Agenda

Clinical Research Professional Certification Preparation and GCP Virtual Review Course


*All times are in Eastern Time Zone


DAY 1

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

12:10 - 12:20 Certification Program, Exam Content, Prep Course Agenda

12:20 - 12:40 Pretest Exercise

12:40 - 1:05 Basic Concepts of Compliance, Code of Federal Regulations, 45 CFR 46, ICH E6 (R2)

1:05 - 1:25 Ethical Concepts that Guide GCP Regulations

1:25 - 1:45 Prominent GCP Regulations Roles and Responsibilities - Sponsors & Monitors

1:45 - 2:00 Break

2:00 - 2:30 Prominent GCP Regulations Roles and Responsibilities - Monitors & Investigators

2:30 - 3:30 Drug Development, Phases of Development, IND and NDA

3:30 - 4:00 Questions


DAY 2

12:00 - 12:45 Medical Device Development, IDE, PMN and PMA

12:45 - 1:30 Informed Consent (21 CFR 50)

1:30 - 1:45 Institutional Review Boards (21 CFR 56)

1:45 - 2:00 Break

2:00 - 2:30 Planning and Coordinating Clinical Trials

2:30 - 3:05 Records and Reports, Study Closure, Record Retention

3:05 - 3:35 Audits/Inspections

3:35 - 3:45 Resources

3:45 - 4:00 Final Questions