Validating electronic source data clinical trials

However, the validation process is complex and dependent on the data captured, business and regulatory concerns, the data management software used, and several other factors, so there are many possible variations and options.The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor.Regardless, 98% of respondents currently report challenges with their clinical data management systems, indicating that companies will need to be better prepared to collect and analyze the growing volume of real-world patient data available from a variety of sources, the study surmises.According to the study, life sciences companies use an average of four data sources in clinical trials today.

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This includes the built-in possibilities for configuration.As a result, the EMA explains that the GCP inspectors receive an increasing number of questions with regard to this topic.In addition, the EMA calls attention to the fact that deviations were given during GCP inspections, regarding the level of validation/qualification needed to be performed by a sponsor when using a system that has already been validated by the supplier.Disambiguation: Clinical data validation means checking clinical data for correctness and completeness.Clinical database validation is making sure that clinical databases perform the functions required by regulations and guidances and is on another page.

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