What is it? Why is it important?
Study monitoring requirements are:
- Is performed by a site independent monitor on behalf of the SP-INV
- Findings are documented in a monitoring report to be reviewed and approved by the SP-INV of the study
- Findings are assessed and improvement measures are implemented
A study monitor:
- Is in most cases the main line of communication between SP-INV and study site
- Is independent of the study site being monitored including any study activities to be monitored
- Reports ongoing study progress, including recorded irregularities at the study site, to the SP-INV
- Supports the study site to ensure compliance with the study protocol, GCP, and applicable laws and regulations (e.g. HRA , swissethics guidelines)
What do I need to do?
Define which Swiss law is applicable to your study.
Monitoring activities are:
- Mandatory for studies conducted under the ClinO
- Allowed but not required for studies conducted under the HRO
When deciding to include a monitor in your study:
- Make sure you employ a qualified monitor
- Write an SOP that describes monitoring procedures, including respective staff responsibilities (e.g. how to plan, set up, and conduct study monitoring)
The SP-INV can delegate monitoring activities to a private CRO or to one of the public CTUs. In that case, it is the responsibility of the delegated party to provide applicable monitoring SOPs, including the monitoring plan of the study.
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 guideline
- 5.18 Monitoring activities
ISO 14155 Medical Device – see in particular section
- 9.2.4 Monitoring (access liable to costs)
HRA – search for “good practice
ClinO – see in particular article
- Art. 5 Rules of GCP