Pa 1572 2009 form-2025

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The document provides instructions for completing the Resource Assessment Form (PA 1572) for couples where one spouse is in a nursing facility or receiving Home and Community Based Services (HCBS). It outlines the importance of protecting a portion of the couple's resources under Medical Assistance (MA) guidelines, particularly for the community spouse. The form is used to assess which resources can be protected and what must be spent before applying for MA benefits. It includes detailed verification requirements for various types of resources and emphasizes the need for accurate documentation.

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When to submit 1572 to FDA?

Please note that a 1572 must be submitted to the FDA within 30 days of the investigator being added and when changing any site information, i.e., IRB, laboratory, or clinical site.

What is the purpose of the FDA form 1572?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

What is a PA 1572 form?

The purpose of this Resource Assessment Form is to determine how much of a married couples total resources may be protected or set aside for the community spouse, and how much, if any, must be spent before the individual in the nursing facility or assessed eligible for HCBS may be eligible for Medical Assistance

What is the 1572 rule?

Under FDA regulations, a 1572 is only required for studies of investigational drugs and biologics conducted under an IND. It is not required for studies that are not done under an IND and is not applicable to investigational device studies.

What is the most important part of 1572?

Form FDA 1572 serves two main purposes: The first is to provide the sponsor with the investigators qualifications and information about the clinical site. The second purpose is to inform and clarify the obligations of the investigator and to acquire investigators commitment to follow pertinent FDA regulations.