Completion↦Data Handling↦Data Export↦Data Formatting and Tranfer
What is it? Why is it important?
Data formatting and transfer are required procedures performed on the dataset in order to ensure that:
- The information in the exported dataset corresponds to the original data before it was exported from the database
- The exported and transferred dataset has been fittingly formatted, in order to be correctly read and viewed by an alternative system (e.g. statistical program, an alternative CDMS system)
- Any data transfer is performed in a secure and protected manner
Sometimes, the DMan needs to process data before the statistical analysis (e.g. data derivations such as score calculations). Of note, FDA requires data in the CDISC format.
Data to be transferred should be secured and encrypted in such a way as to ensure that no unauthorised person has access to the dataset.
Data transfer by e-mail should be avoided. A more safe and protected transfer environment should be used, such as:
- Through a special web service that incorporates an encryption algorithm in the data to be transferred
- Using a secured-file-transfer-protocol hosted by institutional servers
- Using a CDMS with secure uploading and file sharing functionalities
What do I need to do?
- Check if the study CDMS offers file transfer functionalities
- Consult with DMan regarding the setup of a secure file transfer system
- Ensure transferred data has been properly anonymised
As a DMan:
- Evaluate compatibility between target system and study database
- Based on requirements make appropriate adaptations (e.g. naming of variables, use of coding systems)
- Ensure that data destined for statistical analysis is correct and of high quality (e.g. check for accuracy, unbroken randomisation or treatment codes, data is anonymised)
- Plan the export-import process and potential use of intermediate systems (e.g. Excel)
- Document export time and date including the version of the database that was exported
Specific rules apply when de-identifying or anonymising data (e.g. removing of some data, shifting of dates such as a hospitalisation date). Some CDMS provide functionalities enabling the anonymisation of data exports.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH-GCP E6(R2) – see in particular guidelines
- 5.5. Trial management, data handling, and record-keeping