Completion↦Management↦Publishing↦Study Registries
What is it? Why is it important?
Study Registries are web-based platforms where detailed information about studies is published.
Like clinicaltrials.gov a registry has the aim to:
- Provide patients, their families, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies
Sharing scientific information is an important mean to further clinical research with the goal to provide improved treatment options to the general population.
What do I need to do?
During set-up phase and upon EC and RA approval the study was registered in:
- An international public WHO registry, and
- The federal database KOFAM (SNCTP)
Upon study completion, discontinuation or interruption, applicable updates must be made in these registries.
Registries have clear requirements regarding type of information that must be published and made available to the public (e.g. included participants, study design and methods used, results including their interpretation).
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
External Links
Swissethics - see in particular
For study registration access:
- KOFAM (SNCTP) - Swiss National Clinical Trials Portal
- ClinicalTrials.gov
- WHO – ICTRP Registry Network
- EudraCT – Clinical Trials Database
References
HRA – see in particular article
- Art. 56 Registration
ClinO - see in particular articles
- Art. 64 - 67 Registration