Attendees will be able to describe the responsibilities of a principal investigator, understand the requirements they must follow when conducting a clinical study, understand how responsibilities may be delegated to other study personnel with proper oversight, and recall common warning letter findings. The PI Package includes our signature FAIR Shake(TM) technique, which teaches the learner to take an otherwise complicated maze of requirements and break them down into four simple areas that can be applied to solving clinical research questions. Attendees will understand how to protect research subjects and how and when to report adverse events.
Review FDA regulations and ICH GCP E6 Guideline for Good Clinical Practice (GCP)
Describe Investigator responsibilities in the context of study protocol oversight and GCP compliance
Recognize critical elements of human subject protection
Discuss the requirements for investigational product management and maintenance of adequate and accurate records
Recognize key requirements for patient safety management and regulatory reporting
Examine recent trends in non-compliance and BIMO Inspections
AGENDA 8:00 am - 5:00 pm
Introduction to Good Clinical Practice: ICH GCP Guidelines
Introduction to the U.S. FDA Regulations for Clinical Research
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
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
High Quality Documentation and Study Records
Source Documentation
Adverse Event Classification and Reporting
Investigational Product Accountability
Hosting Sponsor Monitors and Auditors
Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites
Day In The Life of an Effective Principal Investigator: Best Practices
TYPE
• In Person Training - At IMARC or Your Location
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
ADDITIONAL WEB-BASED COURSE ADD-ONS
History of Clinical Research
Critical Thinking in Clinical Research
Monitoring Overview
Maintaining the Sponsor TMF
Introduction to Risk-Based Monitoring
FDA Inspectional Findings
• New or current investigators who need training on their research responsibilities
