Agenda

Clinical Research Professional Certification Preparation and GCP Virtual Review Course


Central Time Zone

8:00 to 8:05

Introduction - Disclosure of Relationships

8:05 to 8:35

Study Start-Up: Ethical Foundations 

8:35 to 9:00

Study Start-Up: Overview of Research Regulations 

9:00 to 9:15

Break

9:15 to 10:15     

Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access; Post Market Surveillance

10:15 to 10:45

Study Start-Up: Device Development

10:45 to 11:30

Conduct of Study: Clinical Protocols; Sponsor Responsibilities

11:30 to 1:00

Lunch (on your own)

1:00 to 1:40

Conduct of Study: Investigators and Monitors Responsibilities; Financial Disclosure

1:40 to 2:25

Conduct of Study: Institutional Review Board (IRBs)

2:25 to 3:10

Conduct of Study: Informed Consent

3:10 to 3:20

Break

3:20 to 3:50

Conduct of Study: Managing Study Compliance; Safety Reporting

3:50 to 4:30

Study Close-Out: Study Closure/Record Retention; Regulatory Submission 

4:30 to 4:50 

Conduct of Study: Inspections and Audits 

4:50 to 5:00

Resources and Final Questions