Certified Principal Investigator (CPI) Certification Prep Course

All Levels

0 (0 Ratings)

Categories Physicians

Description

Prepare for the CPI certification with essential knowledge, skills, and strategies for effective research leadership in healthcare.

Course Curriculum

Program Overview

Student Learning Objectives
Certified PI Program Overview
CSRS Program Policies & Enrollment
CSRS Acknowledgment and Agreement
Program Structure, Career Advancement, Orientation, & Learner Support

Chapter 1: Principal Investigator Foundations & Oversight

Module 1: Principal Investigator Roles, Responsibilities, and Oversight Models

33:43
Module 1 Quiz: Principal Investigator Roles, Responsibilities, and Oversight Models
Module 2: Why CRIO Matters

02:38
Module 2A: CRIO OVERVIEW OF SANDBOX

19:46
Module 3A: eSource (Electronic Source Documentation)

11:13
Module 4: Investigator Checklists + ICH GCP Alignment Guidelines
Module 3B: Integrated Clinical Trial Management Systems (CTMS, eReg, Financials & Recruitment)

24:20
Module 5: FDA Form 1572: Purpose, Commitments, and Investigator Accountability

13:34
Module 6: Evolution of the PI Role in Modern Clinical Trials
Module 7: Application of ICH-GCP Principles in Complex Trials
Module 8: Investigator Oversight in Multidisciplinary Research Environments
Module 9: Investigator-Initiated vs Sponsor-Initiated Trials
Module 10: Legal and Ethical Accountability Under U.S. Federal Regulations (21 CFR Overview)
Module 11: IRB and Ethics Committee Processes (Domestic and International)
Module 12: Oversight of Investigational Product Storage, Accountability, and Dispensing
Module 13: Multicenter and Multinational Trial Leadership
Module 14: Financial Disclosure Responsibilities (21 CFR Part 54)

Chapter 2: Advanced Clinical Trial Design & Protocol Development

Module 1: Advanced Review of Trial Phases (Preclinical through Phase 4)
Module 2: Contemporary and Adaptive Trial Designs
Module 3: Advanced Protocol Development and Review
Module 4: IRB / Ethics Committee Requirements and Review Pathways
Module 5: Randomized Controlled Trial Design Principles
Module 6: Inclusion and Exclusion Criteria Development Across Populations
Module 7: Translational Research Protocol Design (Early-Phase Focus)
Module 8: Rare Disease and Orphan Drug Protocol Development
Module 9: Pediatric and Vulnerable Population Trial Design
Module 10: Medical Device Trial Design Considerations

Chapter 3: Documentation, Consent & Regulatory Records

Module 1: Informed Consent Process (ICH-GCP 4.8 – Educational Overview)
Module 2: Trial Management, Documentation, and Recordkeeping
Module 3: Electronic Records and Signatures (21 CFR Part 11 Overview)
Module 4: Essential Regulatory Documentation and Binder Organization
Module 5: Case Report Form Design Principles
Module 6: Investigator’s Brochure Review
Module 7: Trial Master File (TMF) and Industry Models
Module 8: Financial Disclosure and Conflict of Interest Management
Module 9: CRIO Training: eConsent & Regulatory Document Management

Chapter 4: Investigator Leadership & Team Management

Chapter 5: Monitoring, Site Visits & Audits

Chapter 6: Patient Safety, Recruitment & Compliance

Chapter 7: Regulatory Compliance & Ethics

Chapter 8: Adverse Events, Monitoring & Quality

Chapter 9: Advanced Data & Document Management

Chapter 10: Specialized Clinical Trial Therapeutic Areas

Chapter 11 – Week 4: International Clinical Trial Mastery

Chapter 12 – Medical Device Clinical Research

Chapter 13 – Week 4: Technology & Innovation in Research Leadership

Final Review & Certification Assessment

Student Ratings & Reviews

No Review Yet

by Alisha Moore

Certified Principal Investigator (CPI) Certification Prep Course

Description

Course Curriculum

Program Overview

Student Learning Objectives

Certified PI Program Overview

CSRS Program Policies & Enrollment

CSRS Acknowledgment and Agreement

Program Structure, Career Advancement, Orientation, & Learner Support

Chapter 1: Principal Investigator Foundations & Oversight

Module 1: Principal Investigator Roles, Responsibilities, and Oversight Models

Module 1 Quiz: Principal Investigator Roles, Responsibilities, and Oversight Models

