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PROTOCOL CHANGE IN STATUS FORMINSTRUCTIONS AND INFORMATION: If you are requesting a change in the status of your study, and you are not submitting the change in status in conjunction with a modification
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Protocol change in status refers to any modification or update made to a protocol's current status or conditions.
The individual or entity responsible for overseeing the protocol, such as the principal investigator or project manager, is typically required to file a protocol change in status.
Protocol change in status forms can usually be filled out online or in hard copy, following the instructions provided by the responsible regulatory body or organization.
The purpose of filing a protocol change in status is to ensure that all stakeholders are aware of any modifications to a protocol, which can impact the conduct of the research or project.
The information required to be reported on a protocol change in status typically includes details of the modification, the reason for the change, and any potential impacts or risks associated with the update.
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