The Investigator’s Guide to Form FDA 1572: Getting the Statement of Investigator Right
Investigators: fail to comply with Form FDA 1572 and you face serious consequences.
You definitely don’t want to receive an FDA citation of “failure to follow the investigational plan.” That’s why you need The Investigator’s Guide to Form FDA 1572: Getting the Statement of Investigator Right.
Deviate even a little from your Form FDA 1572—Statement of Investigator and you’ll become a statistic: this is by far the most serious, and most common, citation following an FDA inspection.
The 1572 is more than mere paperwork. It’s a binding legal contract between the principal investigator (PI), the trial’s sponsor and the FDA to conduct a clinical trial. Meaning that if you fail to follow it, it can lead to serious consequences.
Despite instructions and a specific guidance on the form, the FDA’s Good Clinical Practice Program (GCPP) fields a multitude of questions each year from investigators uncertain of how to fill out a 1572. Understandably, these PIs are reluctant to risk noncompliance when the consequences can be severe — from having their trials suspended to being disqualified from future research.
Instead, feel confident when you agree to take on a trial and ensure you stay compliant with The Investigator’s Guide to Form FDA 1572.
You’ll get all the resources you need to accurately complete a 1572, including an explanation of the form’s purpose, consequences of noncompliance and a detailed breakdown of each section and what it requires.
Management Report Takeaways:
- The many ways a PI can deviate from the 1572 and real-life examples of PIs who did
- FDA 2021 inspection metrics for PIs
- How and by whom 1572s should be signed and stored
- What personnel and facilities must be listed on the form
- How Form 1572 relates to investigators’ financial disclosure statements
- Official answers to questions other PIs asked the FDA
- The consequences of investigator disqualification
Bonus! This guide includes a copy of the Form FDA 1572, the guidance Frequently Asked Questions—Statement of Investigator and other important guidances.
Success with Form 1572 starts with The Investigator’s Guide to Form FDA 1572: Getting the Statement of Investigator Right. You can’t afford to sign one without it.
Who Will Benefit
- Principal investigators
- Clinical research coordinators
- Clinical research associates
- Site managers
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