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Protocol Amendment Form Investigators are required to inform the Academic Dean and the Institutional Review Board (IRB), in writing, of protocol changes prior to their initiation. Protocol Title:

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What is protocol amendment form?

The protocol amendment form is a document that is used to make changes to an existing protocol in a research study or clinical trial.

Who is required to file protocol amendment form?

The individuals or organizations conducting the research study or clinical trial are required to file the protocol amendment form.

How to fill out protocol amendment form?

The protocol amendment form should be filled out by providing all the necessary information regarding the changes to be made in the protocol, including details about the reason for the amendment and any potential risks or benefits.

What is the purpose of protocol amendment form?

The purpose of the protocol amendment form is to ensure that any changes made to a research study or clinical trial are properly documented and reviewed to maintain the integrity and safety of the study.

What information must be reported on protocol amendment form?

The protocol amendment form must include details about the changes being made to the protocol, the reason for the amendment, any updated informed consent forms, and any potential risks or benefits associated with the changes.

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