Example: Investigator Basics

The Investigator role in a trial has a unique perspective. We have adapted the “Basics” workshop to meet those needs.

Sample Agenda

Day 1:

Why is This Workshop Important?

• Impact on you
• Impact on your staff
• Impact on your subjects
• Impact on your practice

Regulatory Background

• Drug development update
• Good Clinical Practice: FDA v/s ICH

Defining the Scope of Your Role

• The 1572
• Doing v/s delegating
• All that paper--trial documents
• You and the IRB

Day 2

Carrying Out Your Role: Informed Consent

• Document design and content
• Delivery process dual approach

Your Other Responsibilities

• Document storage
• Reporting serious or unexpected events
• Drug accountability
• Working with monitors

Managing Risks

• Protocol/budget analysis
• Financial disclosure
• FDA audits