What is it? Why is it important?
The study is ready to be initiated after the following criteria are met:
- The study IMP is ready for implementation
- EC approval has been received
- If required, RA (e.g. Swissmedic and/or FOPH) approval has been received
- The study database (eCRF) is ready for data entry
- Study IMP/IMD and materials are available at the site or ready for delivery
- The Site-INV is trained in GCP, including additional study staff as required.
The SP-INV confers with the study site to decide when the study site is ready to be initiated.
The SP-INV is responsible to appoint a monitor who is trained, has the appropriate scientific knowledge, and is thoroughly familiar with the study protocol and relevant study interventions
What do I need to do?
As a monitor ensure that the following documents and tasks have been completed before the SIV takes place:
- EC/RA (e.g. Swissmedic) approvals, including relevant correspondence between SP-INV and Site-INV, are filed in the TMF and ISF
- The testing phase of the study database (validation & approval) is complete, and ready for productive phase with data entry
- IMP/MD and material has been ordered and is ready to be delivered to the study site
- IMP has been labelled with approved study stickers
- Study staff is qualified and trained in GCP
It is a great advantage, if prior to the SIV study staff has familiarised themselves with the study protocol
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
- swissethics – Information on education and training
ICH GCP E6(R2) – see in particular guidelines
- 4.5 Protocol compliance
- 5.18 Monitoring activities
- 8. Essential documents for the conduct of a clinical trial
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
ClinO – see in particular article
- Art. 5 Good Clinical Practice
- Art. 19 - 20 Study categorisation