Trusted Resource for Clinical Trials, Protocols & Progress
A query is a request for clarification or correction of data captured in a Case Report Form (CRF). It may arise due to missing, inconsistent, out-of-range, or illogical data entries. Queries are essential for maintaining GMP-compliant data integrity and ensuring that the final database supports valid clinical conclusions.
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A protocol deviation is any instance in which the study conduct diverges from the approved protocol. Deviations may be intentional or unintentional, minor or major, and must be logged and reported appropriately to maintain GMP compliance and Good Clinical Practice (GCP) standards.
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An audit typically evaluates:
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Monitoring visits are structured, scheduled inspections conducted at investigational sites by CRAs. Their purpose is to verify that:
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