Development↦Ethics and Laws↦Ethics Application↦Approval
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
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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.
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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
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
Swiss Law
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