Conduct↦Data Management↦Data Processing↦Data Translation
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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 5.5. Trial Management, data handling, and record-keeping