What is it? Why is it important?

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.


More safe and protected transfers include:

  • Special web services that incorporate 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?

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


Receivers of transferred data should perform validation tests to ensure the imported data corresponds to the original dataset, and that transfer procedures did work as intended.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


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

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

CDISC - provides clinical data interchange standards 

  • CTU – Clinical Trials Unit
  • CDISC – Clinical Data Interchange Standard Consortium
  • CDMS – Clinical Data Management System
  • DMan – Data Manager
  • FDA – Food and Drug Administration
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor Investigator
Completion ↦ Data Handling ↦ Data Export ↦ Data Formatting

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Data Handling ↦ Data Export ↦ Data Formatting

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