HOW TO COORDINATE CLINICAL TRIALS: THE BASICS
HOW TO COORDINATE CLINICAL TRIALS: BEYOND THE BASICS
HOW TO MANAGE CLINICAL
TRIAL FINANCES
©1999-2008 text content and graphics for this site, Clinical Research Site Training (CRST)

 
AVAILABLE FOR ON- SITE TRAINING
SAMPLE AGENDA: INVESTIGATOR BASICS

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



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