Event Calendar

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