What is it? Why is it important?

The study database stores data but does not analyse data. To assess or answer the study question, data must be statistically evaluated. This requires data to be transferred from the study database 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, the transferred data used for the statistical analysis must be identical to the data in the study database.

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What do I need to do?

As a SP-INV in collaboration with the study Data Manager:

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

Where can I get help?

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
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor Investigator
Conduct ↦ Data Management ↦ Data Processing ↦ Data Translation
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Data Management ↦ Data Processing ↦ Data Translation

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