Principal Investigator Training

PI Certification

Industry-Recognized PI Training. We equip licensed physicians in their country with the knowledge and skills to undertake the role of Principal Investigator in clinical research. Accredited by AMA for 17.5 CME and trusted by over 391 physicians and used for PI training. Salary range 42k-112k+ not including base physician salary. Complete in 1-3 weeks with flexibility on module completion. See why clinical research organizations trust us to train their physicians.
Principal Investigator Training

Demo PI Certification

Principal Investigator Training

Principal Investigator Training

Advanced Principal Investigator Physician Certification (APIPC) Syllabus

    1. CME Handout

    2. Principal Investigator Toolkit

    3. How to Effectively Use this Course

    1. Principal Investigators Roles, Checklists, & GCP Guidelines

    2. Principal Investigators Reporting Responsibilities for AEs and SAEs

      FREE PREVIEW

    3. FDA Form 1572 - Part 1

    4. FDA Form 1572 - Part 2

    5. Investigator Initiated Multi-Center Trials

    6. Investigational Product Storage and Dispensing

    7. Investigational Product Accountability in Clinical 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)

    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. Advanced Review of Adverse Events

    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

  • $300.00
  • 47 lessons
  • 12.5 hours of video content

CCRPS Reviews

Principal Investigator Certification

5 star rating

Appropriately named

Dr. Gilbert Teixeira

I would characterize some of the lectures as monotonous. While providing a plethora of information, instructors ought to possess an enhanced comprehension of...

Read More

I would characterize some of the lectures as monotonous. While providing a plethora of information, instructors ought to possess an enhanced comprehension of the subject matter. This would enable them to effectively distill the essential concepts required for learning, rather than merely presenting an assortment of factual statements. By doing so, students would be able to comprehend the significance of the material, thereby enhancing their overall understanding of the topic.

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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.

Read Less
5 star rating

Very good Lt

Dr. Bill Akpinar

Good

Good

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Online Principal Investigator Training Program

CCRPS offers online principal investigator training to physicians interested in beginning a career as a PI or advancing their trial efficiency & outcomes. The principal investigator training course is designed for physicians seeking advanced review and understanding to assist in obtaining the knowledge needed for initial PI roles.
Online principal investigator training program

Principal Investigator Certification

Principal Investigator Roles And Responsibilities In Clinical Research

PI principal investigator is responsible for the preparation, conduct, and completion of the research or project being funded by a grant or sponsor. This is increased by having additional educational training such as through CCRPS’s Advanced Principal Investigator Physician Certification (APIPC)™. Principal Investigator Salary ranges between $37k to $279k as additional salary.
Role of Principal Investigator in Clinical Research

Advanced Principal Investigator Certification

  • Accredited

    CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited with PIMED by the American Medical Association (AMA) to provide 17.5 CME credits for physicians. ICH GCP and E6 certification (required Q3 years) is provided and recognized through meeting Transcelerate BioPharma requirements.

  • Improve selection, efficiency, & outcomes

    While certification is not required for PIs to conduct trials, PI-sponsors and organization sponsors can show sponsors that PIs receive therapeutic-specific education and content-backed certification. Most broadly, training can be another quality initiative to prevent trial errors. Because PI certification through examination requires at least 3k hours of experience, physicians in our online principal investigator training program seek this course to assist in their positions as a PI.

  • Physician-created

    We teach in-depth with modules covering things like developing inclusion-exclusion criteria, writing protocols, etc. Our focus is on including multiple practical references, applications, and perspectives such that PIs can feel more comfortable making critical decisions in the trial. With CCRPS training physicians and PIs can function as a certified principal investigator.

Succeed as a Principal Investigator

  • Protect subject safety: Protect subjects from harm, Keep track of drugs and distribute only as specified in the protocol, Obtain informed consent, Ensure IRB approval, Keep careful records and maintain them for as long as the protocol dictates or at least 2 years AND

  • Report: Progress, safety, financial, and a final report to the study sponsor, Adverse events; serious adverse events must be reported immediately, Update financial disclosures if any circumstances change during the study AND

  • Follow Form 1572: Strictly adhere to the protocol, Directly supervise the study and take responsibility for study staff, Inform subjects of experimental nature of the drug products, Report adverse events and stay updated on the investigational brochure, Maintain records, Ensure IRB compliance AND

  • Prepare for FDA inspections: Ensure all records are complete and easily accessible by FDA, Send a written response within 15 business days if any violations are found AND

  • Avoid violations: Read all communications from the IRB, Hire experienced staff and verify their credentials, Train staff regularly, Check for conflicts of interest/financial disclosures regularly, Write efficient protocols or reduce inefficiencies or confusing portions of the protocol, Keep regulatory binders up to date and conduct continuing reviews, Meet with the team regularly, Conduct several dry runs to ensure the study will run smoothly, Regularly check data processes