How to Fill Out Form FDA 3455

Form FDA 3455 at a glance

What it is: Form FDA 3455 is the Food and Drug Administration's Disclosure: Financial Interests and Arrangements of Clinical Investigators.

Who signs: The applicant completes this form.

A filled-in Form FDA 3455 example: an applicant discloses an equity interest

Form FDA 3455 example filled out, example: an applicant discloses an equity interest
An applicant fills out Form FDA 3455 for one clinical investigator. The investigator holds a significant equity interest, so every other applicable check box stays empty. The picture shows page 1; its names and figures are sample values.

How to fill out Form FDA 3455, box by box

Name of clinical investigator and clinical study

Form FDA 3455 example filled out, name of clinical investigator and clinical study

Enter the Name of clinical investigator who participated as a clinical investigator in the submitted study.

Enter the Name of clinical study.

The information is submitted in accordance with 21 CFR part 54: the named individual has participated in financial arrangements or holds financial interests that are required to be disclosed.

Applicable check boxes

Form FDA 3455 example filled out, applicable check boxes

Mark the applicable check boxes.

Mark any financial arrangement entered into between the sponsor of the covered study and the clinical investigator involved in the conduct of the covered study, whereby the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study.

Mark any significant payments of other sorts made on or after February 2, 1999, from the sponsor of the covered study, such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria.

Mark any proprietary interest in the product tested in the covered study held by the clinical investigator.

Mark any significant equity interest, as defined in 21 CFR 54.2(b), held by the clinical investigator in the sponsor of the covered study.

Details of the individual's disclosable financial arrangements and interests are attached, along with a description of steps taken to minimize the potential bias of clinical study results by any of the disclosed arrangements or interests.

Name, title, firm and signature

Form FDA 3455 example filled out, name, title, firm and signature

Enter the NAME, TITLE and FIRM/ORGANIZATION.

Add the SIGNATURE and the Date (mm/dd/yyyy).

Sources

[1] Form FDA 3455 (4/26), Disclosure: Financial Interests and Arrangements of Clinical Investigators, Food and Drug Administration (the Official source link on this page).

Form FDA 3455 PDF Details

Mark the applicable check boxes.

Do not send: do NOT send your completed form to the PRA Staff email address.

OMB number: a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Reporting burden: public reporting burden for this collection of information is estimated to average 5 hours per response.

QuestionAnswer
Form NameForm FDA 3455
Form Length1 page
Fillable?Yes
Fillable fields19
Avg. time to fill out4 min
Edition4/26
Issuing agencyFood and Drug Administration
OMB number0910-0396
Expiration dateJuly 31, 2028
Matches the agency's fileYes, checked October 3, 2026
Other namesFDA 3455, FDA3455, Form FDA 3455, Form 3455, FDA form 3455, 3455 FDA form, FDA financial disclosure form 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators
Official sourceForm FDA 3455 (Rev 4/26), Food and Drug Administration

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