Unclear boundaries between investigator-controlled and sponsor-managed data in IRT systems are creating avoidable compliance risk, particularly around investigational product inventory and quality actions.
Mohammed Najmul Hasan, MPharm
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Clinical Trial Supply Manager, Novartis
Articles by Mohammed Najmul Hasan, MPharm
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Clarifying Ownership of IRT Data in Clinical Trials: Distinguishing Investigator-Controlled Data from Sponsor Operational DataPublished: January 2nd 2026 | Updated:
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