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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.5. Trial Management, data handling, and record-keeping