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.
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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.
- Press the ‘Get Form’ button to access the form and open it in the online editing platform.
- 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.
- 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.
- 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.
- Provide detailed information about the individual’s disclosable financial arrangements and interests in the section provided. Attach additional documentation if necessary.
- Complete the title, name, and firm/organization fields to identify yourself as the applicant submitting the form.
- Sign and date the form using the specified date format (mm/dd/yyyy) to certify the disclosures made in this document.
- 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.
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What is the difference between FDA Form 3454 and 3455?
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.
Who needs to complete a financial disclosure form in clinical trials?
§ 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.
What is FDA 3455?
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.
What is the purpose of FDA Form 3455?
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.
What is the purpose of the 3454 form?
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.”
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