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Deviation-Driven Updates to Site SOPs How Protocol Deviations Should Trigger Site SOP Revisions Introduction: Connecting Protocol Deviations to SOP Updates Standard Operating Procedures (SOPs) are foundational to consistent, compliant operations at clinical trial sites. However, SOPs cannot be static documents. As protocol deviations occur and root causes are uncovered, SOPs must evolve accordingly. In fact,…
Tracking Protocol Deviation Frequency as a Quality Metric in Clinical Trials In the complex world of clinical trials, ensuring strict adherence to the study protocol is critical to maintaining data integrity, patient safety, and regulatory compliance. Protocol deviations — defined as any instance where trial conduct diverges from the approved protocol — are inevitable but…
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