Module 2: Why CRIO Matters

Module 2A: CRIO OVERVIEW OF SANDBOX

Module 3A: eSource (Electronic Source Documentation)

Module 4: Investigator Checklists + ICH GCP Alignment Guidelines

Module 3B: Integrated Clinical Trial Management Systems (CTMS, eReg, Financials & Recruitment)

Module 5: FDA Form 1572: Purpose, Commitments, and Investigator Accountability

Module 6: Evolution of the PI Role in Modern Clinical Trials

Module 7: Application of ICH-GCP Principles in Complex Trials

Module 8: Investigator Oversight in Multidisciplinary Research Environments

Module 9: Investigator-Initiated vs Sponsor-Initiated Trials

Module 10: Legal and Ethical Accountability Under U.S. Federal Regulations (21 CFR Overview)

Module 11: IRB and Ethics Committee Processes (Domestic and International)

Module 12: Oversight of Investigational Product Storage, Accountability, and Dispensing

Module 13: Multicenter and Multinational Trial Leadership

Module 14: Financial Disclosure Responsibilities (21 CFR Part 54)

Chapter 2: Advanced Clinical Trial Design & Protocol Development

Module 1: Advanced Review of Trial Phases (Preclinical through Phase 4)

Module 2: Contemporary and Adaptive Trial Designs

Module 3: Advanced Protocol Development and Review

Module 4: IRB / Ethics Committee Requirements and Review Pathways

Module 5: Randomized Controlled Trial Design Principles

Module 6: Inclusion and Exclusion Criteria Development Across Populations

Module 7: Translational Research Protocol Design (Early-Phase Focus)

Module 8: Rare Disease and Orphan Drug Protocol Development

Module 9: Pediatric and Vulnerable Population Trial Design

Module 10: Medical Device Trial Design Considerations

Chapter 3: Documentation, Consent & Regulatory Records

Module 1: Informed Consent Process (ICH-GCP 4.8 – Educational Overview)

Module 2: Trial Management, Documentation, and Recordkeeping

Module 3: Electronic Records and Signatures (21 CFR Part 11 Overview)

Module 4: Essential Regulatory Documentation and Binder Organization

Module 5: Case Report Form Design Principles

Module 6: Investigator’s Brochure Review

Module 7: Trial Master File (TMF) and Industry Models

Module 8: Financial Disclosure and Conflict of Interest Management

Module 9: CRIO Training: eConsent & Regulatory Document Management

Chapter 4: Investigator Leadership & Team Management

Module 1: Leading Multidisciplinary and Multinational Research Teams

Module 2: Delegation of Authority and Team Accountability

Module 3: International Site Selection Strategies

Module 4: Training Global Research Teams for Protocol Compliance

Module 5: CAPA Management for Cross-Border Non-Compliance

Module 6: Sponsor–PI Communication Models

Chapter 5: Monitoring, Site Visits & Audits

Module 1: Types of Monitoring Visits

Module 2: Site and Investigator Selection Processes

Module 3: Site Qualification Visits (SSV/SQV)

Module 4: Site Initiation Visits (SIV)

Module 5: Routine and Remote Monitoring Visits

Module 6: Site Close-Out Visits

Module 7- CRIO Training: Monitoring Reports, Site Payments, & Audit Preparation

Chapter 6: Patient Safety, Recruitment & Compliance

Module 1: History and Principles of ICH-GCP

Module 2: Patient Recruitment and Retention Strategies

Module 3: Patient Engagement and Adherence

Module 4: Protection of Human Subjects

Module 5: Ethical Considerations for Vulnerable Populations

Chapter 7: Regulatory Compliance & Ethics

Module 1: AE and SAE Reporting Responsibilities

Module 2: IND, CTA, and IDE Submissions (Practical Overview)

Module 3: Global Regulatory Compliance Challenges

Module 4: Privacy and Data Protection Laws (HIPAA & GDPR Overview)

Module 5: Expanded Access and Compassionate Use Ethics

Module 6: DSMB Roles and Oversight

Module 7: Preventing Scientific Misconduct

Chapter 8: Adverse Events, Monitoring & Quality

Module 1: Advanced Adverse Event Review

Module 2: Risk-Based Monitoring Strategies