I’m sure most of us can agree, regulatory is the most tedious and quite yawn worthy topic in our industry. A lot of clinical research professionals from clinical coordinator, regulatory specialist to the site manager have head scratching moments concerning regulatory while conducting human trials. Our goal is to ease your pain and provide influential support in this process.

Course Curriculum

  • 1

    Core Values of Conducting Clinical Trials

    • Core Values

    • Is your organization ready?

    • What you'll need

    • Filling Your Staffing Roles
  • 2

    Submitting to the Institutional Review Board

    • Understanding what an Institutional Review Board (IRB) is

    • Process of Site IRB Submission/Approval

    • Initial IRB Submission

    • Submission Source Video

    • Rules for Submitting Recruitment Materials

    • Other Forms to Submit

    • FDA 1572 Form

    • FDA 1572 Form Demo

    • Helpful Tips for Beginners (and experts)

    • Financial Disclosure Forms

    • Types of Financial Interest

    • Protocol Signature Page

    • Protocol Signature Demo

    • Investigational Brochure

    • Investigational Brochure Signature Page

    • Deviations or Protocol Violations

    • Deviation/Violation Collection

    • Reporting Violations

    • SAE Reporting

  • 3

    Regulatory Binder

    • Maintaining Regulatory Files

    • Binder Tabs

    • Delegation of Authority Log

    • Sample Site Signature Log Delegation of Responsibilities

    • Tips & Tricks

    • Subject Enrollment Log

    • Confidential Subject List

    • Investigational Product Accountability Log

    • Sample

    • Investigational Product Accountability Log

    • Laboratory CLIA

    • Obtaining a CLIA or CLIA Waiver

    • Sample Certificate of Waiver

    • IRB Continuing Review

    • Site Annual Review

    • Closure Report

    • Course Review

    • Closure Report

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