What is it? Why is it important?
During study conduct, the study monitor checks among others the quality and integrity of the study data.
With respect to Data Managment (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)
- 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 (e.g. upload of query questions, query handling by study site, query resolution or pending issues)
- 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
What do I need to do?
- Assess the monitoring requirements of your study and how it affects DM aspects
- Establish a requirement profile for a study monitor
- Frequency and type of monitoring (e.g. one or several spaced monitoring visits, on-site or central monitoring)
- Extent of monitoring (e.g. what data to check) and the scope of data to monitor (e.g. all collected data, only a given percentage of data)
For more information refer to Monitoring in this Study Guide.
Planned study monitoring activities are summarised in the Monitoring Plan (MP) of the study. It describes the monitoring strategy by defining scope, frequency and type of monitoring. The MP must be submitted for approval to the EC prior to study start. This includes any subsequent changes or adaptations thereof.
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.