What is it? Why is it important?
During on-site monitoring the monitor personally visits the site to be monitored.
During on-site visits, the monitor has access to and can check the following information or documents:
- Existence of study participants and proof of their agreement to participate in the study (e.g. singed ICF)
- Participant eligibility criteria: every participant fulfils study inclusion/exclusion criteria (e.g. source data (SD) verification (SDV))
- Database: Entries made in the study database (eCRF) correspond to original data in medical records (e.g. source data verification (SDV))
- Whether the filing of required documents is complete such as:
- IMP/MD handling: inventory, storage conditions, and access rights
The monitor performs the monitoring visit according to the monitoring plan, which defines extent of monitoring and tasks to be performed.
What do I need to do?
As a monitor define on-site monitoring tasks, such as whether:
- Participants (e.g. or their legal representative) have dated and signed the ICF and study procedures start only after the participant has signed the ICF
- Participants fulfil study inclusion and exclusion criteria based on their medical records
- Data are correctly entered in the study database (eCRF)
- Essential documents are filed in TMF/ISF
- Only documents approved by EC/RA (e.g. Swissmedic) are used
- IMP/MD is stored according to specifications (e.g. temperature)
While monitoring, the monitor may ask the following questions:
- Have all participants agreed to participate in the study? The monitor checks that all participants have signed the correct and approved ICF
- Has the data been correctly entered into the study database (eCRF)? The monitor compares SD with entries made in the CRF of the study database
- Is all study staff trained and delegated to perform their study-specific tasks? The monitor checks staff training documents according to delegated and documented study responsibilities
- Have patient safety issues been handled correctly? The monitor checks documentation on implemented safety reporting procedures
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 guidelines
- 4.9 Records and reports
- 5.18 Monitoring activities
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 7.5 Clinical investigation documents and documentation
- 9.2.4 Monitoring