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AIMR PI-READY CERTIFICATION


Content
  • Module 1: The Role of the Principal Investigator
  • Scene 1 – Introduction: The Foundation of Trust
  • Scene 2 – Personal Accountability and Regulatory Obligation
  • Scene 3 – Delegation and Supervision
  • Scene 4 – Oversight in Daily Practice Content unit
  • Scene 5 – Data Integrity and Documentation
  • Scene 6 – The PI as a Leader
  • Scene 7 – Summary and Key Takeaways Content unit
  • Knowledge Check – Module 1
  • Module 2: Ethics and Regulatory Foundations
  • Scene 1 – Introduction: The Moral Backbone of Research Content unit
  • Scene 2 – The Belmont Principles
  • Scene 3 – Good Clinical Practice (GCP) and the Investigator’s Role
  • Scene 4 – The Institutional Review Board (IRB) and Ongoing Oversight
  • Scene 5 – Informed Consent as a Continuous Process Content unit
  • Scene 6 – Scenario: Ethics in Practice
  • Scene 7 – Summary and Key Takeaways
  • Knowledge Check – Module 2
  • Module 3: Study Startup and Oversight
  • Scene 1 – Introduction: Building the Foundation for Success
  • Scene 2 – Site Qualification and Feasibility
  • Scene 3 – Core Startup Documentation
  • Scene 4 – Delegation of Duties and Supervision Planning
  • Scene 5 – Site Initiation and Readiness
  • Scene 6 – Oversight After Startup
  • Scene 7 – Scenario: Startup in Practice
  • Scene 8 – Summary and Key Takeaways
  • Knowledge Check – Module 3
  • Module 4: Conduct and Documentation
  • Scene 1 – Introduction: Execution Defines Integrity
  • Scene 2 – Source Data and the ALCOA+ Principles
  • Scene 3 – Protocol Adherence and Deviation Management
  • Scene 4 – Source Documentation and Case Report Forms (eCRFs)
  • Scene 5 – Monitoring Visits and Communication
  • Scene 6 – Scenario: When Documentation Tells a Different Story
  • ​Scene 7 – Summary and Key Takeaways
  • Knowledge Check – Module 4
  • Module 5 – Safety and Reporting (Updated)
  • Scene 1 – Introduction: The Investigator as the Safety Gatekeeper
  • Scene 2 – Definitions: AE, SAE, and UPIRTSO
  • Scene 3 – Causality, Severity, and Expectedness
  • Scene 4 – Reporting Timelines and Responsibilities
  • Scene 5 – The Investigator’s Role in Risk Management
  • Scene 6 – Scenario: Missing the Signal
  • Scene 7 – Unanticipated Problems and Re-Consent
  • Scene 8 – Documentation of Safety Oversight
  • Scene 9 – Summary and Key Takeaways
  • Knowledge Check – Module 5
  • Module 6: Quality, Audits, and Inspections
  • Scene 1 – Introduction: Quality Is Not a Department
  • Scene 2 – The Continuum of Oversight: Monitoring, Auditing, and Inspection
  • Scene 3 – Common Findings and Their Root Causes
  • Scene 4 – Corrective and Preventive Actions (CAPA)
  • Scene 5 – Inspection Readiness: Culture and Practice
  • Scene 6 – Scenario: The Audit Surprise
  • Scene 7 – Summary and Key Takeaways
  • Knowledge Check – Module 6
  • Module 7 – Leadership, Communication, and Continuous Learning
  • Scene 1 – Introduction: The PI as Cultural Architect
  • Scene 2 – Leadership Behaviors that Build Trust
  • Scene 3 – Communication: The Antidote to Error
  • Scene 4 – Managing Conflict and Feedback
  • Scene 5 – Developing Others
  • Scene 6 – Continuous Learning and Professional Growth
  • Scene 7 – Scenario: The Tone You Set
  • Scene 8 – Summary and Key Takeaways
  • Knowledge Check – Module 7
  • Final Exam – “Investigators in Practice
  • Exam Overview/Final Examination Question
Completion rules
  • All units must be completed
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