here are Dallas times. The teleconference will be broadcast live from the NIH in D1.502.
Textbook: Principles and Practice of Clinical Research, John I, Gallin, ed. Academic Press, New York, 2002
Date Day of Week
Time (Dallas)
Lecturer
Lecture Title
20-Oct Monday
4:00 p.m. - 4:30 p.m.
Gallin
Welcome and a Historical Perspective
4:30 p.m. - 5:00 p.m.
Gallin
Choosing a Research Question
MODULE I: EPIDEMIOLOGIC METHODS
21-Oct Tuesday
4:00 p.m. - 4:45 p.m.
Harris
Participant Selection
4:45 p.m. - 5:30 p.m.
Harris
Using Secondary Data and Meta Analysis
27-Oct Monday
4:00 p.m. - 5:30 p.m.
Manolio
Design of Epidemiologic Studies
28-Oct Tuesday
4:00 p.m. - 5:00 p.m.
Manolio
Study Development
3-Nov Monday
4:00 p.m. - 5:00 p.m.
Designing and Testing Questionnaires
4-Nov Tuesday
4:00 p.m. - 5:30 p.m.
Brown
Economic Analysis in Clinical Research
10-Nov Monday
4:00 p.m. - 5:00 p.m.
Pine
Measures
11-Nov Holiday
VETERAN'S
DAY
17-Nov Monday
4:00 p.m. - 5:30 p.m.
Johnson
Issues in Randomization
18-Nov Tuesday
4:00 p.m. - 5:00 p.m.
Straus
Special Lecture: Unanticipated Risk in Clinical Research
24-Nov Monday
RECESS
25-Nov Tuesday
RECESS
1-Dec Monday
4:00 p.m. - 5:30 pm.
Johnson
Overview of Hypothesis Testing
2-Dec Tuesday
4:00 p.m. - 5:30 p.m.
Johnson
Sample Size and Power
8-Dec Monday
4:00 p.m. - 5:30 p.m.
Johnson
Conceptual Approach to Survival Analysis
9-Dec Tuesday
4:00 p.m. - 5:30 p.m.
Max and Lynn "Opportunities
for Innovation in Clinical Research:
From Molecule
to Medicare"
15-Dec Monday
4:00 p.m. - 5:00 p.m.
Burklow
The Clinical Researcher and the Media
MODULE II : ETHICAL ISSUES IN HUMAN SUBJECTS RESEARCH
16-Dec Tuesday
4:00 p.m. - 4:45 p.m.
Grady
Ethical Principles in Clinical Research
4:45 p.m. - 5:30 p.m.
Emanuel
Researching an Ethics Question
22-Dec Monday
RECESS
23-Dec Tuesday
RECESS
29-Dec Monday
RECESS
30-Dec Tuesday
RECESS
5-Jan Monday
4:00 p.m. - 4:45 p.m. Schwartz
Scientific
Conduct
4:45 p.m. - 5:30 p.m. Kvochak
Legal
Issues in Clinical Research
6-Jan Tuesday
4:00 p.m. - 6:00 p.m.
Wichman and Abbott Breakout Session: Mock IRBs
8-Jan Thursday
4:00 p.m. - 5:00 p.m.
Kvochak
Breakout Session: Legal Issues in Clinical Research
MODULE III: MONITORING PATIENT-ORIENTED RESEARCH AND REGULATORY ISSUES
12-Jan Monday
4:00 p.m. - 4:45 p.m. Ferris
Data and Safety Monitoring Boards
4:45 p.m. - 5:30 p.m. Manolio
Quality Control in Clinical Trials
13-Jan Tuesday
4:00 p.m. - 5:00 p.m. Butler
Clinical Resesearch from a Patient's Perspective
19-Jan Holiday
MLK
JR. DAY
20-Jan Tuesday
4:00 p.m. - 5:00 p.m. Zoon
FDA Product Regulation
20-Jan
Gomez
Product
Development: Moving from
the Bench to the Clinic
26-Jan Monday
4:00 p.m. - 4:45 p.m. Hann
Inclusion of Women and Minorities in Clinical Trials
4:45 p.m. - 5:30 p.m. Tompkins
Data Management
in Clinical Trials
27-Jan Tuesday
4:00 p.m. - 5:00 p.m. Austin
Human Genome Project and Clinical Research
MODULE IV: PREPARING AND FUNDING A CLINICAL RESEARCH STUDY
2-Feb Monday
4:00 p.m. - 5:30 p.m. Matula
Evaluation of a Protocol Budget
3-Feb Tuesday
4:00 p.m. - 5:00 p.m. Preble-Bartlett
NIH Peer Review Process
5-Feb Thursday
4:00 p.m. - 5:00 p.m. Preble-Bartlett
Breakout Session: NIH Peer
Review Process
9-Feb Monday
4:00 p.m. - 5:00 p.m. Ware
Quality of Life
10-Feb Tuesday
4:00 p.m. - 4:45 p.m. Nussenblatt
Prototype
and Protocol Mechanics
16-Feb Monday
Holiday
Design of Case Report Forms
17-Feb Tuesday
4:00 p.m. - 4:45 p.m. Spiegel
Technology Transfer - Part I
4:45 p.m. - 5:30 p.m. Goldstein
Technology
Transfer - Part II
23-Feb Monday
4:00 p.m. - 5:00 p.m. Grudzinskas
Concepts in the Management
of Projects
Mailhot
Design of Case Report Forms
24-Feb Tuesday
4:00 p.m. - 5:00 p.m. Blackman
Evaluation
of Alternative and Complementary Therapies