Agenda

Clinical Research Professional Certification Preparation and GCP Review Course

*All times are in Eastern Time Zone


DAY 1

12:00 - 12:10 Introduction / Agenda / Certification Program

12:10 - 1:05 Basic Concepts of Compliance

1:05 - 1:15 Questions 

1:15 – 2:05 Drug Development

2:05 – 2:20 Break

2:20 – 2:30 Phases of Development

2:30 - 3:15 Device Development

3:15 - 3:45 Prominent Regulations/Ethics

3:45 - 4:00 Questions


DAY 2

12:00 - 1:00 GCP Roles & Responsibilities

1:00 - 1:50 Informed Consent/Common Rule

1:50 - 2:05 Break

2:05 - 2:20 IRBs

2:20 - 2:50 Planning and Coordinating Clinical Trials

2:50 - 3:00 Questions

3:00 - 3:20 Safety Reporting, Study Closure and Record Retention

3:20 - 3:50 Audits/Inspections 

3:50 - 4:00 Resources and Final Questions