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What is the purpose of the financial disclosure form?

Financial disclosure reports are used to identify potential or actual conflicts of interest.

What is Section 505 O )( 3 )( E )( II of the FDCA?

Section 505(o)(3) of the Act authorizes FDA to require postmarketing studies or clinical trials at the time of approval or after approval if FDA becomes aware of new safety information.

What is the FDA 3454 form used for?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: no clinical studies were performed to test this device.

What is FDA Form 3674 used for?

To docHub compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions.

What is Section 402 J of the Public Health Service Act?

delegates the authority contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)). Serious adverse event means an adverse event that results in any of the following outcomes: Death, a life-threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or.

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What is the protocol document for clinical trials?

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

What is FDA 3455 form?

FDA 3455 (PDF - 673KB) Disclosure: Financial Interest and Arrangements of Clinical Investigators.

What is FDA 3455 form?

FDA 3455 (PDF - 673KB) Disclosure: Financial Interest and Arrangements of Clinical Investigators.

What is the difference between FDA Form 3455 and 3454?

Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is docHub.

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What is the purpose of the financial disclosure form?

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What is the protocol document for clinical trials?

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