What is it? Why is it important?
Monitoring oversees the progress of a study in order to ensure that:
- Participant safety, rights, and well-being are protected
- The quality and integrity of study data is guaranteed
- Non-compliance is documented and resolved
- The study is conducted in compliance with the study protocol, SOPs, GCP, and applicable laws and regulations
The extent of monitoring is adapted according to study risk(s) and type of study under the law (e.g. ClinO versus HRO).
What do I need to do?
- Select type of monitoring (e.g. centralised, on-site, or a combination of both)
- Prepare the MP, which documents the monitoring strategy (e.g. extent and nature of monitoring)
- Appoint a monitor who
- Has relevant scientific knowledge and experience
- Is independent of the study
- The Site-INV provides the monitor with all required documents needed during monitoring
- In case monitoring is outsourced, set up a contract
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, 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 Study monitoring
ISO 14155 – see in particular section
- 8.2.4 Monitoring (access liable to costs)
HRA – search for “good practice”
ClinO – see in particular article
- Art. 5 Rules of GCP