What is it? Why is it important?
The SIV ensures that the site is ready to enrol participants by making sure that study:
What do I need to do?
The Site-INV and relevant site staff should be 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, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.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)
- 188.8.131.52 Initiation of the investigation site
- Annex E: Essential clinical investigation documents