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Tag: risk-based monitoring

Monitoring and Auditing in Clinical Trials: Ensuring Compliance, Integrity, and Quality

Posted on May 15, 2025 digi By digi

Monitoring and Auditing in Clinical Trials: Ensuring Compliance, Integrity, and Quality Mastering Monitoring and Auditing for High-Quality Clinical Trials Monitoring and auditing are critical components of clinical research that ensure trials are conducted ethically, comply with regulatory requirements, and produce credible data. Through systematic oversight, clinical monitors (CRAs) and auditors detect deviations, verify data accuracy,…

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Clinical Research Operations, Monitoring and Auditing

Clinical Trial Monitoring Plans: Structure, Strategy, and Best Practices

Posted on May 13, 2025 digi By digi

Clinical Trial Monitoring Plans: Structure, Strategy, and Best Practices Mastering Clinical Trial Monitoring Plans for GCP Compliance and Data Integrity Monitoring is a critical component of Good Clinical Practice (GCP) that ensures clinical trials are conducted ethically, safely, and in accordance with approved protocols. Well-designed monitoring plans help protect participant rights, verify data accuracy, and…

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Good Clinical Practice (GCP) and Compliance, Monitoring Plans

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