What is it? Why is it important?

Once the EC has assessed the application dossier:

  • The study is provided with a unique ID (e.g. consists of a BASEC identification number and/or an EC reference number)
  • An order is issued conveying its decision. In general, the decision states that study conduct is:
    • Granted: The study can start
    • Granted with conditions Changes or adaptations must be fulfilled within 30 days
    • Not granted: If resubmitted, the EC will consider the dossier as a new submission (e.g. the original BASEC ID is retained)

The EC order also includes:

  • Additional information regarding pending tasks
  • A summary of submitted documents. EC approval only applies to those documents that were submitted in the application dossier

More

The EC might also forward a list of outstanding questions to the SP-INV, which includes:

  • An order stating the decision of the EC
  • A list of pending questions
  • A separate document where any relevant questions & answers are entered (Word table)

What do I need to do?

In the event, approval was granted based on conditions:

  • Ensure to correctly answer all EC question(s)
  • If applicable, provide additional documents or make requested adaptations
  • Report back within the deadline (30 days)

Once the study has been fully approved, the SP-INV must ensure that:

  • The EC-identifier-number is included during any correspondence with EC
  • A robust document tracking system is in place, to ensure that only EC approved documents are used in the study
  • Any changes to EC approved documents are re-submitted for EC approval prior to implementation

Some studies also require Swissmedic / FOPH approval. Consequently, wait for all required approvals before starting the study.

More

In the event the EC requires you to answer some questions:

  • Write a cover letter
  • Complete the question & answer table
  • Make required changes or adaptations to relevant study documents (e.g. both in track-changes and clean version)
  • Create and include any additionally requested documents
  • Access BASEC to submit your updated application dossier

File all correspondence with EC, including the order of approval in the TMF, and if applicable in the local ISF.

Where can I get help?

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

HRA – see in particular articles

  • Art. 32 Further use of biological material and data
  • Art. 33 Further use of non-genetic HRpD
  • Art. 34 Absence of IC
  • Art. 36 Consent
  • Art. 37 Requirements for deceased persons
  • Art. 39-40 Requirements for embryos and foetuses
  • Art. 47 Responsible EC

ClinO – see in particular articles

  • Art. 23 Coordination in authorisation procedures
  • Art. 25 Review areas
  • Art. 26 Procedures and deadlines

ClinO-MD – see in particular articles

  • Art. 9 Information and coordination for approval procedures
  • Art. 11 Review areas
  • Art. 12 Procedures and deadlines

HRO – see in particular articles

  • Art.15 Review areas
  • Art. 16 Procedure and deadlines
  • Art. 34 Review areas for project involving further use of data or biological material
  • Art. 37 Review areas for project involving further use of data or biological material in the absence of IC
  • Art. 41 Review areas for project involving deceased persons
  • Art. 45 Review areas for project involving embryos and foetuses
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • IC – Informed Consent
  • ISF – Investigator Site File
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health Related Personal Data
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Development ↦ Ethics and Laws ↦ Ethics Application ↦ Approva
Study
Basic

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

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
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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
Completion

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): Development ↦ Ethics and Laws ↦ Ethics Application ↦ Approva

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