Advanced Principal Investigator Physician Certification (APIPC)™

Principal Investigator Training

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.

Because PI certification through examination (not required to conduct trials, but an asset to getting more sponsors/funding) requires at least 3,000 hours of experience as a principal investigator, physicians in our online principal investigator training program seek this course to assist in their positions as a PI.

 

PI Course Syllabus

Introduction

  • Accreditation Statement

  • CME Handout - How to Obtain 17.5 CME Credits through AMA/ACCME

  • Principal Investigator Toolkit

  • How to Effectively Use this Course

  • The Role of the Principal Investigator

    • Principal Investigators Roles, Checklists, & GCP Guidelines

    • Principal Investigators Reporting Responsibilities for AEs and SAEs

    • FDA Form 1572 - Part 1

    • FDA Form 1572 - Part 2

    • Investigator Initiated Multi-Center Trials

    • Investigational Product Storage and Dispensing

    • Investigational Product Accountability in Clinical Trials

  • Clinical Trial Design & Protocol

    • Phases of Clinical Trials

    • Designs of Clinical Trials

    • Randomized Controlled Trials

    • Institutional Review Board (IRB)

    • The Clinical Trial Protocol - Advanced Mastery Review

    • Protocol Deviations and Violations

    • Inclusion and Exclusion Criteria in Clinical Research

    • IND Application

    • IND and NDA Process

  • Documents & Informed Consent

    • Source Documents and Informed Consent Forms

    • Informed Consent (ICH GCP Section 4.8)

    • Trial Management, Data Handling, and Record Keeping

    • Compliance with E-Signatures CFR 21 Part 11

    • Essential Regulatory Documents Guidance and Binder Tabs (Part 1)

    • Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

    • Guidelines for Designing and Completing Case Report Forms

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

    • Investigators Brochures

    • Trial Master File and DIA Model

    • Trial Master File Reference Guide

    • Financial Disclosure- Duties and Strategies for Clinical Studies

    • Financial Disclosures and Conflicts of Interest in Clinical Research

  • Adverse Events

    • Advanced Review of Adverse Events

    • Reporting of Adverse Events

    • Safety Reporting Requirements for Sponsor Investigators of An IND

  • Site Visits and Audits

    • Overview of Types of Monitoring Visits

    • Site and Investigator Selection

    • Site Selection/Qualification Visit (Pre-Study Visit)

    • Site Close Out Visit

    • Audits vs. Inspections

    • FDA Warning Letter

    • Site FDA Audit Inspection Checklist

    • How to Survive Through an FDA Inspection

    • Do and Don’ts during an FDA Inspection

  • Patient Safety, Recruitment, and Compliance

    • Introduction & History of ICH GCP

    • Compliance Requirements in Clinical Trials

    • Subject Recruitment and Retention (Part 1)

    • Subject Recruitment and Retention (Part 2)

    • Safety of Human Subjects in Clinical Research

    • Ethics of Research Involving Pregnant Women and Fetuses

    • Ethics of Research Involving Mentally Incapacitated

    • Ethics of Research Involving Children

    • Scientific Misconduct in Research and How to Prevent It

    • Increasing Subject Compliance in Clinical Trials

    • Misconduct in Research – Detecting Falsification

  • Self-Assessments

    • Self-Assessment MiniQuiz 1

    • Self-Assessment MiniQuiz 2

    • Self-Assessment Quiz A

    • Self-Assessment Quiz B

    • Final Quiz

How do I study for the course?

This course is extensive but that does not mean you need to review it like we may have for First Aid during Step 1. The course contains multiple checklists and references to help you get multiple angles of learning in order to understand the big picture of making the trials you run more efficient and successful.

At the end of the course, you should no memorize everything. Instead, run through this course and stop at checklists to see how they could be applied to your prior/future trials. Discussions are enabled so you can have a "social" way of jotting down notes to keep you engaged.

Online learning is tough, but this course should give you the references, checklists, and broad overview you may need to improve your trial (not remotely memorize protocols and document names). i.e. Look at images and diagrams to see what aspects pertain to you. Mark modules or screenshot checklists that you may want to use with your study coordinator.

In order to finish the course, you should skim each module and stop are parts that pertain to issues you may have with running the trial. Then take the mandatory final quiz to get certified. You can then get your 17.5 CME credits as well.


What does a PI need to run a trial?

-Examination rooms for conducting physicals and discussions with study subjects.

-Office equipment such as a computer with high speed internet access, fax machine, and telephone for patient scheduling and study correspondence.

-Phlebotomy and laboratory shipping materials storage area.

-A locked storage area for study materials and study medication.

-A locking calibrated refrigerator and freezer for lab samples (and potentially for study medication).

-Adequate working space for on-site visits from sponsor representatives or regulatory authorities.

-A secure storage area for archiving study records per regulatory requirements.


When should I take the ACRP PI Certification Exam?

CCRPS is not affiliated with ACRP but our PI course over the same industry-accepted topics as the ACRP PI certification exam to serve as an optional review course while gaining 17.5 CME credits. While the ACRP PI exam is not required, outside of this course/certification it can be another asset in getting more sponsors/funding once you have 3,000 hours of experience. Before you start the course, you should review the ACRP PI Exam Outline so you can use it to a) study the key concepts agreed upon by the industry during this course and also b) simultaneously prepared to sit for the ACRP PI exam.

How long is the course?

The course is fully self paced and be completed in as little as 2 week or over the course of a few months to cover all of the material. We like to provide comprehensive training materials so PIs can reference them at a later point but certification only requires the completion of self assessments, thus, certification can be completed as quickly as the assessments and self-review.

Is the certification accredited?

Yes! 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.

Certified Principal Investigator Training

The PI training program is developed for each specific PI who inquires for us based on their therapeutic field. Physicians receive 17.5 CME credits and are accredited by the ACCRE and AMA/Joint Commission. We are also in review to provide post-graduate credit through the Department of Education. ACCRE is the primary accrediting body of clinical research education courses The benefits of the PI training course is to improving efficiency, learning about multiple similar trials, and getting the fund of knowledge needed to improve quality, teamwork, and data. 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. Also, MDs can cover their annual CME requirements through the same course. Most broadly, training can be another quality initiative to prevent trial errors. 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.  The course is written by physicians and is self-paced (2-10 week completion). We customize for SOPs, trial-specific MOPs, similar trials, and therapy-related medical knowledge reviews; this takes 7-14 days. The course can be hosted on a company subdomain. We most recently did this for a mid-size CRO conducting multisite trials in South America.