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Conn Health Office of Clinical & Translational Research Standard Operating Procedures Title: Clinical Trial Closeout Relates to Policy/Procedure: 200610 SOP#: 70209 Prepared by: C. People, J. Fine,
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What is office of clinical amp?
Office of Clinical Amendment is a form used by clinical trial sponsors to report changes to their study protocol or investigational plan.
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The clinical trial sponsor is required to file the office of clinical amendment.
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The office of clinical amendment can be filled out electronically through the appropriate regulatory authority's online portal.
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The purpose of the office of clinical amendment is to ensure that any changes to the study protocol are properly documented and approved.
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The office of clinical amendment must include details of the proposed changes to the study protocol, the rationale for the changes, and any potential impact on study participants.
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