Get the free Form FDA 1572 - Food and Drug Administration - gpo

FDA 1572 (21 CFR 312.53(c)). 1. NAME AND ADDRESS OF INVESTIGATOR. Name of Principal Investigator. Address 1. Address 2. City. State/Province/Region ...

How to fill out form fda 1572

How to fill out form FDA 1572:

1. Begin by downloading form FDA 1572 from the official FDA website or obtain a physical copy from your clinical trial coordinator.
2. Fill in the first section of the form, which includes the title of the study, the name and address of the clinical investigator, and the name and address of the research site where the study will be conducted.
3. Provide the protocol title and the protocol number if it has been assigned. The protocol is a detailed plan outlining the objectives, methodology, and procedures of the clinical trial.
4. Indicate the name and address of the sponsor or the individual responsible for financing and managing the clinical trial.
5. Provide the name and contact information of the medical or clinical expert overseeing the trial. This is typically the principal investigator.
6. Complete the financial disclosure section, which requires you to disclose any financial interests or arrangements that could potentially influence the study results.
7. Sign and date the form to certify that the information provided is accurate and complete. Additionally, the form must be signed by the clinical investigator's immediate supervisor or another authorized official.

Who needs form FDA 1572:

1. Clinical investigators who are conducting or planning to conduct a clinical trial in the United States under an Investigational New Drug (IND) application.
2. Sponsors or individuals responsible for financing and managing the clinical trial.
3. Institutional review boards (IRBs) or independent ethics committees (IECs) that review and approve the study protocol.

The form FDA 1572 is a crucial document for ensuring compliance with FDA regulations and facilitating the collection of reliable and credible data during clinical trials.

For pdfFiller’s FAQs

What is form FDA 1572?

Form FDA 1572 is a statement of investigator form that is used in clinical trials to document the investigator's agreement to conduct the study in accordance with FDA regulations.

Who is required to file form FDA 1572?

Investigators conducting FDA-regulated clinical trials are required to file Form FDA 1572.

How to fill out form FDA 1572?

Form FDA 1572 should be filled out by the investigator and signed in ink. The form requires basic information about the investigator, study title, study protocol, and agreement to comply with FDA regulations.

What is the purpose of form FDA 1572?

The purpose of Form FDA 1572 is to document the investigator's agreement to conduct a clinical trial in accordance with FDA regulations.

What information must be reported on form FDA 1572?

Form FDA 1572 requires information such as the investigator's name, address, qualifications, site information, protocol title, and signature.

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