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 (e.g. ClinO Studies), ISO 14155 (ClinO-MD studies),
- Study relevant procedures documented in SOPs/WIs
- Applicable legislations and regulatory requirements (e.g. Swiss law)
- Study delegated responsibilities (e.g. site delegation-log)
- Data entry (eCRF) procedures including access rights
- Study documents, necessary supplies, instruction manuals needed for study conduct are available at the site (e.g. IMP/IMD handling and storage, filing of essential documents in TMF/ISF)
- 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 a defined timeline
- Major issues: here the site must resolve the issue prior to participant recruitment
Major issues could be:
What do I need to do?
As a Site-INV, ensure all applicable site staff is present at the SIV. Main elements to review include:
- The study protocol
- Instruction on specific procedures (e.g. diagnostic tests, computer programs)
- Study SD including its location (e.g. patient file, laboratory test results)
- eCRF readiness and accessibility
- Safety reporting procedures
- IMP/IMD storage and handling, including applicable instruction manuals
- Communication lines with SP-INV
- Filing of essential documents in ISF/TMF
- Documented staff trainings and delegated responsibilities (e.g. site delegation- and training-logs)
- The training of study relevant SOPs, WIs, processes (e.g. ICF process)
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