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T&E COMMITTEE #12 February 14, 2019MEM ORA CDU February 12, 2019, TO:Transportation and Environment (T&E) CommitteeFROM:Glenn Olin, Deputy DirectorSUBJECT:Amendments to the FYI 924 Capital Improvements
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CIP amendments refer to changes or updates made to the Clinical Investigation Plan (CIP). These amendments are necessary to reflect new information or changes in the study protocol.
Any sponsor or investigator involved in a clinical trial that requires changes to the original CIP must file an amendment.
CIP amendments should be filled out by clearly documenting the changes and justifications, often using a specific format outlined by regulatory bodies, ensuring all relevant details are included.
The purpose of CIP amendments is to ensure that all stakeholders have the most up-to-date information regarding the study, enhancing compliance with regulatory requirements and maintaining participant safety.
CIP amendments must report information including the nature of the change, reasons for the amendment, and any impacts on study design, timelines, or participant safety.
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