What is it? Why is it important?

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.

What do I need to do?

  • 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

Where can I get help?

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

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
Abbreviations
  • CTU – Clinical Trials Unit
Conduct ↦ Data Handling ↦ Data Handling ↦ Intermediate Data Eport
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Data Handling ↦ Data Handling ↦ Intermediate Data Eport

Please note: the Easy-GCS tool is currently under construction.