Events

Day

Session

Presenter

Tuesday, October 30

Workshop Introduction

Robin Mason

What is the ICSSC?

Michelle Immelman

Beginning with the End in Mind

Kenneth Schulz

The Role of Biostatistics

Mario Chen

ICH and Good Clinical Practices (GCP)

Michelle Immelman

Primary Research Question: Definition of Endpoints

Mario Chen

Design of Observational and Experimental Clinical Studies:  Choosing Your Study Design

Kenneth Schulz

Writing a Protocol:  From Concept to IRB-Ready

Deborah Hilgenberg

Wednesday, October 31

Ethics in the Design of Clinical Research

Jeremy Sugarman

Sample Size Determination

Mario Chen

Group Exercise:Sample Size Determination

Ken Schulz

The Informed Consent Process

Jeremy Sugarman

Role of Institutional Review Boards (IRBs)

Jeremy Sugarman

Thursday, November 1

Special Features of Randomized Controlled Trials

Kenneth Schulz

Data and Safety Monitoring Boards

Mario Chen

Practical Considerations for Fielding a Research Study

Deborah Hilgenberg

Introduction and Role of OCRA

Walt Jones

Retention of Study Participants

Kenneth Schulz

Source and Regulatory Documentation

Walt Jones

Safety Oversight Guidelines

Walt Jones

If Research is Not Published, It Did Not Happen

Kenneth Schulz

Addressing Safety Issues in Protocol Development

Walt Jones

GCP Discussion:
Protocols (ICH Section 6)
Statistics (ICH Section 6.9)
Informed Consent (ICH Section 4.8)
Review by IRB’s (ICH Section 5.10 & 5.11)
Independent Data Monitoring Committee (ICH 4.9.1,2,3)

Michelle Immelman

Friday, November 2

Understanding Adverse Events

Deborah Hilgenberg

Study Monitoring – What to Expect

Walt Jones

Principles of Data Management

Mario Chen

GCP Discussion:
Safety Reporting (ICH Section 4.11)
QA /QC (ICH Section 5.1
DM (ICH Section 5.5)
Monitoring (ICH Section 5.18)

Michelle Immelman