*All times are in Eastern Time Zone
12:00 - 12:10 Introduction
12:10 - 12:20 Disclosure of Relationships and Declaration
Certification Program
Exam Content
Prep Course Agenda
12:20 - 12:40 Pretest Exercise
12:40 - 1:05 Study Start-Up
Ethical Foundations
1:05 - 1:30 Study Start-Up
Overview of Research Regulations
1:30 - 1:45 Break
1:45 - 2:45 Study Start-Up
Drug Development and Trial Design
Investigational New Drug Application
Expanded Access
2:45 - 3:30 Study Start-Up
Device Development
3:30 - 3:45 Conduct of Study
Clinical Protocols
Sponsor Responsibilities
3:45 - 4:00 Final Q&A
12:00 - 12:45 Conduct of Study
Sponsor Responsibilities
Investigator and Monitor Responsibilities
Financial Disclosure
12:45 - 1:10 Conduct of Study
Institutional Review Board
1:10 - 2:10 Conduct of Study
Informed Consent
2:10 - 2:25 Break
2:25 - 3:05 Conduct of Study
Managing Study Compliance
Safety Reporting
3:05 - 3:10 Study Close-Out
Study Closure/Record Retention
3:10 - 3:35 Conduct of Study
Inspections and Audits
3:35 - 4:00 Resources and Final Questions