Completion↦Management↦Study Closure↦Notification of Closure
What is it? Why is it important?
Depending on study type, closing the study requires that respective institutions are notified.
For ClinO studies, the SP-INV notifies:
- The EC over BASEC of any study:
- Completion within 90 days
- Discontinuation or interruption within 15 days. Include reasons for study closure
- Swissmedic for category B and C studies. Timelines are identical to the EC timelines.
For HRO projects, the project leader notifies:
- The EC of study completion or discontinuation within 90 days
Notification to Swiss authorities is only applicable to studies implemented in Switzerland.
What do I need to do?
Notify applicable authorities regarding study completion, discontinuation or interruption.
File any confirmation received by EC and RA in the trial master file (TMF) and the investigator site file (ISF) of the study. Also Inform participating study sites of study closure.
For more information refer to Ethics and Laws in this Study Guide.
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 template of the completion or discontinuation of a clinical study or research project
- BASEC: EC submission portal
ClinO – see in particular article
- Art. 38 Notification upon completion, discontinuation, or interruption of a study
HRO – see in particular article
- Art. 22, 36, 40, 43 Specifications regarding notification upon completion or discontinuation of a research project