We use cookies to improve security, personalize the user experience, enhance our marketing activities (including cooperating with our marketing partners) and for other business use.
Click "here" to read our Cookie Policy. By clicking "Accept" you agree to the use of cookies. Read less
Read more
Accept
Loading
Form preview
  • US Legal Forms
  • Form Library
  • More Forms
  • More Multi-State Forms
  • Hhs Form Fda 3455 2022

Get Hhs Form Fda 3455 2022-2025

Form Approved: OMB No. 09100396 Expiration Date: March 31, 2019DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationDISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS.

How it works

  1. Open form

    Open form follow the instructions

  2. Easily sign form

    Easily sign the form with your finger

  3. Share form

    Send filled & signed form or save

How to fill out the HHS Form FDA 3455 online

Filling out HHS Form FDA 3455, which pertains to the disclosure of financial interests and arrangements of clinical investigators, can seem daunting. This guide provides clear, step-by-step instructions to assist users in completing the form accurately and efficiently.

Follow the steps to complete the form with ease.

  1. Press the ‘Get Form’ button to access the form and open it in the online editing platform.
  2. Identify the first section of the form, which requests the name of the clinical investigator. Enter the full name of the individual who participated in the submitted study.
  3. In the next section, specify the name of the clinical study. Ensure that the name corresponds to the study in which the investigator was involved.
  4. Proceed to mark the applicable checkboxes related to financial arrangements and interests. These include: any financial arrangement that could influence the outcome of the study, significant payments made post-February 2, 1999, proprietary interests, and equity interests in the sponsoring organization.
  5. Provide detailed information about the individual’s disclosable financial arrangements and interests in the section provided. Attach additional documentation if necessary.
  6. Complete the title, name, and firm/organization fields to identify yourself as the applicant submitting the form.
  7. Sign and date the form using the specified date format (mm/dd/yyyy) to certify the disclosures made in this document.
  8. Once all fields are accurately filled, review the information for completeness and correctness. You can then save changes, download the form for personal records, print it, or share it as needed.

Submit your completed HHS Form FDA 3455 online to ensure compliance and transparency in clinical studies.

Get form

Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Get form

Related content

Financial Interest and Arrangements of Clinical...
This section applies only to the requirements of the Paperwork Reduction Act of 1995. An...
Learn more
Financial Disclosure by Clinical Investigators
Feb 8, 2013 — applicants may submit a single FORM FDA 3455, with attachments clearly...
Learn more
ANDA Submissions —Content and Format Guidance...
study and a disclosure statement (FDA Form 3455) for each clinical investigator who, or...
Learn more

Related links form

Dd Form 285 Blank Audiogram Dd Form 565 Dental Screening Form

Questions & Answers

Get answers to your most pressing questions about US Legal Forms API.

Contact support

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.

§ 54.4 Certification and disclosure requirements. The applicant is required to submit for each clinical investigator who participates in a covered study, either a certification that none of the financial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency.

Form FDA 3454. Certification: Financial Interests and Arrangements of Clinical Investigators. Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators. MedWatch Forms: FDA Medical Product Reporting Program.

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 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.”

Get This Form Now!

Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
Get form
If you believe that this page should be taken down, please follow our DMCA take down processhere.

Industry-leading security and compliance

US Legal Forms protects your data by complying with industry-specific security standards.
  • In businnes since 1997
    25+ years providing professional legal documents.
  • Accredited business
    Guarantees that a business meets BBB accreditation standards in the US and Canada.
  • Secured by Braintree
    Validated Level 1 PCI DSS compliant payment gateway that accepts most major credit and debit card brands from across the globe.
Get HHS Form FDA 3455
Get form
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
Help Portal
Legal Resources
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
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
Help Portal
Legal Resources
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