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clinical trial protocol amendment

A clinical trial protocol is amended when it has been identified that the current protocol version requires modification (e.g. changes to screening or timelines for assessments/procedures). The clinical trial protocol document itself is modified and a new version is created. In addition, a protocol amendment summary document is created that details the rationale for the changes and itemizes the protocol sections to be modified, specifically summa

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22 Other / Other University Of Toronto / ACR103 18 Nov 2020