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 the data is exported for statistical analysis (e.g. data derivations such as score calculations).
• The exported dataset is fittingly formatted, so that once transferred the data can be correctly read and viewed by an alternative system (e.g. statistical program, an alternative CDMS system). As an example, the FDA requires that data destined for export must be in CDISC format (i.e. open standards for the sharing of study data)

 

Some CDMS provide functionalities enabling the:

• Filtering of content according to defined criteria
• Selection of variables to be included in the export
• Inclusion of  metadata in the export  (e.g. last saved timestamp)
• Anonymisation of exported data

More

As a SP-INV define data export procedures in a SOP or WI.

 

In collaboration with the study DMan:

• Consult with a statistician to decide on the required export format (e.g. based on  statistical software)
• Plan data export and implement adaptations based on defined requirements
• Document:
  • Data export time and date
  • The version of the exported database (e.g. document identification)
• Once opened in another system (e.g. statistical software):
  • Make appropriate required adaptations to the dataset (e.g. naming of variables, use of coding systems)
  • Ensure the data-set is of high quality (e.g. check for accuracy, data confidentiality, and that the blinding of the study data is maintained)
  • Document any reformatting and data validation processes

References

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

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

CDISC – provides clinical data interchange standards