What is it? Why is it important?
The aim of monitoring is to verify or notice particular things.
As in daily medical practice, activities are monitored and inconsistencies are corrected. These processes are especially important when conducting a study.
The purpose of study monitoring is to verify that:
What do I need to do?
As a SP-INV select a study monitor who:
- Is appropriately trained and has experience in study monitoring
- Has relevant scientific knowledge
- Is thoroughly familiar with the study protocol, GCP, study IMP/IMD, including applicable laws and regulations
The study SP-INV is responsible to appoint a qualified study monitor. The SP-INV can delegate monitoring tasks to a contractor/CRO/local CTU, but remains responsible for the quality of any delegated services.
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 guideline
- 5.18 Monitoring activities
ISO 14155 Medical Device – see in particular section
- 9.2.4 Monitoring (access liable to costs)
HRA – see in particular
- Art. 10c Good practice guidelines
ClinO – see in particular article
- Art. 5 Rules of GCP