What is it? Why is it important?
In order to receive study approval the SP-INV submits an application dossier to the EC.
The dossier contains among others:
- A cover letter
- The study protocol
- The participant information and informed consent form, including any materials distributed to participants (e.g. advertisements, questionnaires)
- A list of variables to be collected or the study eCRF
- The CV of the SP-INV
- Relevant contract(s)
- Insurance certificate (HRO category A projects do not require insurance)
- The GCP certificate of the SP-INV (only for ClinO / ClinO-MD studies)
The EC may also request:
- Participant reimbursement policies
- Text for advertisement purposes
- Study SOPs
- Ionising radiation authorisations
- The monitoring plan (only ClinO / ClinO-MD studies)
- DTA / MTA for sharing biological material and/or health-related personal data
- Proof of participant death for studies with deceased persons
Some institutions might be able to support you with the compilation of the application dossier and its EC submission. Check applicable services or contact your local CTU.
What do I need to do?
Familiarise yourself with how EC processes an application dossier. The EC will:
- Only view your application dossier once all the required documents have been uploaded on BASEC
- Acknowledge the receipt of your dossier within 7 days, and 10 days for studies with Investigational Medical Devices (IMDs)
- Inform about missing or incomplete documents, including related deadlines
Once complete, the EC will process the application dossier within:
- 30 days for Investigational Medicinal Product (IMP) monocentric studies
- 45 days for IMP multicentre studies, or studies with ionising radiation
- 40 days for IMD studies
- 60 days for studies with gene therapy, GMO, pathogenic organisms, and studies involving ionising radiation
EC can request additional information from the SP-INV / Site-INV. This extends the processing timeline as the clock is stopped until all required information is received.
For ClinO-MD studies, the deadline to submit additionally requested information is 10 days. If the deadline is not met, the application will not be admitted.
You can start your study once EC approval is received. In some instances a Swissmedic / FOPH approval is also required. For these studies, both approvals must be obtained before starting the study.
If you plan to share biological material and/or any associated data with other researchers, include in your application dossier a:
- Material Transfer Agreement (MTA)
- Data Transfer Agreement (DTA)
These agreements define conditions and respective responsibilities regarding the sharing and use of biological material and its associated data.
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
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
ClinO – see in particular annex
- Annex 3 Submission document list
ClinO-MD – see in particular annex
- Annex 1 Submission document list
HRO – see in particular annex
- Annex 2 Submission document list