Set-Up↦Monitoring↦Site Initation Visit↦Aim
What is it? Why is it important?
The Site Initiation Visit (SIV) is conducted to prepare and set up the study site for study conduct. It takes place after EC/RA (e.g. Swissmedic) approval and prior to participant recruitment.
The SIV ensures that the site is ready to enrol participants by making sure that study:
- Processes are in place (e.g. procedures for participant recruitment, data entry, safety reporting), IMP/MD handling, laboratory work)
- Staff is trained (e.g. on the study protocol, study relevant SOPs and WIs, study processes, delegated responsibilities, handling of IMP/MD, location of SD)
What do I need to do?
As a monitor conduct the SIV. Ensure both the study Site-INV and relevant site staff are present at the SIV.
Main topics to review during the SIV are:
- The study protocol
- Instructions on specific procedures (e.g. diagnostic tests, computer programmes)
- Database readiness and accessibility
- Safety reporting procedures
- Location of study SD
- IMP/MD storage and handling
- Communication lines with the SP-INV
- Filing of essential documents in the ISF and TMF
- Documented staff training and delegated responsibilities
- Required SOPs, including training
The SP-INV together with the monitor is responsible to plan and conduct the SIV.
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
- 8.1 - 4 Filing of essential documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 18.104.22.168 Initiation of the investigation site
- Annex E: Essential clinical investigation documents