Clinical Trial Data Quality Measure
Jump to navigation
Jump to search
A Clinical Trial Data Quality Measure is a data quality measure for clinical trial data.
- Context:
- It can range from being a Quantitative Clinical Trial Data Quality Meausure to being a Qualitative Clinical Trial Data Quality Measure.
- It can be defined by Clinical Trial Data Governance System.
- It can be a Clinical Trial Data Accuracy Measure.
- It can be a Clinical Trial Data Auditability Measure.
- It can be a Clinical Trial Data Availability Measure.
- It can be a Clinical Trial Data Accessibility Measure.
- It can be a Clinical Trial Data Completeness Measure.
- It can be a Clinical Trial Data Consistency Measure.
- It can be a Clinical Trial Data Reusability Measure.
- It can be a Clinical Trial Data Security Measure.
- It can be a Clinical Trial Data Timeliness Measure.
- It can be a Clinical Trial Data Validity Measure.
- It can be a Clinical Trial Data Understandability Measure.
- It can be supported by a Data Verification Rule.
- It can be assessed by a Data Quality Monitoring System (against data quality specifications).
- …
- See: Clinical Study Data.
References
2006
- (Williams, 2006) ⇒ George W. Williams. (2006). “The Other Side of Clinical Trial Monitoring; Assuring Data Quality and Procedural Adherence.” Clinical Trials 3, no. 6
- Background:
Data monitoring can mean different things. It can mean statistical methodologies for clinical trial monitoring, interim data analysis, monitoring for quality control or assurance or safety reporting to regulatory agencies. - Purpose:
The various facets of data monitoring will be discussed and reviewed from primarily an industry perspective. - Methods:
By careful attention to the design and conduct of a clinical trial, the expense of monitoring can be markedly reduced. Careful attention should be given to the qualifications of investigators in the selection of clinical sites and central facilities. Site personnel must be adequately trained. The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial. The monitor should visit the investigator at the site of the investigation frequently enough to ensure acceptable quality. The monitor is responsible for inspecting the case report forms at regular intervals. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. The auditor will assess whether the site is being monitored in accordance with the monitoring plan. The determination of the extent and nature of monitoring should be based on considerations such as the objective, design and complexity of the trial. Statistical sampling may be an acceptable method for selecting the data to be verified. The monitor should ensure that adverse events are reported. Study data will be monitored on an ongoing basis to ensure patient safety. The sponsor may utilize a Data Monitoring Committee to protect the validity of a trial.
- Background: