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The Investigator’s Guide to Form FDA 1572 Management Report

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FALLS CHURCH, Va. (PRWEB)

The Investigator’s Guide to Form FDA 1572:

Getting the Statement of Investigator Right

https://www.centerwatch.com/products/568

If investigators fail to comply with Form FDA 1572, they face serious consequences.

Deviate even a little from the FDA 1572, Statement of Investigator and become a statistic: this is by far the most serious, and most common, citation following an FDA inspection.

The 1572 is more than mere protocol. 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 the investigator fails to comply it can lead to serious consequences.

Instead, readers can feel confident when agreeing to take on a trial, stay compliant and avoid having trials suspended or being disqualified from future research with The Investigator’s Guide to Form FDA 1572 management report.

Readers will get all the resources a PI needs 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:


  • Bioresearch Monitoring Program (BIMO) inspection metrics

  • The process for submitting a 1572 to the sponsor and IRB

  • How investigator agreements differ in medical device trials

  • How to respond to a 483 citation of failure to follow the investigational plan

  • 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 disclosures and conflict-of-interest statements

This guide includes a copy of the Form FDA 1572 and the guidance Frequently Asked Questions, Statement of Investigator, which provides information on BIMO’s inspections of investigators, samples of 483s citing and explaining a PI’s failure to follow the investigational plan, and answers from the FDA’s Good Clinical Practice Program (GCPP) to investigators’ specific questions.

Success with Form 1572 starts with The Investigator’s Guide to Form FDA 1572: Getting the Statement of Investigator Right. PI’s can’t afford to sign one without it.

Management Report Details:

The Investigator’s Guide to Form FDA 1572:

Getting the Statement of Investigator Right

https://www.centerwatch.com/products/568

Price:

$247

Easy Ways to Order:

Online: https://www.centerwatch.com/products/568

By phone: 888.838.5578 or 703.538.7600

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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