Get the free FDA-1572-amend 7&8.doc - acrin

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION STATEMENT OF INVESTIGATOR (TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312) (See instructions on reverse side.) Form Approved:

How to fill out fda-1572-amend 7amp8doc - acrin

How to fill out fda-1572-amend 7amp8doc:

1. Begin by carefully reading the instructions provided with the form. Familiarize yourself with the purpose and requirements of the fda-1572-amend 7amp8doc.
2. Ensure that you have all the necessary information at hand, such as the name and contact details of the investigator, the study site, and the name of the clinical trial.
3. Start by filling out the top section of the form, which includes the title, name of the investigator, and any previous amendments that have been made.
4. Proceed to the amendment section of the form. Indicate whether you are making an amendment to section 7 or section 8, or both. Provide a clear and concise description of the changes to be made in the appropriate section(s).
5. In section 7, provide detailed information about each previously signed investigator. Include their name, address, phone number, and qualifications. Indicate whether they are remaining on the study or being removed, and provide a reason for any changes made.
6. In section 8, provide the same detailed information for each new investigator being added to the study. Include their name, address, phone number, and qualifications. Provide a rationale for their addition to the study, and specify their role and responsibilities.
7. Review the completed form to ensure accuracy and completeness. Make any necessary corrections or additions before submitting it.
8. It's a good practice to consult with your study sponsor or regulatory authority to ensure that you have filled out the fda-1572-amend 7amp8doc correctly and according to their specific requirements.

Who needs fda-1572-amend 7amp8doc?

1. Researchers conducting clinical trials within the United States may need the fda-1572-amend 7amp8doc form. It is required by the U.S Food and Drug Administration (FDA) to document changes or amendments to the investigator information in ongoing studies.
2. Sponsors or institutions overseeing the clinical trials may also need this form to maintain accurate and up-to-date records of investigators involved in the study.
3. Any stakeholders involved in the clinical trial, such as regulatory authorities or ethics review boards, may require the fda-1572-amend 7amp8doc as part of their documentation and oversight processes.

For pdfFiller’s FAQs

What is fda-1572-amend 7amp8doc?

FDA Form 1572 is a document used in clinical trials that states the investigator's commitment to comply with the FDA regulations.

Who is required to file fda-1572-amend 7amp8doc?

Investigators who are participating in FDA-regulated clinical trials are required to file FDA Form 1572.

How to fill out fda-1572-amend 7amp8doc?

FDA Form 1572 must be completed by the investigator with accurate and up-to-date information regarding their qualifications, experience, and commitment to the trial.

What is the purpose of fda-1572-amend 7amp8doc?

The purpose of FDA Form 1572 is to ensure that the investigator understands their responsibilities in conducting the clinical trial and is committed to following FDA regulations.

What information must be reported on fda-1572-amend 7amp8doc?

FDA Form 1572 requires information about the investigator's qualifications, experience, and the site where the clinical trial will be conducted.

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