Agenda
Clinical Research Professional Certification Preparation and GCP Review Course
*All times are in Eastern Time Zone
DAY 1
12:00-12:40 Introduction
Certification program
Topics of discussion
Pre-test Foundations of ethical research and abbreviations sheet
12:40 to 1:50 Basic Concepts of Compliance
Laws, regulations, guidances, standard operating procedures
1:50 – 2:00 Questions
2:00 – 2:15 Break
2:15 – 3:50 Drug & Device Development
Drug Development
Phases of Development
Device Development
3:50-4:00 Questions
DAY 2
12:00 to 1:00 GCP Roles & Responsibilities
Sponsor responsibilities
Monitor responsibilities
Investigator responsibilities
1:00 to 2:30 Prominent Regulations/Ethics
Informed consent
Institutional Review Boards
Financial disclosure
(2:00-2:15 Break)
2:30-2:40 Questions
2:40 to 3:50 Planning and Coordinating Clinical Trials
Safety reporting
Study closure
Record retention
Audits/Inspections
3:50 - 4:00 Questions