Set-Up↦Monitoring↦Site Initation Visit↦Prerequisite
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.
- All studies must have EC approval
- Swissmedic approval is required for
- ClinO IMP studies with risk category B and C
- ClinO-MD IMD studies with risk category C
- 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
When submitting documents to the EC/RA, the Site-INV signs the final study protocol and thereby confirms that he or she has read and understood its content, and agrees to comply with the protocol when conducting the study.
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
- 8.1 - 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
ClinO – see in particular article
- Art. 5 Good Clinical Practice
- Art. 19 - 20 Study categorisation
HRO – see in particular article
- Art. 7 Research categorisation