What is it? Why is it important?
During study conduct, the monitor checks the quality and integrity of the study data.
With respect to DM responsibilities, the monitor:
- Checks whether data entry is correct and recorded in a timely manner
- Recorded entries in the database correspond to SD (original data entries)
- Data entries are done in close proximity to participant visits
- Writes queries in the event of data inconsistencies or errors
- Supervises query resolution by study site
- Reports any inconsistencies to the SP-INV in order to define applicable corrective actions
- Checks upon subsequent monitoring visits the implementation of any outstanding corrective actions
The requirement for study monitoring is based on regulatory requirements defined according to study type (ClinO or HRO) and risk category (A low risk, B or C high risk).
The SP-INV decides on the:
- Frequency and type of monitoring (e.g. one or several spaced monitoring visits, on-site or central monitoring)
- The extent of monitoring (e.g. what data to check) and scope of data to be monitored (e.g. all collected data, only a given percentage of data)
The MP of the study must be submitted for approval to the EC prior to study start. This includes any subsequent changes or adaptations thereof.
What do I need to do?
Based on study risk and complexity make yourself familiar with the monitoring requirements of your study and how it affects DM aspects.
Topics to evaluate are:
- The management of monitor access to study data and the maintenance of data protection aspects (e.g. the monitor acts on behalf of the study SP-INV and is not granted access to participant identifiers at a given study site)
- Documentation of query management (e.g. upload of query questions, query handling by study site, query resolution or pending issues)
For more information refer to Monitoring in this Study Guide.
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
- Art. 1.38 Monitoring
- Art. 5.5 Trial Management, data handling, and record-keeping
- Art. 5.18 Monitoring activities
ClinO – see in particular article
- Art. 5 Rules of Good Clinical Practice.