Conduct↦Ethics and Laws↦Amendment↦Approval
What is it? Why is it important?
Swissmedic and EC must initially approve an amendment prior to its implementation.
Exceptions are:
- Safety amendments, where measures must be implemented with the aim to protect the safety of study participants
- Non-substantial amendments
The approval process is identical to an initial submission, such as:
- Question / answer sessions between EC/Swissmedic and SP-INV
- Comparable response timelines
- The issue of official decision letters by EC/Swissmedic
An EC/Swissmedic decision letter either states that:
- The amendment is approved and can be implemented
- The amendment can only be approved under the condition that certain required adaptations are made
- The amendment is rejected and cannot be implemented
More
Response timelines for substantial amendments include for:
- ClinO studies:
- 30 days for EC
- 30 days for Swissmedic
- 30 days for FOPH
- ClinO-MD studies:
- 30 days for EC
- 38 days for Swissmedic, which can be extended by 7 days
- HRO projects:
- 30 days for EC
What do I need to do?
As a SP-INV consider EC / Swissmedic processing timelines, and:
- Plan your amendment accordingly
- Prepare for potential question/answer sessions
Once EC/RA approved:
- Implement the amendment
- Inform concerned study sites and respective Site-INVs
- Ensure outdated documents are replaced by amended ones:
- Archive outdated documents, and ensure they are clearly identified as such (e.g. date of archiving)
- Preserve outdated electronic documents in read-only format. This guarantees that changes between documents remain traceable
- Train staff on the amendment and ensure the amendment is correctly implemented
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For Swissmedic approved studies:
- An amendment that entails a change in the SP-INV requires that a corresponding approval must be received at least 30 days prior the take-over
- Upon EC/RA approval, train study staff on documents and procedures affected by the amendment
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
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
ClinO – see in particular articles
- Art. 29 Changes IMP and other studies to EC
- Art. 34 Changes IMP studies to Swissmedic
- Art. 55-56 Changes transplant studies
ClinO-MD – see in particular articles
- Art. 15 Amendments to EC
- Art. 20 Amendments to Swissmedic
HRO – see in particular article and annex
- Art. 18 Changes
- Annex 2 EC submission