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Tarting Dec. 26, 2007, any application or report submitted to FDA under Sections 505, 510(k) or 520(m) of the FDC Act or under Section 351 of the PHS Act must include a certification of compliance 9 10 11 12 Logistics and Questions Office of Policy 301 827 3360 Submit the form once per protocol If starting out with Phase 1 IND, submit 3674 and check Box 9B. As program progresses in Phase 2 or 3 submit 3674, check Box 9C and e.

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Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff. Contributor(s): United States. Department of Health and Human Services, issuing body.

WHAT IS CLINICAL PROOF OF CONCEPT (POC)? POC clinical studies are an early stage of clinical drug development, when a compound has shown potential for human therapeutic use, after preclinical animal models and early safety testing. This step often links Phase I (first in human) and dose-ranging Phase-II studies.

Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. It is important to remember that the FDA does not conduct Clinical Trials.

To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions.

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”

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.
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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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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