What is it? Why is it important?
This entails that data collected and entered into the study database (eCRF):
- Is according to specifications given in the study protocol
- Originate from real life participants who signed the ICF and agreed to participate in the study
- Correspond to the source-data from where the data was originally collected
- Is not based on fraud with the aim to manipulate study outcome (e.g. invented, changed, copied or adapted data)
Quality data is reproducible data. In other words, data has been collected and managed in such a way that other researchers obtain similar results when repeating the study.
What do I need to do?
- Is based on specifications given in the study protocol
- Correspond to the original source-data
- Stems from participants that have signed the ICF and agreed to participate in the study
- Document potential deviations and define applicable control-measures
- Ensure data corrections and applicable improvement measures are implemented
- Review implemented risk control-measures on in order to protect data integrity and quality on an ongoing basis
Data monitoring can be performed by visiting the study-site, or remotely by gaining access to the study database at a location other than the study site.
When errors are found during data monitoring, the source of the error should be investigated. This is done by starting a query resolution process.
- The monitor raises a query which is forwarded to the site staff of the study
- Once a query is answered by the applicable study staff and the error is corrected, the monitor can close the query
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 guidelines
- 5.5. Trial Management, data handling, and record-keeping