Development↦Quality and Risk↦Quality Control↦Monitoring
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, ICH GCP, Ethics requirements (EC ), applicable laws (e.g. Swiss law), applicable regulatory requirements (e.g. Swissmedic, FOPH), and applicable guidelines (e.g. ISO 14155)
The extent of monitoring is adapted according to study risk(s) and type of study under the law (e.g. ClinO versus HRO).
The SP-INV is responsible for the monitoring of the study, which can be delegated to the CTU or a CRO. Any delegation must be documented in a contract.
What do I need to do?
As a SP-INV:
- Select the type of required monitoring required for your study (e.g. centralised, on-site, or a combination of both)
- Prepare a Monitoring Plan (MP), which documents the monitoring strategy for your study (e.g. extent and nature of monitoring)
- :Appoint a monitor who
- Has relevant scientific knowledge and experience
- Is independent of the study
- In the event study monitoring services are outsourced, ensure to document its strategy, responsibilities, and costs in a contract
Upon a monitoring visit, the Site-INV is responsible to provide the monitor with all the required documents (e.g. quality documents) needed to perform the required Quality Control activities.
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, 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 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