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2nd ICH E6(R3)
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DATA GOVERNANCE
Thursday September 5, 2024 11:45am - 12:15pm EDT
Examine the Significant Expansion of Sponsor Responsibilities Related to Clinical Data Governance and Data Quality
Discuss the sponsor’s responsibility to define the required data quality
Understand the regulatory expectations and the sponsor’s partnership with investigator(s)
Outline considerations for maintaining integrity for blinded studies
Review guidance for the phases of the data lifecycle and supporting attributes like metadata and audit trails
Outline finalization steps to prepare for study analysis
Thursday September 5, 2024 11:45am - 12:15pm EDT
Available On-Demand - Must Participate LIVE to Engage with Speakers
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