QualityGlossary Term
ICH E6(R3) Section 5.18
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.
Source document verification represents a fundamental quality control activity in clinical trials, ensuring that data entered into case report forms accurately reflects the original observations and measurements recorded in source documents. Through direct comparison of CRF entries against medical records, laboratory reports, and other source materials, monitors can identify transcription errors, data entry mistakes, and inconsistencies that might otherwise compromise data integrity.
The extent and approach to SDV has evolved significantly with the adoption of risk-based monitoring principles. Traditional monitoring practices often emphasized 100% SDV of all data points, requiring monitors to verify every entry against source documents during on-site visits. Current guidance, reflected in ICH E6(R3), recognizes that this approach may not be the most efficient use of monitoring resources and may not effectively identify critical issues that affect participant safety or trial endpoints.
Risk-based approaches to SDV focus verification activities on data most critical to participant safety and the primary endpoints of the trial. Statistical sampling techniques may be used to assess overall data quality without reviewing every data point. Centralized monitoring activities can identify sites or participants with unusual data patterns warranting focused review. This evolution does not diminish the importance of data accuracy but rather applies resources more strategically to ensure that verification activities address the most significant risks to trial integrity.
Monitoring visit
"During SDV, the monitor identified that the hemoglobin value entered in the CRF was 12.5 g/dL while the laboratory report showed 15.2 g/dL, indicating a transcription error that required correction."
Risk-based approach
"Based on the monitoring plan's risk assessment, the CRA performed 100% SDV on primary efficacy endpoints and adverse events but verified only a 20% sample of other data points."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
ICH E6(R3) Section 5.18
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.
Source document verification represents a fundamental quality control activity in clinical trials, ensuring that data entered into case report forms accurately reflects the original observations and measurements recorded in source documents. Through direct comparison of CRF entries against medical records, laboratory reports, and other source materials, monitors can identify transcription errors, data entry mistakes, and inconsistencies that might otherwise compromise data integrity.
The extent and approach to SDV has evolved significantly with the adoption of risk-based monitoring principles. Traditional monitoring practices often emphasized 100% SDV of all data points, requiring monitors to verify every entry against source documents during on-site visits. Current guidance, reflected in ICH E6(R3), recognizes that this approach may not be the most efficient use of monitoring resources and may not effectively identify critical issues that affect participant safety or trial endpoints.
Risk-based approaches to SDV focus verification activities on data most critical to participant safety and the primary endpoints of the trial. Statistical sampling techniques may be used to assess overall data quality without reviewing every data point. Centralized monitoring activities can identify sites or participants with unusual data patterns warranting focused review. This evolution does not diminish the importance of data accuracy but rather applies resources more strategically to ensure that verification activities address the most significant risks to trial integrity.
Monitoring visit
"During SDV, the monitor identified that the hemoglobin value entered in the CRF was 12.5 g/dL while the laboratory report showed 15.2 g/dL, indicating a transcription error that required correction."
Risk-based approach
"Based on the monitoring plan's risk assessment, the CRA performed 100% SDV on primary efficacy endpoints and adverse events but verified only a 20% sample of other data points."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.