Achieve Excellence As A Research Principal Investigator

Earn $39k-$259k more with advanced PI certification. Master efficient trials, patient outcomes, compliance, and secure more site selections. 100% Money-back Guarantee with 14 Day Refund Policy. Payment Plans Available.

Principal Investigator Training

Advanced Principal Investigator Physician Certification (ARPIC) Syllabus

    1. Introduction to the Advanced Principal Investigator Certification (ARPIC)

      FREE PREVIEW

    2. How to Use PI Course / CME Handout

    3. Live Review Webinar - See discussion for next meeting date

    1. Principal Investigator Toolkit

    2. Principal Investigators Roles, Checklists, & GCP Guidelines

    3. Principal Investigators Reporting Responsibilities for AEs and SAEs

    4. FDA Form 1572

    5. Evolution of the Principal Investigator Role in Modern Clinical Trials

    6. Ethical Standards in Human Research

    7. Understanding and Applying Good Clinical Practice (ICH-GCP) Principles

    8. Role of Principal Investigators in Ensuring Oversight and Compliance in Trials

    9. Investigator-Initiated Trials (IITs) vs. Sponsor-Initiated Trials (SITs)

    10. 21 CFR Regulations - Legal and Ethical Accountability in Complex Clinical Trial Setups

    11. Coordination of Multidisciplinary Collaboration for Comprehensive Trial Oversight

    12. Crafting Sponsorship Agreements and Negotiating Key Investigator Obligations

    13. Institutional Review Board (IRB) and Ethics Committee Processes – Global Variations

    14. Ethical Frameworks for High-Risk and Complex Clinical Research Studies

    15. Investigator Responsibilities for Multinational and Multicenter Clinical Trials

    16. Investigational product (IP) accountability, storage, and dispensing

    17. Investigator-Initiated Multi-Center Trials

    1. Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

    2. Advanced Designs of Clinical Trials

    3. Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

    4. Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

    5. The Clinical Trial Protocol - Advanced Mastery Review

    6. Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

    7. Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

    8. Design of Translational Research Protocols for Early-Phase Studies

    9. Adaptive and Decentralized Trial Designs for Modern Research Needs

    10. Protocol Development for Rare Diseases, Orphan Drugs, and Small Patient Populations

    11. Pediatric Clinical Trials – Ethical and Design Considerations

    12. Designing Clinical Research Studies for Vulnerable Patient Populations

    13. Best Practices for International Multisite Clinical Trials

    14. Behavioral and Psychiatric Research Study Designs

    15. Robust Protocol Management for First-in-Human (FIH) Trials

    16. Medical Device Clinical Trials – Unique Design and Regulatory Factors

    1. Building and Leading Multidisciplinary Research Teams Across Borders

    2. Delegation of Responsibilities to Sub-Investigators and Support Teams

    3. Site Selection Strategies for Diverse International Trials

    4. Training International Research Teams for Protocol Compliance

    5. Coordinating Corrective and Preventive Action Plans (CAPA) for International Non-Compliance

    6. Leadership Strategies for Multi-Site, Cross-Cultural Clinical Trials

    7. Sponsor-PI Communication for Efficient International Collaboration

    1. Informed Consent (ICH GCP Section 4.8)

    2. Trial Management, Data Handling, and Record Keeping

    3. Compliance with E-Signatures CFR 21 Part 11

    4. Essential Regulatory Documents Guidance and Binder Tabs

    5. Guidelines for Designing and Completing Case Report Forms

    6. Do’s and Don’ts of a Case Report Form Design

    7. Investigators Brochures

    8. Trial Master File and DIA Model

    9. Trial Master File Reference Guide

    10. Financial Disclosures and Conflicts of Interest

    1. Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

    2. Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

    3. Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

    4. Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

    5. Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

    6. Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

About this course

  • $499.00
  • 171 lessons
  • Lead Clinical Trials. 17.5 CME.
  • MD/PhD, PI, or Sub-Is can enroll.
  • Salary range $112k-269k+.

Why Choose Our PI Training?

  • PI Graduate Success

    Certified PIs report salary gains of $39k-$259k and higher. Our graduates have achieved roles such as Senior PI, Chief Medical Officer, and Academic Research Leader.

  • Industry Recognition

    Accredited by ACCRE and AMA with 17.5 CME credits recognized worldwide. Prepare for leadership with 163 hours of immersive, online learning. Graduates now lead research at CROs, hospitals, and universities across the globe.

  • Advanced Training For All Levels

    Active MD. PharmDs, PhDs, or non-active MDs can enroll. Fully online and flexible finish in 1-4 weeks. Score 70% or higher on the final exam with 2 attempts (study guide provided). 164 advanced modules, from foundational PI foundations to niche trials.

Principal Investigator Certification

5 star rating

APIPC Course

ROGER ANDERSEN

Course is excellent for covering the key areas that a PI needs to be familiar with.

Course is excellent for covering the key areas that a PI needs to be familiar with.

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5 star rating

Introduction

Eneida Roldan

The introduction and steps to prepare for the modules, achieving success, and certification were very well developed. Excellent introduction.

The introduction and steps to prepare for the modules, achieving success, and certification were very well developed. Excellent introduction.

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5 star rating

Very good Lt

Dr. Bill Akpinar

Good

Good

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Why Physicians Prefer Our PI Training

Physician-developed cutting-edge curriculum with CME and proven trial success.

  • Comprehensive Expertise and Compliance Training

    Master 171 advanced lessons and interactive modules with 17.5 CME credits, covering clinical trial compliance, specialized research, and the latest advancements from the 2025 curriculum.

  • Leadership Development with Practical Application

    Enhance your leadership skills and apply them through real-world scenarios to improve trial outcomes, optimize efficiency, and attract sponsor selections.

  • Flexible Learning and Career Growth

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Join the Next Generation of Principal Investigators

Enroll today to become a leading PI and learn expert-level skills with advanced and recognized training.

Cutting-Edge Curriculum for Principal Investigators

Join our 164-module live/online program, crafted by top physicians and experts, to master clinical trial leadership, streamline protocol management, and drive innovation in research.

  • Principal Investigator Toolkit, Foundations, Clinical Trial Design, and Protocol Development

  • Investigator and Team Leadership, Documents & Informed Consent, Site Visits and Audits

  • Patient Safety, Recruitment, and Compliance, Regulatory Compliance and Ethical Frameworks, Adverse Events, Monitoring, and Quality Assurance

  • Advanced Data and Document Management, Comprehensive Clinical Trial Niches for PIs, International Clinical Trial Mastery

  • Medical Device Clinical Research, Technologies and Innovations in Research Leadership, Final Review & APIPC Certification Exam

Take Charge of Your Clinical Research Career

Attract sponsors. Build better trials. Lead groundbreaking research. With APIPC, your career possibilities expand as you graduate ready to take on meaningful roles that impact patient outcomes and innovation across the globe.