Regulatory Module
Embarking into the World of Clinical Research
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.
Core Values
Is your organization ready?
What you'll need
Filling Your Staffing Roles
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
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
Get started with the Regulatory Module now!