Introduction

Monday, October 27th
Session 1

Welcome (30 minutes)
John I. Gallin, M.D.
Director, NIH Clinical Center

Unit 1: History of Clinical Research and Choosing a Research Question (30 minutes)
John I. Gallin, M.D.
Director, NIH Clinical Center

Module I, Statistical Methods

Tuesday, October 28th
Session 2

Unit 2: Participant Selection (45 minutes)
Tamara Harris, M.D., M.S.
Chief, Geriatric Epidemiology Section, NIA

Unit 3: Using Secondary Data and Meta Analysis (45 minutes)
Tamara Harris, M.D., M.S.
Chief, Geriatric Epidemiology Section, NIA

Monday, November 3rd
Session 3

Unit 4: Design of Epidemiologic Studies (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Tuesday, November 4th
Session 4

Unit 5: Study Development (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Monday, November 10th
Session 5

Unit 6: Economic Analysis in Clinical Research (1.5 hours)
Martin Brown, Ph.D.
Chief, Health Services and Economics Branch, NCI

Tuesday, November 11th

Federal Holiday - No Class

Tuesday, November 17th
Session 6

Unit 7: Measures (1 hour)
David Black, Ph.D.
Psychologist
Pediatric and Development Neuropsychiatry, NIMH

Tuesday, November 18th
Session 7

Unit 8: Issues in Randomization (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Thursday, November 20th, 
Session 8

Breakout Session (1 Hour)
Title - TBD
Laura Lee Johnson, PhD.
Statistician, Office of Clinical Regulatory Affairs, NCCAM

Monday, November 24th

NO CLASS

Tuesday, November 25th

NO CLASS

Monday, December 1st 
Session 9

Unit 9: Overview of Hypothesis Testing (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Tuesday, December 2nd 
Session 10

Unit 10: Sample Size and Power (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Thursday, December 4th
Session 11

Breakout Session (1 hour)
Title: TBD
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Monday, December 8th
Session 12

Unit 11: Conceptual Approach to Survival Analysis (1.5 hours)
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Tuesday, December 9th
Session 13

Unit 12: Designing and Testing Questionnaires (1 hour)
Jack Guralnik, M.D., Ph.D.
Chief, Epidemiology and Demography Section, NIA

Thursday, December 11th
Session 14

Breakout Session (1 hour)
Title: TBD
Laura Lee Johnson, Ph.D.
Statistician, Office of Clinical and Regulatory Affairs, NCCAM

Monday, December 15th
Session 15

Unit 13:  Opportunities for Innovation in Clinical Research: From Molecule to Medicare - Part I (45 minutes)
Mitchell Max, M.D.
Director, Molecular Epidemiology of Pain Program
Professor of Anesthesiology, Medicine, and Human Genetics
University of Pittsburgh

Unit 14: Opportunities for Innovation in Clinical Research: From Molecule to Medicare - Part II (45 minutes)
Joanne Lynn, M.D.
Medical Officer
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services, HHS

Module II, Ethical Issues and Regulation of Human Subjects Research

Tuesday, December 16th
Session 16

Unit 1: Researching an Ethics Question (45 minutes)
Ezekiel Emanuel, M.D., Ph.D.
Chief, Bioethics Department, CC

Unit 2: Ethical Principles in Clinical Research (45 minutes)
Christine Grady, R.N., Ph.D.
Head, Section on Human Subjects Research
Bioethics Department, CC

Monday, December 22

NO CLASS

Tuesday, December 23

NO CLASS

Monday, December 29th

NO CLASS

Tuesday, December 30th 

NO CLASS

Monday, January 5th
Session 17

Unit 3: Legal Issues in Clinical Research (45 minutes)
Valerie Bonham, J.D.
Senior Attorney
Office of General Council, NIH

Unit 4: Concepts in the Management of Projects (1 hour)
Charles Grudzinskas, Ph.D.
Principal, NDA Partners LLC and Adjunct Professor
Georgetown University Medical Center

Tuesday, January 6th
Session 18

Breakout Session:
Mock IRBs (2 hours)
Julia Slutsman, Ph.D.
Health Science Policy Analyst
Office of Human Subjects Research, NIH

