Your Easy Guide to Clinical Studies

Data formatting (e.g. variable specifications) are required procedures in order to ensure that:

• The information in the exported dataset corresponds to the original data in the study database. Sometimes, the study Data Manager (DMan) needs to process data before being exported for statistical analysis (e.g. data derivations such as score calculations).
• 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. The FDA requires data to be documented in a CDISC format)

 

Data exports and transfers must be secure and encrypted in such a way so as to ensure that no unauthorised person gains access to the dataset. Some CDMS provide functionalities enabling the anonymisation of data exports. Data transfer by e-mail should be avoided.

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As a SP-INV define data export procedures in a SOP or WI. In collaboration with the study DMan:

• Check if the study CDMS offers file transfer functionalities
• Consult with the DMan regarding the setup of a secure file transfer system
• Ensure that data to be transferred has been properly anonymised
• Ensure that data destined for statistical analysis is correct and of high quality (e.g. check for accuracy, unbroken randomisation or treatment codes)

 

As a DMan:

• Evaluate compatibility between target system and the study database
• Make appropriate adaptations to the dataset based on requirements (e.g. naming of variables, use of coding systems)
• 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

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References

ICH-GCP E6(R2) – see in particular guidelines

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

CDISC - provides clinical data interchange standards