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Posted by Brad Liebermann on Mon, Nov 06, 2017

Financial Disclosure of Equity Interest

The FDA evaluates the disclosure of financial information from clinical investigators to determine the reliability of data submitted to the FDA and identify steps to minimize the potential for bias. The value of an investigator’s financial interest in the sponsor may have the potential to increase if the product is approved. 21 CFR 54 states that investigators must disclose significant equity interest in the sponsor, any proprietary interest in the sponsor and significant payments of other sorts from the sponsor during the time the investigator is carrying out the study and for a period of one year following completion of the study.

Topics: Draft Guidance, Financial Disclosure, FDA

Posted by Brandy Chittester on Fri, Jun 03, 2016

Financial Disclosure – 21 CFR 54 in a Nutshell

When conducting clinical trials, it is of utmost importance that the data generated be free from threats to the validity and integrity of the research. As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. It is not unusual for the innovations of individual physician investigators to receive research and development funding from larger organizations that possess the resources to bring these innovations to market, and under 21 CFR 54, it is the responsibility of sponsors to collect for each investigator who is not a full-or part-time employee either a certification of no financial conflict of interest (Form FDA 3454), or a disclosure of the financial arrangements between the sponsor and investigator (Form FDA 3455). These financial disclosures must be updated by the investigators if there are any changes in financial disclosure status throughout the study, until one year after the study is completed.

Topics: 21 CFR 54, Financial Disclosure, FDA, Clinical Research

Posted by Sandra Maddock on Thu, Jul 19, 2018

Financial Disclosure – 21 CFR 54 in a Nutshell

When conducting clinical trials, it is of utmost importance that the data generated be free from threats to the validity and integrity of the research. As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. It is not unusual for the innovations of individual physician investigators to receive research and development funding from larger organizations that possess the resources to bring these innovations to market, and under 21 CFR 54, it is the responsibility of sponsors to collect for each investigator who is not a full-or part-time employee either a certification of no financial conflict of interest (Form FDA 3454), or a disclosure of the financial arrangements between the sponsor and investigator (Form FDA 3455). These financial disclosures must be updated by the investigators if there are any changes in financial disclosure status throughout the study, until one year after the study is completed.

Topics: 21 CFR 54, Financial Disclosure, FDA Warning Letters

Posted by Brandy Chittester on Wed, Mar 04, 2015

NEW! FDA Guidance on Financial Disclosure

As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. Perhaps more clarity is needed in order for those in the clinical research industry to be brought into compliance with 21 CFR 54?

Topics: FDA Guidance, 21 CFR 54, Financial Disclosure

Posted by John Lehmann on Wed, Mar 04, 2015

Financial Disclosure – 21 CFR 54 in a Nutshell

When conducting clinical trials, it is of utmost importance that the data generated be free from threats to the validity and integrity of the research. As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. It is not unusual for the innovations of individual physician investigators to receive research and development funding from larger organizations that possess the resources to bring these innovations to market, and under 21 CFR 54, it is the responsibility of sponsors to collect for each investigator who is not a full-or part-time employee either a certification of no financial conflict of interest (Form FDA 3454), or a disclosure of the financial arrangements between the sponsor and investigator (Form FDA 3455). These financial disclosures must be updated by the investigators if there are any changes in financial disclosure status throughout the study, until one year after the study is completed.

Topics: 21 CFR 54, Financial Disclosure, FDA Warning Letters

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