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Why does it say that and why can’t it say this? Managing sponsor input when reporting a nonclinical laboratory study and ensuring the study director is independent

06 Apr 2025

SQA 2025 -- A nonclinical laboratory study was conducted following the Sponsor-approved protocol and the data has been collected. As the Study Director tabulates the data and draws their conclusions, the Sponsor asked to review drafts of the main study report and all principal investigators/contributing scientist reports. The Sponsor is trying to revise what the Study Director reports, including modifying the conclusions. The Study Director is asking for assistance regarding what can and cannot be changed, while remaining compliant and while keeping the Sponsor informed.