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Why is financial disclosure required under the FDA review process?

Financial interest of a clinical investigator is one potential source of bias in the outcome of a clinical study. To ensure the reliability of the data, the financial interests and arrangements of clinical investigators must be disclosed to FDA.

What are financial disclosures?

A Financial Disclosure Statement is a document in which the party completing it should report all of his or her income, assets, debts and expenses. Spouses rely on the information reported in order to arrive at a fair division of assets and debts and income.

Which is known as financial disclosure form?

TO BE COMPLETED BY INVESTIGATOR. Collection of this information is authorized under 21 CFR 54.4. The use of this information is to disclose or certify information concerning the financial interests of the clinical investigators associated with clinical studies.

Why is financial disclosure required under the FDA review process?

Financial interest of a clinical investigator is one potential source of bias in the outcome of a clinical study. To ensure the reliability of the data, the financial interests and arrangements of clinical investigators must be disclosed to FDA.

What are financial disclosures?

A Financial Disclosure Statement is a document in which the party completing it should report all of his or her income, assets, debts and expenses. Spouses rely on the information reported in order to arrive at a fair division of assets and debts and income.

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What is a financial disclosure form in clinical trials?

Financial disclosure is the submission of information concerning compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies.

What is the purpose of financial disclosure?

Financial disclosure is required of public officials and employees because it enables the public to evaluate potential conflicts of interest, deters corruption, and increases public confidence in government.

What are financial disclosures?

A Financial Disclosure Statement is a document in which the party completing it should report all of his or her income, assets, debts and expenses. Spouses rely on the information reported in order to arrive at a fair division of assets and debts and income.

Who needs to complete a financial disclosure form in clinical trials?

4.1 Each clinical investigator /sub-Investigator must submit either a completed financial disclosure statement attesting to the absence of financial interests/arrangement or disclose any financial interests/arrangements and steps taken to minimize the potential for bias.

What is an example of a disclosure?

Disclosure is defined as the act of revealing or something that is revealed. An example of disclosure is the announcement of a family secret. An example of a disclosure is the family secret which is told.

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Why is financial disclosure required under the FDA review process?

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What is a financial disclosure form in clinical trials?

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