What is it? Why is it important?
The online portal BASEC is the Business Administration System of the Swiss Ethics Committee (e.g. EC-portal).
BASEC is used by researchers to submit documents needed for the approval of clinical studies (e.g. ClinO, ClinO-MD), and non-clinical research project (e.g. HRO projects) based in Switzerland.
The EC-portal is also used by researchers to submit:
- Amendments during study conduct
- Notification of safety events
- Submission of an annual safety reports
- Notification of study completion or discontinuation
- General study relevant questions
In BASEC researchers:
- Set-up a personal account using a personal login
- Fill in EC requested study information
- Upload applicable study documents needed for EC approval
What do I need to do?
As a SP-INV or project leader seeking EC approval:
- Create a BASEC account with a personal login.
- Go through the FAQ section, which will greatly facilitate the submission process
- As applicable, start by establishing a dummy study or project, which helps you to find out which documents to submit (e.g. the same account can be used for multiple submissions)
- Fill-in all requested study information
- Upload all study or project required documents
A study or research project can only start after EC has given its approval. Based on study type and risk-category, approval must also be provided by Swissmedic and the FOPH.
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
Experienced staff at your local CTU can provide you with support on this topic
Swissethics – see in particular
- BASEC: EC submission portal
HRA – see in particular article
- Art. 56a Cantonal information system