Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff

Description

This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54.  This document is a revision of theGuidance for Industry: Financial Disclosure by Clinical Investigatorsdated March 20, 2001.  In order to address issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services, in its report, OEI-05-07-00730,The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Informationas well as questions FDA has received from industry and the public, FDA issued a revised guidance in draft in May 2011 for public comment.  Comments were received from 13 individuals and entities, which were considered in preparing this final guidance.  FDA encourages applicants and sponsors to contact the agency for advice concerning specific circumstances regarding financial disclosures that may raise concerns as early in the product development process as possible.

Scope & Applicability

Regulatory Context

• 21CFR54.4§ 54.4 Certification and disclosure requirements.

  For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether the applicant's product meets FDA's marketing requirements, identifying those clinical investigators who are full-time or part-time employees of the spRead full regulation →

• 21CFR54.5§ 54.5 Agency evaluation of financial interests.

  (a) Evaluation of disclosure statement. FDA will evaluate the information disclosed under § 54.4(a)(2) about each covered clinical study in an application to determine the impact of any disclosed financial interests on the reliability of the study. FDA may consider both the size and nature of a discRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR314.94§ 314.94 Content and format of an ANDA.

  ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →

• 21CFR812.140§ 812.140 Records.

  (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:Read full regulation →

• 21CFR312.57§ 312.57 Recordkeeping and record retention.

  (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such Read full regulation →

• 21CFR812.43§ 812.43 Selecting investigators and monitors.

  (a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.Read full regulation →

• 21CFR312.53§ 312.53 Selecting investigators and monitors.

  (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.Read full regulation →

• 21CFR54.6§ 54.6 Recordkeeping and record retention.

  (a) Financial records of clinical investigators to be retained. An applicant who has submitted a marketing application containing covered clinical studies shall keep on file certain information pertaining to the financial interests of clinical investigators who conducted studies on which the applicaRead full regulation →

• 21CFR54.1§ 54.1 Purpose.

  (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices.Read full regulation →

• 21CFR54.2§ 54.2 Definitions.

  For the purposes of this part:Read full regulation →

• 21CFR54.3§ 54.3 Scope.

  The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either Read full regulation →

• 21CFR812.20§ 812.20 Application.

  (a) Submission.Read full regulation →

• 21CFR312.3§ 312.3 Definitions and interpretations.

  (a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:Read full regulation →

• 21CFR812.3§ 812.3 Definitions.

  (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →

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