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?
Tim Stiles 12/01/2021 10:22
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 15/02/2021 12:56
Thank you Tim, for your response. We agree with your response, and also assume that the report has not been finalised at this time.