What is it? Why is it important?

The set-up of the study database is ready once:


Once the database is set-up, validation tests are implemented to ensure the database performs according to required specifications. Upon successful validation the database can be put into productive operation.


Productive or real-life data entry is only possible:

  • Upon successful testing of the database with dummy data
  • The SP-INV has validated and deemed the database fit for productive data entry (the switch from test phase to productive phase must be approved by the SP-INV in writing)
  • Study staff has been trained on data entry procedures and been given access through individualised passwords and logins


The switch from a test to a productive database must be documented. This is automatically tracked in an electronic database.


Example of database version management

  • Version tracking is documented using 3 digits
  • The first release is given the number 1.0.0
  • Small changes result in adaptations in the 3rd digit (e.g. 1.0.1, 1.0.2, 1.0.3)
  • Medium changes result in adaptations in the 2nd digit. (e.g. 1.1.0, 1.2.0, 1.3.0)
  • Major changes result in adaptations in the 1st digit (e.g. 1.0.0, 2.0.0, 3.0.0)

What do I need to do?

As a SP-INV:

  • Ensure requirements needed for the development of the study database are met (e.g. selection of CDMS, protected server location, qualified staff)
  • Implement database according to specifications given in the study protocol (e.g. study design, variable selection, planned study visits)
  • Perform functionality tests exclusively with dummy data:
    • On the non-released database
    • Include staff with regard to functionality tests, as they might more easily identify inconsistencies
  • Once functionality tests have been successfully completed:
    • Release the database in order to allow for productive or real life data entry
    • Provide secure logins to staff responsible for study data entry
  • Ensure the database is provided with a release date and version number


Database validation tests should be performed diligently until data entry performs as intended, without delays or problems. It will save time and resources later on during study conduct.


Changes to an already released database might require a protocol amendment (e.g. changes in inclusion/exclusion criteria, changes in study methods or data collection).


A substantial protocol amendment will result in:

  • An analysis and a  risk assessment in order to ensure that data quality, of already collected data, is not jeopardised
  • Requied submission and approval by EC and if applicable RA
  • A significant delay in study conduct
  • The potential need for additional resources (e.g. staff, infrastructure, partners)
  • An increase in overall study cost

Where can I get help?

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

External Links

Swissethics – search text

  • Definition of substantial and non-substantial amendments


ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • RA – Regulatory Authorities
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Data Handling ↦ Database Set-Up ↦ Requirement

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): Set-Up ↦ Data Handling ↦ Database Set-Up ↦ Requirement

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