What is it? Why is it important?
Quality Management includes a set of activities, processes, and implemented measures that ensure that study data is of high-quality.
- Is within the responsibility of the SP-INV who must guarantee the quality of all collected study data (variables)
- Depends on whether data was correctly documented, collected, handled and analysed. As a consequence, data handling processes and guidelines should be in place
- Is important because it grants confidence that given study results are reliable and credible
When implementing data quality measures, a risk-based approach should be used.
A risk-based approach includes to:
- Identify potential risks to data quality (e.g. documentation errors, data input errors, incompatible software updates, untrained staff responsible for data input)
- Evaluate risks and their likelihood of occurrence, ability to be detected and expected impact on data quality
- Based on risk evaluation prioritise risks and define risk control measures
- Plan periodic risk reviews during study conduct so as to
- Evaluate the ongoing efficiency of any implemented mitigating measures
- Identify new risks
What do I need to do?
Means to ensure data quality include:
- The identification of potential risks that might negatively affect your data, including strategies able to mitigate these risks
- The introduction of respective processes and supporting documents (e.g. SOPs, WIs, checklists)
- Establish responsibilities and train study staff on data handling procedures, mitigating measures and its ongoing effectiveness during study conduct
- Means to personalise CDMS setup in order to support ongoig data quality
- Monitor correct data collection, processing and handling procedures. Plan a risk-based monitoring strategy applicable to the study
- As required perform system validation and functionality testing
- Ensure ongoing system maintenance and security, including ongoing data backup and recovery due to system failure
- Applicable archiving procedures
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.1 for Quality assurance and control
- 5.5. Trial Management, data handling, and record-keeping
ISO 9001:2015 – Quality Management Systems – Requirements