What is it? Why is it important?
- Substantial, or
- Non-substantial, or
- Safety amendments (always considered a substantial amendment)
Substantial amendments require prior EC/RA approval. Exception are safety amendments where protective measures are immediately implemented (e.g. or as soon as possible) in order to protect study participants.
What do I need to do?
As a SP-INV and based on problems or situations encountered during study conduct:
- Decide whether an amendment is necessary
- Apart from the protocol, identify documents that must be adapted as they become affected by the amendment (e.g. PIS/ ICF, CRF, etc.)
- Prepare the amended documents and submit the request for an amendment to the EC and if applicable RA (e.g. Swissmedic)
Prepare the amended documents as follows:
- Create the amended documents in a clean and track-change version
- Adapt the document identification accordingly (e.g. date, version)
- Summarize changes in the cover letter
- Submit the amendment to EC, and if applicable RA, for approval
The amendment can only be implemented in the study after EC/RA approval has been received
For more information refer to Protocol in this Study Guide.
Except for safety amendments, carefully evaluate whether a substantial amendment is necessary. Note that preparing and submitting an amendment dossier to EC/RA, as well as implementing the amendment will require additional resources (e.g. staff, finances). An amendment might both increase the cost and the duration of the study.
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
Swissethics – see in particular
- Notification of significant and other changes to the EC
ICH GCP E6(R2) – see in particular guidelines
- 1.44 Protocol definition
- 1.45 Protocol Amendment definition
- 4.5 Compliance with Protocol
- 6 Clinical Trial Protocol and Protocol Amendment(s)
ISO 14155:2020 Medical devices – see in particular sections (access liable to cost)
- 6.4 Clinical investigational plan (CIP)
- 7.5.1 Amendments
- 10.5 Informed consent procedure
- 10.6 Compliance with CIP
- Annex A Clinical investigational plan
ClinO – see in particular articles
- Art. 29, 34, 55 Changes
HRO – see in particular article
- Art. 18 Changes