Set-Up↦Monitoring↦Site Initation Visit↦Preparation
What is it? Why is it important?
The Site Initiation Visit (SIV) should be well prepared because it provides an important opportunity to train staff on study tasks and responsibilities.
In most cases, the SIV is performed by the monitor(s) who presents the planned monitoring procedures; while the SP-INV presents the study protocol.
The SP-INV can appoint other personnel to perform the SIV. However, the SP-INV must ensure that those performing the SIV are well-qualified and properly trained to perform this task.
What do I need to do?
As a SP-INV ensure that the monitor performs his or her tasks according to the monitoring plan.
If you are the study monitor, prepare the site for an upcoming SIV:
- Arrange a date for the SIV visit with the site and invite relevant staff
- Prepare an agenda with topics to discuss, including what processes and tasks to train
- Complete pre-study TMF and ISF filing. The ISF is handed over to the site at the SIV
- Ensure that IMP/MD is available at the study site and ready to use
- Confirm access to the study database needed for staff training
- Decide on who will be responsible for any staff training
- Prepare relevant study logs, such as the delegation log and a SIV training log
- Prepare a SD location list. In a multicentre study prepare an applicable list for each participating site
Prepare an easy-to-follow and relevant study presentation:
- Include diagrams or flow-charts. A clever designed image can replace highly complicated written procedures (e.g. the study design, safety reporting, analytical processes)
- A physician / Site-INV can present and explain more complicated medical issues
- Make sure that the infrastructure needed for your presentation and training sessions is available at the site (e.g. a beamer, flip chart, video transmission, magnet board, material needed illustrate points)
In order to guarantee effective communication and training, use a local or common language. If needed, organise an interpreter who can participate at 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
- swissethics – Information on safety reporting
- swissmedic – Information on safety reporting
ICH GCP E6(R2) – see in particular guidelines
- 4.11 Safety reporting
- 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
- 10.8 Safety Reporting
- Annex E: Essential clinical investigation documents
ClinO – see in particular article
- Art. 37 – 43 Safety Reporting
HRO – see in particular article
- Art. 20 – 20 Safety notification