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

More

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)

More

  • 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

References

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

  • 5.5. Trial management, data handling, and record-keeping
Abbreviations
  • CTU – Clinical Trials Unit
  • CDISC – Clinical Data Interchange Standard Consortium
  • CDMS – Clinical Data Management System
  • DMan – Data Manager
  • FDA – Food and Drug Administration
Completion ↦ Data Handling ↦ Data Export ↦ Data Formatting and Tranfer
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): Completion ↦ Data Handling ↦ Data Export ↦ Data Formatting and Tranfer

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