Your Easy Guide to Clinical Studies

The study database stores data but does not analyse data. To answer the study question, data must be statistically evaluated. This requires data to be transferred to a statistical tool.

Data transfer might hold the risk that data is changed, deleted or wrongly translated by the data importing system.

In order to retain confidence in the accuracy of study results, database data must be identical to data used during a statistical analysis.

• Ensure data destined for statistical analysis is of high quality (e.g. checked for accuracy, is current and complete)
• Plan the export process and potential use of any intermediate transfer systems (e.g. excel)
• Evaluate compatibility between statistical tool and study database. Make appropriate adaptations (e.g. naming of variables, use of coding systems)
• After import into another system (e.g. statistical software) perform validation tests to ensure imported data corresponds to the data originally exported from the study database
• Document export time, date and version of the database from which the data was exported

Your local CTU can support you with experienced staff regarding this topic.

References

ICH GCP E6(R2) – see in particular guidelines

• 5.5. Trial Management, data handling, and record-keeping