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(a) The applicant (of an application submitted under sections 505, 506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical studies shall submit, for each clinical investigator who participated in a covered clinical study, either a certification described in paragraph (a)(1) of this section or a disclosure statement described in paragraph (a)(3) of this section.

(1) Certification: The applicant covered by this section shall submit for all clinical investigators (as defined in § 54.2(d)), to whom the certification applies, a completed Form FDA 3454 attesting to the absence of financial interests and arrangements described in paragraph (a)(3) of this section. The form shall be dated and signed by the chief financial officer or other responsible corporate official or representative.

(2) If the certification covers less than all covered clinical data in the application, the applicant shall include in the certification a list of the studies covered by this certification.

(3) Disclosure Statement: For any clinical investigator defined in § 54.2(d) for whom the applicant does not submit the certification described in paragraph (a)(1) of this section, the applicant shall submit a completed Form FDA 3455 disclosing completely and accurately the following:

(i) Any financial arrangement entered into between the sponsor of the covered study and the clinical investigator involved in the conduct of a covered clinical trial, whereby the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study;

(ii) Any significant payments of other sorts 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;

(iii) Any proprietary interest in the tested product held by any clinical investigator involved in a study;

(iv) Any significant equity interest in the sponsor of the covered study held by any clinical investigator involved in any clinical study; and

(v) Any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments.

Financial disclosure rules

Contains 36 Rules

Confirm these elsewhere

Contains 36 Rules

21 CFR 54.2(a)From 21 CFR 54.2 — Definitions

21 CFR 54.2(b)From 21 CFR 54.2 — Definitions

21 CFR 54.2(c)From 21 CFR 54.2 — Definitions

21 CFR 54.2(d)From 21 CFR 54.2 — Definitions

21 CFR 54.2(e)From 21 CFR 54.2 — Definitions

21 CFR 54.2(f)From 21 CFR 54.2 — Definitions

21 CFR 54.2(g)From 21 CFR 54.2 — Definitions

21 CFR 54.2(h)From 21 CFR 54.2 — Definitions

21 CFR 54.4(a)From 21 CFR 54.4 — Certification and disclosure requirements

21 CFR 54.4(b)From 21 CFR 54.4 — Certification and disclosure requirements

21 CFR 54.4(c)From 21 CFR 54.4 — Certification and disclosure requirements

21 CFR 54.5(a)From 21 CFR 54.5 — Agency evaluation of financial interests

21 CFR 54.5(b)From 21 CFR 54.5 — Agency evaluation of financial interests

21 CFR 54.5(c)From 21 CFR 54.5 — Agency evaluation of financial interests

21 CFR 54.6(a)From 21 CFR 54.6 — Recordkeeping and record retention

21 CFR 54.6(b)From 21 CFR 54.6 — Recordkeeping and record retention

Certify and explain when information is unobtainableFrom Financial Disclosure by Clinical Investigators

Provide appropriate certifications disclosures and explanationsFrom Financial Disclosure by Clinical Investigators

Make a complete and accurate disclosureFrom Financial Disclosure by Clinical Investigators

Provide sufficient accurate financial information to sponsorsFrom Financial Disclosure by Clinical Investigators

Confirm these elsewhere

Contact the FDA staff responsible for implementing this guidanceFrom Financial Disclosure by Clinical Investigators

Call the appropriate number listed on the title page of this guidanceFrom Financial Disclosure by Clinical Investigators

Consult with FDA as to which clinical studies constitute covered clinical studiesFrom Financial Disclosure by Clinical Investigators

Make appropriate efforts to obtain information by other meansFrom Financial Disclosure by Clinical Investigators

Try to locate the clinical investigatorFrom Financial Disclosure by Clinical Investigators

Exercise reasonable judgment regarding the appropriate amount of effort to expendFrom Financial Disclosure by Clinical Investigators

Maintain copies of delivery and undeliverable noticesFrom Financial Disclosure by Clinical Investigators

Exercise due diligence whether a covered study is conducted at foreign or domestic sitesFrom Financial Disclosure by Clinical Investigators

Collect and maintain required financial information at the first opportunityFrom Financial Disclosure by Clinical Investigators

Consult with FDA prior to and during clinical studies about management of potential biasFrom Financial Disclosure by Clinical Investigators

Request sufficient detail about financial disclosure informationFrom Financial Disclosure by Clinical Investigators

Report an equity interest when the holding exceeds the thresholdFrom Financial Disclosure by Clinical Investigators

Retain complete recordsFrom Financial Disclosure by Clinical Investigators

Take steps to ensure clinical investigator complianceFrom Financial Disclosure by Clinical Investigators

Provide updated financial information promptlyFrom Financial Disclosure by Clinical Investigators

Retain required information on financial interests and arrangementsFrom Financial Disclosure by Clinical Investigators