Protocol Amendments

Protocol amendments are formal changes or updates made to an approved research plan or study protocol. They are necessary when new information, regulatory requirements, or unforeseen issues arise, requiring adjustments to ensure the study remains accurate and compliant. These amendments can involve modifying procedures, adding or removing procedures, or updating documentation. They must be reviewed and approved by relevant oversight bodies, such as ethics committees or regulatory agencies, before implementation, ensuring the safety of participants and the integrity of the study are maintained throughout its conduct.