<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
hero-bg.png

CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH COORDINATOR: Principal Investigator Training

COURSE DESCRIPTION:

Attendees will be able to describe the responsibilities of a principal investigator, understand the requirements they must follow when conducting a clinical study, understand how responsibilities may be delegated to other study personnel with proper oversight, and recall common warning letter findings. The PI Package includes our signature FAIR Shake(TM) technique, which teaches the learner to take an otherwise complicated maze of requirements and break them down into four simple areas that can be applied to solving clinical research questions. Attendees will understand how to protect research subjects and how and when to report adverse events.

LEARNING OBJECTIVES:

  • Review FDA regulations and ICH GCP E6 Guideline for Good Clinical Practice (GCP)

  • Describe Investigator responsibilities in the context of study protocol oversight and GCP compliance

  • Recognize critical elements of human subject protection

  • Discuss the requirements for investigational product management and maintenance of adequate and accurate records

  • Recognize key requirements for patient safety management and regulatory reporting

  • Examine recent trends in non-compliance and BIMO Inspections

COURSE OUTLINE

AGENDA 8:00 am - 5:00 pm

  • Introduction to Good Clinical Practice: ICH GCP Guidelines

  • Introduction to the U.S. FDA Regulations for Clinical Research

    • 21 CFR Parts 312, 812, 50, 56, 54, and 11

    • INDs vs IDEs: Comparing 21 CFR Parts 312 and 812

  • Human Subject Protection

    • Drilling Down 21 CFR Part 50:Conducting and Documenting Proper Informed Consent

    • Protecting Subject Protected Health Information (PHI): HIPAA and HITECH

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Key Roles and Responsibilities in Clinical Research Overview

    • Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager, and Statistician

  • High Quality Documentation and Study Records

    • Source Documentation

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

  • Hosting Sponsor Monitors and Auditors

  • Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites

  • Day In The Life of an Effective Principal Investigator: Best Practices

 

TYPE

In Person Training - At IMARC or Your Location

CONTINUING EDUCATION CONTACT HOURS (CEUs)
8.0 hours (0.8 CEUs)

KNOWLEDGE LEVELS:

  • Beginner
  • Intermediate

WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion 

ADDITIONAL WEB-BASED COURSE ADD-ONS

  • History of Clinical Research

  • Critical Thinking in Clinical Research

  • Monitoring Overview

  • Maintaining the Sponsor TMF

  • Introduction to Risk-Based Monitoring

  • FDA Inspectional Findings

 

Training Solutions For These Roles

New or current investigators who need training on their research responsibilities

training.png

REGISTER FOR ONLINE TRAINING SERVICES