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IMPAACT Clinical Investigators Disclosure of Financial Interests and Arrangements for US FDA Please complete all of the information below, including providing your signature where indicated. 1. Protocol.

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Certification: Financial Interests and Arrangements of Clinical Investigators. Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators.

4.1 Each clinical investigator /sub-Investigator must submit either a completed financial disclosure statement attesting to the absence of financial interests/arrangement or disclose any financial interests/arrangements and steps taken to minimize the potential for bias.

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 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.”

applicants may submit a single FORM FDA 3455, with attachments clearly identifying all clinical investigators with information to disclose and, for each investigator, identifying the study, the specific details of their financial interests and arrangements and the steps taken to minimize the potential for bias.

Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions.

Financial disclosure reports are used to identify potential or actual conflicts of interest. If the person charged with reviewing an employee's report finds a conflict, he should impose a remedy immediately. The employee's supervisor, with his ethics official, should decide on the remedy.

Certification: Financial Interests and Arrangements of Clinical Investigators. Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators.

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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