Set-Up↦Management↦Study Monitoring↦Site Initiation Visit
What is it? Why is it important?
During the Site Initiation Visit (SIV) the monitor prepares the site for study start. Aim of the SIV is to ensure that:
- The Site-INV and study staff are trained on
- The study protocol and the importance to comply with its specifications
- GCP, SOPs/WIs, applicable legislations and relevant study procedures
- Personal study responsibilities
- Data entry (eCRF) including access rights
- Study documents and necessary supplies for study conduct are available at the site
- A contact list with responsible staff is available to all site staff.
The SIV is part of the monitoring strategy of the study.
In the event of unresolved issues that might negatively affect participant safety or the quality of study data, study start or participant recruitment should be postponed. Unresolved issues are categorizes as:
- Minor issues: here the site can proceed with recruitment but must resolve issues within defined timeline
- Major issues: here the site must resolve the issue prior to recruitment
Major issues could be:
What do I need to do?
At the SIV, the Site-INV including applicable site staff should be present.
Main elements to review are:
- The study protocol
- Instruction on specific procedures (e.g. diagnostic tests, computer programs)
- Study SD including location
- eCRF readiness and accessibility
- Safety reporting procedures
- IMP/MD storage and handling
- Communication lines with SP-INV
- Filing of essential documents in ISF/TMF
- Documented staff trainings and delegated responsibilities
- Required SOPs including training
It is the responsibility of the SP-INV together with the monitor to plan and conduct the SIV.
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 guidelines
- 5.18 Monitoring activities
- 8 Essential documents for the conduct of a clinical trial
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 7.2 Investigator site initiation