What is it? Why is it important?
Amendments are changes to an existing study protocol.
Amendments can either be:
- Substantial (SA): with expected implications to the scope of the study (e.g. participant safety, responsibilities)
- Non-substantial (N-SA): with no expected implications to the study scope ( more administrative / formal changes)
With the exception of safety amendments, SAs require approval before implementation. They must therefore be submitted and approved by EC and if applicable by Swissmedic.
Non-substantial amendments do not require initial approval before implementation, but are submitted to:
- Swissmedic as soon as possible
- The EC in the annual safety report
Safety amendments require special handling, as protective measures must be implemented prior to approval, in order to protect study participants. The EC and Swissmedic are notified as soon as possible.
What do I need to do?
As a SP-INV and Site-INV:
- Immediately, or as soon as possible, implement, in the event of a safety amendment, required protective measures
As a SP-INV:
- Check the Swissmedic and EC homepage in order to determine whether a planned amendment is a SA or N-SA
- Define reason(s) why you think an amendment is necessary
- Familiarise yourself with the required submission procedures
Examples of substantial amendments:
- Changes needed to protect the safety and rights of study participants (safety amendment)
- New scientific evidence becomes available requiring adaptations in study aim, safety concerns, statistical study plan
- The required addition of additional study sites (multi-centre study)
- Replacement of the Site-INV requiring a shift in site responsibilities
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Substantial amendment: YES or NO or "it depends"
Swissmedic – see in particular
- BW101_10_003e_AA Guideline Amendments and reporting in clinical trials
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
ClinO – see in particular article
- Art. 29 Changes
ClinO-MD – see in particular articles
- Art. 15 Amendments to EC
- Art. 20 Amendments to Swissmedic
HRO – see in particular article
- Art. 18 Changes