What is it? Why is it important?

Laboratories or other analytical systems generate study data. The ability to import data from these systems into the study database (eCRF) can:

  • Simplify the data collection and documentation process
  • Avoid human transcription errors


Still, as different software systems utilise different means to document and store data, the transfer between different software systems may require significant reformatting efforts.


Thus, the translation of information from one system source to another must be defined prior to any data import. Different software systems commonly have different standards regarding data structure. While the information may be intuitively obvious to a human reader, the same does not always hold true for a computer system.


Required adaptations may include:


Before data import, adaptations should be done by the Data Manager (DMan) in collaboration with the study team. Only correctly formatted data guarantees successful data import into the study database (eCRF).

What do I need to do?

As a SP-INV and in collaboration with the Data Manager (DMan) of your study:

  • Clarify whether data can be exported from a primary system source of interest
  • Collect information on the set-up and structure of the data to be exported (e.g. formatting-, metadata information)
  • Define how:
    • Data must be reformatted in order to be compatible with the study database (eCRF)
    • To validate any reformatted data, based on the requirements of your study database 
  • Perform data import only once the data you plan to import has been appropriately adapted in the primary source


Data manipulation processes:

  • Are time-consuming and have a high error risk if done incorrectly (e.g. incorrect reformatting, the skipping of format validation prior to merging, faulty implemented data merging procedures)
  • Must be documented and reproducible


As these processes can be quiet challenging, it might be advisable to outsource some of these services.

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
  • CTU – Clinical Trials Unit
  • DMan – Data Manager
  • eCRF – Electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
Conduct ↦ Data Handling ↦ Data Handling ↦ Data Import

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): Conduct ↦ Data Handling ↦ Data Handling ↦ Data Import

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