This one-day course provides an excellent introduction to clinical research and CRC job responsibilities. New or aspiring clinical research coordinators (CRCs) will be introduced to regulations, best practices, and their roles and responsibilities within a clinical trial.
Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCPs)
Describe the roles and responsibilities of the Clinical Research Coordinator, Principal Investigator, and Sponsor (PM and CRA)
Review the different types of Monitoring Visits, including preparation, conduct, documentation and follow-up
Describe definitions related to safety management, identification of adverse events, and reporting requirements
Recall the elements of the FAIR ShakeTM Method, apply the method to potential compliance concerns, and understand the importance of
supporting recommendations with the FAIR ShakeTM Method.
Identify best practices and skills to be an effective research coordinator
AGENDA 8:30 am - 4:30 pm
21 CFR Parts 312, 812, 50, 56, 54, and 11
INDs vs IDEs: Comparing 21 CFR Parts 312 and 812
Human Subject Protection
Drilling Down 21 CFR Part 50: Conducting and Documenting Proper Informed Consent
Protecting Subject Protected Health Information (PHI): HIPAA and HITECH
The FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
Key Roles and Responsibilities in Clinical Research Overview
Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager, and Statistician
Source Documentation
Adverse Event Classification and Reporting
Investigational Product Accountability
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
Clinical Research Coordinators with limited experience in managing industry-sponsored studies
Experienced Coordinators seeking to review the fundamentals of clinical research regulations
