Trusted Resource for Clinical Trials, Protocols & Progress
Queries are data clarifications raised by the system or data management personnel when a data point appears incomplete, inconsistent, or outside predefined validation rules. They are raised within the Electronic Data Capture (EDC) system and require action—usually from the investigator site.
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The primary goal of a database lock meeting is to obtain cross-functional agreement that the clinical database is:
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A database lock is the point at which the clinical trial data becomes read-only. No further changes can be made to the data unless the database is unlocked under controlled procedures. This ensures data integrity for statistical analysis and regulatory submission.
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Database lock refers to the process by which all data entries in the Electronic Data Capture (EDC) system are finalized and made read-only. At this stage, no further changes can be made unless the database is unlocked under controlled procedures.
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Once a clinical database is locked—meaning it has been frozen to prevent any further changes—several downstream processes are triggered:
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Database lock is the process by which all clinical trial data is finalized, rendered read-only, and certified for statistical analysis. It marks the end of data cleaning and the beginning of regulatory deliverable generation, such as the Clinical Study Report (CSR), integrated summaries, and submission packages.
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Clinical data archiving refers to the long-term storage and protection of documents, datasets, and records generated during a clinical trial. These may include:
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Clinical records include any document, form, image, or dataset used to support the conduct, reporting, and verification of a clinical trial. These may encompass:
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According to ICH GCP E6(R2), clinical trials generate “essential documents” that demonstrate compliance and trial integrity. These documents must be archived to allow reconstruction of the trial, and include:
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Clinical data retention ensures that information generated during the conduct of a study is preserved for:
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