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 the Ethics Committee (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 required study processes are in place, such as:
- Procedures for participant recruitment
- Data entry requirements
- Safety assessment and reporting requirements
- The handling of the investigational therapeutic product of the study (IMP / IMD) (e.g. storage, access control, inventory or accountability processes)
- Laboratory work
- Filing of study essential documents (e.g. ISF)
- Location of Source Data (SD) providing the required study information to be entered in the study database
- Staff trainings (e.g. on study protocol, study relevant SOPs and WIs, study processes, delegated responsibilities, IMP/IMD handling)
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
- The handling of the Investigational Medicinal Product (IMP) or Investigational Medical Device (IMD) (e.g. access control, temperature control, inventory or product accountability-log)
- 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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: definition monitoring
- 3.10.1.3 Risk control
- 3.11.4 Monitoring
- 3.11.4.4 Monitoring procedures
- 3.11.4.5 Monitoring activities
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.4.4 Initiation of the investigation site
- Annex E: Essential clinical investigation documents