What is it? Why is it important?

In order to protect against data loss, regular data back-ups should be performed.


Data loss can occur due to:

  • System failure (e.g. power, hardware, software)
  • Environmental conditions (e.g. fire)
  • A virus or hacker attack
  • As a result of human error or malice


Recovery includes processes by which:

  • An occurred problem is repaired and server function is restored
  • Lost data is retrieved
  • Data collection and data input is again possible

What do I need to do?

As a SP-INV, define back-up and recovery procedures such as:


  • Recovery point: Sets the acceptable interval for data back-up (e.g. every 6, 24, 48 hours)


  • Maximum recovery time: Sets the required time needed to restore lost data. Ideally, this should be within 24 hours in order for the study to continue its activities


  • Mirror backup: Requires that copies of backed-up study data are kept in a remote place separate from the server location. This would potentially prevent universal data loss due to fire or flood at the local study site or at server location

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 5.5. Trial Management, data handling, and record-keeping
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Server Management ↦ Back-Up and Recovery

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): Concept ↦ Data Handling ↦ Server Management ↦ Back-Up and Recovery

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