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HHS - 21 CFR PART 54

FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

active, Most Current
Organization: HHS
Publication Date: 1 April 2016
Status: active
Page Count: 5
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 contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant.

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.

(b) The agency reviews data generated in these clinical studies to determine whether the applications are approvable under the statutory requirements. FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study. This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies. FDA will use this information, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency's assessment of the reliability of the data.

Document History

April 1, 2020
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
April 1, 2019
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
April 1, 2018
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
April 1, 2017
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
21 CFR PART 54
April 1, 2016
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
April 1, 2015
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...
April 1, 2014
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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...

References

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