Tag: data management SOPs

Database Lock Procedures in Clinical Data Management: A Complete Guide

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Database Lock Procedures in Clinical Data Management: A Complete Guide Mastering Database Lock Procedures in Clinical Data Management Database Lock is a critical milestone in Clinical Data Management (CDM), signifying the point where clinical trial data are deemed clean, complete, and ready for final statistical analysis. Properly executed database lock procedures ensure the integrity, traceability,…

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Clinical Data Management, Database Lock Procedures

Data Integrity and ALCOA+ Principles in Clinical Trials: Foundations for Compliance and Credibility

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Data Integrity and ALCOA+ Principles in Clinical Trials: Foundations for Compliance and Credibility Safeguarding Clinical Research: Data Integrity and ALCOA+ Principles Explained Data Integrity and ALCOA+ Principles are the cornerstones of trustworthy, compliant clinical research. Maintaining accurate, reliable, and verifiable data is essential for protecting participant safety, ensuring scientific validity, and securing regulatory approvals. Regulatory…

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Data Integrity and ALCOA+ Principles