What is it? Why is it important?
Monitoring should be risk-based. This means that the extent of monitoring activities should be adapted according to expected study risks (e.g. study complexity, inclusion of vulnerable participants, experience of site study team).
Monitoring activities should be supervised by an experienced professional.
The extent of study monitoring required is defined by inherent study risks, such as:
- Higher-risk studies (e.g. category B or C versus A)
- Inclusion of vulnerable population (e.g. children or adolescents, patients without capacity, pregnant women, participants with legal guardians)
- Complexity of study design (e.g. randomized, blinded, placebo, cross-over)
- Large numbers of recruited participants
What do I need to do?
Familiarise yourself with GCP, which gives detailed guidance on how to organize and implement the monitoring of your study, including:
- Selection and qualification of monitors
- Extent and nature of monitoring
- Monitor’s responsibilities
- Monitoring procedures
- Monitoring report
- Monitoring plan
In order to ensure GCP knowledge and compliance, the study SP-INV is required to have adequate documented GCP training.
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
- 4.5 Protocol compliance
- 5.18 Monitoring activities
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 6.7 Monitoring plan
- 9.2.4 Monitoring
ClinO – see in particular article
- Art. 19 - 20 Study categorisation
HRO – see in particular article
- Art. 7 Research categorisation