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TLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312) (See instructions on reverse side.) NOTE: No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)). 1. NAME AND ADDRESS OF INVESTIGATOR 2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED. CURR.

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How to use or fill out the Fda Form 1572 Fillable online

Filling out the Fda Form 1572 is a crucial step for investigators looking to participate in clinical trials regulated by the FDA. This guide will provide you with clear and supportive instructions to help you complete the form accurately and efficiently.

Follow the steps to complete the Fda Form 1572 Fillable online.

  1. Click the ‘Get Form’ button to obtain the form and open it in your preferred editable format.
  2. In the first section, provide the name and address of the investigator. Ensure that all information is complete and accurate to avoid processing delays.
  3. Next, in section two, outline your education, training, and experience that establish your qualifications as an expert in the clinical investigation of the drug under study. Attach a curriculum vitae or another relevant statement of qualifications.
  4. For section three, indicate the name and address of any medical school, hospital, or other facility where the clinical investigation will be conducted.
  5. In section four, provide the name and address of any clinical laboratory facilities that will be involved in the study.
  6. Section five requires you to specify the name and address of the Institutional Review Board (IRB) responsible for overseeing and approving the study.
  7. In section six, list the names of any subinvestigators who will assist in the conduct of the investigations.
  8. Next, complete section seven by providing the name and protocol number, if applicable, for each study you will conduct.
  9. For section eight, attach the necessary clinical protocol information as outlined, including details concerning the study's estimated duration and the number of subjects involved.
  10. In section nine, review and agree to the commitments listed. This ensures you understand your obligations regarding the conduct of the study.
  11. Finally, sign and date the form in the designated areas and ensure all attachments are included before submitting it to the sponsor.
  12. You can now save changes, download, print, or share the completed form as needed.

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A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the Form FDA 1572.

For documents created electronically on a file system, signatures may be obtained electronically if a mechanism is available to the signer. For example, an FDA 1572 Statement of Investigator form can be filled out within Adobe and signed using an available digital certificate outside of any document management system.

Explanation: The FDA Form 1572, also known as the "Statement of Investigator," is a document that an investigator must sign before participating in a clinical trial involving investigational drugs.

Field 1: NAME OF AND ADDRESS OF INVESTIGATOR. Field 2: EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN. EXPERT IN THE CLINCIAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. Field 3: NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH.

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232