What section of the 1572 is required for sub investigators?

Field 6: NAMES OF SUBINVESTIGATORS The purpose of Field 6 is to capture information about individuals who, as part of an investigative team, will assist the investigator and make a direct and significant contribution to the data.

When should Form 1572 be updated?

If there are any changes to the information on the signed and dated 1572, the investigator must document the changes in the study records and update the sponsor. The sponsor must update the IND ingly. However, the 1572 does not need to be edited and a new one is not required.

Can you use an expired 1572?

information and guidance sheet. expired version is the only one available on the website, it is acceptable to use the expired form.

What is the 1572 rule?

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 the alternative to 1572?

In cases where the waiver is granted or the investigator is part of non-IND study, Form 1572 could be replaced with investigator commitment letter and this would comply with 21 CFR 312.20.

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.

How often does a 1572 need to be updated?

However, the 1572 does not need to be edited and a new one is not required. The sponsor can collect certain information and implement them to the IND. Examples of such information are an amendment or protocol amendment.

Does FDA Form 1572 expire?

Form Approved: OMB No. 0910-0014 Expiration Date: March 31, 2022 See OMB Statement on Reverse.

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Fda Form 1572 Continuation Page 3

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