Events

Day 1 Sessions

Workshop Introduction - Polly Sager

Introduction to Epidemiology – Kenneth Schulz

The Role of Biostatistics – Mario Chen

Protecting Human Participants in Research: Historical and Ethical Perspectives – Jeremy Sugarman

Ethics in the Design of Clinical Research – Jeremy Sugarman

Primary Research Question and Definition of Endpoints – Mario Chen

Writing a Protocol – Deborah Hilgenberg

Day 2 Sessions

ICH GCP– Michelle Immelman

The Informed Consent Process – Jeremy Sugarman

Role of Institutional Review Boards (IRBs) – Jeremy Sugarman

Essential Documents and Source Documents – Michelle Immelman

Safety Oversight Guidelines – Mario Chen

Practical Considerations for Fielding a Research Study – Deborah Hilgenberg

Day 3 Sessions

Analytic Study Design – Kenneth Schulz

Sample Size Determination – Mario Chen

Day 4 Sessions

Critical Elements of Randomized Trials – Kenneth Schulz

Development of Analysis Plans – Mario Chen

Data Management Plans – Patrick Murphy

GCP Requirements for IRBs – Michelle Immelman  

Lab Samples and Tracking – Patrick Murphy

SOPs, WIs and Forms – Patrick Murphy

Day 5 Session

Quality Control/Quality Assurance – Michelle Immelman  

Retention in Prospective Studies– Kenneth Schulz

Case Report Form (CRF) Design  - Patrick Murphy

GCP Requirement for Informed Consents – Michelle Immelman

Understanding Adverse Events – Deborah Hilgenberg 

If Research is Not Published,  It Did Not Happen – Ken Schulz

Clinical Site Monitoring - Michelle Immelman

What is the ICSSC? – Michelle Immelman

Other Materials

NIAID Oversight of Clinical Research & Funding Opportunities-NIH Clinical Terms of Award and Funding Opportunities - Polly Sager

Supplemental Materials (6.5MB file)