Study Plan and Report
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Study Plan does not have a Sponsor Study number within it, can this be added to the front page of a GLP report without a need for an amendment?
I assume you have not issued the report and therefore we are not amending the final report.
The report will contain the study identify (your study number) under which the study was conducted. The addition of the Sponsors study identifier in the report is not changing any of the study data. In such circumstances I would not see the need to issue a study plan amendment.
RQA GLP Committee
Thank you Tim, for your response. We agree with your response, and also assume that the report has not been finalised at this time.