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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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Office of Clinical Amendment is a form used by clinical trial sponsors to report changes to their study protocol or investigational plan.
The clinical trial sponsor is required to file the office of clinical amendment.
The office of clinical amendment can be filled out electronically through the appropriate regulatory authority's online portal.
The purpose of the office of clinical amendment is to ensure that any changes to the study protocol are properly documented and approved.
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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