Thursday, January 8th
Session 19

Breakout Session:
Legal Issues in Clinical Research (1 hour)
Patricia Kvochak, J.D.
Deputy NIH Legal Advisor, NIH

Monday, January 12th
Session 20

Unit 5: Evaluation of a Protocol Budget (1.5 hours)
Margaret Matula, R.N., B.S.N., M.G.A.
Director, Research and Clinical Trials
Anne Arundel Medical Center

Tuesday, Tuesday, January 13th
Session 21

Unit 6: Special Lecture:
Human Genome Project and Clinical Research (1 hour)
Christopher Austin, M.D.
Senior Translation Research Advisor to the Director, NHGRI

Monday, January 19th

Federal Holiday No Class

Tuesday, January 20th

Federal Holiday No Class

Monday, January 26th
Session 22

Unit 1: FDA Product Regulation (1.25 hours)
Robert Yetter, Ph.D.
Associate Director for Review Management
Center for Biologics Evaluation and Research, FDA

Tuesday, January 27th
Session 23

Unit 2: The Clinical Researcher and the Media (45 minutes)
John Burklow, M.S.
Associate Director for Communications
Office of Communications and Public Liaison, NIH

Unit 3: Product Development: Moving from the Bench to the Clinic (45 minutes)
Richard Schwartz, PhD.
Chief, Vaccine Production Program Lab
Vaccine Research Center/NIAID/NIH

Monday, February 2nd 
Session 24

Unit 4: Data and Safety Monitoring Boards (1 hour)
Dennis O. Dixon, Ph.D.
Mathematical Statistician
Biostatistics Research Branch, NIAID

Tuesday, February 3rd 
Session 25

Unit 5: Data Management in Clinical Trials (1 hour)
Diane St. Germain, R.N., M.S., C.R.N.P.
Nurse Consultant
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI

Monday, February 9th
Session 26

Unit 5: Quality Control in Clinical Trials (1 hour)
Jack Guralnik, M.D., Ph.D.
Chief, Epidemiology and Demography Section, NIA

Tuesday, February 10th
Session 27

Unit 7: Quality of Life (1 hour)
John Ware, Ph.D.
CEO and Chief Science Officer, Quality Metric, Inc.

Module lV, Preparing and Funding a Clinical Research Study

Monday, February 16th

Federal Holiday - No Class

Tuesday, February 17th
Session 28

Unit 1: Scientific Conduct (45 minutes)
Joan Schwartz, Ph.D.
Assistant Director
Offie of Intramural Research, NIH

Monday, February 23th
Session 29

Unit 2: NIH Peer Review Process (45 minutes)
Olivia Bartlett, Ph.D.
Chief, Research Programs Review, NCI

Tuesday, February 24th
Session 30

Unit 3: Information Resources for Clinical Research (45 minutes)
Josh Duberman, M.L.I.S.
Informationist/Research Librarian

Monday, March 2nd
Session 31

Unit 4: Clinical Research from the Patient's Perspective (1 hour)
Susan Butler, B.A., M.A.
Vice President, Ovarian Cancer National Alliance

Tuesday, March 3rd
Session 32

Unit 5: Design of Case Report Forms (1 hour)
David Mailhot, B.S., M.P.H.
Director, Global Research and Development
Global Clinical Data Services
Pfizer Global Research and Development

Monday, March 9th
Session 33

Unit 6: ProtoType and Protocol Mechanics (1 hour)
Philip Lightfoot, B.S., B.A.
Systems Analysis, DCRI, CC

Tuesday, March 10th
Session 34

Unit 7: Technology Transfer - Part 1 (1.5 hours)
Bruce Goldstein, J.D.
Unit Coordinator, Technology Transfer Branch, NCI

Monday, March 16th
Session 35

Unit 8: Inclusion of Women and Minorities in Clinical Trials (45 minutes)
Miriam Kelty, Ph.D.
Former Associate Director, Extramural Activities, NIA

Tuesday, March 17th 
Session 36

Unit 9: Evaluation of Alternative and Complementary Therapies (1 hour)
Marc Blackman, M.D.
Associate Chief of Staff for Research and Development
Veteran’s Administration Medical Center