What is it? Why is it important?
The Business Administration System for Ethics Committees (BASEC) is the EC portal for the submission of all clinical studies and non-clinical research projects in Switzerland:
- Clinical trials
- Research projects
- Notification of safety events
- Clarification of responsibilities
- Requests for temporary authorizations
- General questions, etc.
The submission process contains a series of screens to be filled in and documents to be uploaded.
What do I need to do?
As a SP-INV or project-leader submit your study or project (as defined under HRA) prior to implementation to EC for approval.
When planning to submit a study or research project:
- Create a personalised account
- Go through the FAQ section, which can greatly facilitate your submission
The same account can be used for multiple study submissions of different projects.
Create a dummy project via your account which allows you to find out which documents are required for your trial or research project.
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
Experienced staff at your local CTU can provide you with support on this topic
Swissethics – see in particular
- BASEC: EC submission portal
FEDLEX – law are available online under number
- 810.308 HRA
HRA – see in particular article
- Art. 56a Cantonal information system