What is it? Why is it important?

The study SP-INV or a Site-INV can ask the Ethics Committee (EC) to clarify questions or issues related to study planning and conduct.

The EC can provide support:

  • By deciding whether a planned research project falls under the HRA act or not. The EC can issue a written statement confirming that the project does not need EC approval
  • By assigning the risk category to a study
  • Concerning administrative tasks, such as required documents to be submitted for study approval
  • Regarding ethical questions and issues relevant to study planning and conduct

What do I need to do?

As a SP-INV and Site-INV:

  • Access the swissethics webpage
  • Log into BASEC, if applicable create an account
  • Click on “Submit an application”
  • Go to “Clarification of Responsibility / Support Request”
  • Fill in the form
  • Submit your application

As an alternative, each of the seven local ECs have secretarial offices that can be contacted by phone. They will be able to either answer your questions or advice you on how to proceed.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • BASEC: the portal for EC submission
  • BASEC – Business Administration System for Ethics Committees
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Regulatory Advice Meeting ↦ Ethics Clarification

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Set-Up Biobanking

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Regulatory Advice Meeting ↦ Ethics Clarification

Please note: the Easy-GCS tool is currently under construction.