What is it? Why is it important?

The study database and its electronic CRF can be developed once:

  • An applicable access protected server is available
  • A CDMS complying with regulatory requirements has been selected
  • A final and approved study protocol is available, including its list of required variables
  • Metadata and variable specifications are defined (e.g. by using a codebook)

Once the database is set-up, validation tests are performed to ensure that the eCRF works according to study specifications

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Productive or real-life data entry is only possible:

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

Changes to a productive database must be documented. In an electronic database the tracking can be done by the system itself.

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?

  • 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 during test phase as they might more easily identify inconsistencies
  • Once functionality tests are 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

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

Planed changes to be implemented in a released database might initially require a substantial amendment (e.g. changes in inclusion/exclusion criteria, changes in study methods or data collection).

A substantial amendment will result in:

  • An analysis including an applicable risk assessment in order to ensure that data quality is not jeopardised
  • Submission and approval by EC and if applicable RA
  • A 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 – see in particular

  • Amendments – Definition of substantial and non-substantial amendments

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
Abbreviations
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • eCRF – electronic Case Report Form
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Data Handling ↦ Database ↦ Development
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): Set-Up ↦ Data Handling ↦ Database ↦ Development

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