Completion↦Management↦Publishing↦Study Registries
What is it? Why is it important?
Study Registries are web-based platforms where detailed information on ongoing and completed studies are published.
Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive. As a minimum, study results should be published in a registry recognized by the World Health Organization (WHO), such as the ClinicalTrials.gov registry,
A study registry has many advantages as it:
- Functions as a public record where study results are presented in a standardized format
- Complies with required ethical obligations towards study participants
- Ensures that research results contribute to overall medical knowledge
- Reduced publication and outcome reporting biases
- Facilitates systematic reviews and other research literature reviews
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?
As a SP-INV:
- Update all registries that were previously selected during study set-up, irrespective whether the study was completed as planned, discontinued, or interrupted
- Ensure that for all publications, measures are taken to maintain the confidentiality of study participants
Registries have clear requirements regarding type of information that must be published (e.g. recruited participants, study design and methods, results, the discussion and interpretation of results).
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
- RAPS Registry, a database of all projects approved by the ethics committees in Switzerland
Swiss and international registries:
- KOFAM (SNCTP) - Swiss National Clinical Trials Portal
- ClinicalTrials.gov
- WHO – ICTRP Registry Network
- EudraCT – Clinical Trials Database
References
Declaration of Helsinki – see in particular principle
- 36 Registration and Publication and Dissemination of results
SAMS Research with human subjects – see in particular chapter
- Chapter 11 Publication of study results
CIOMS guideline – see in particular
- 24 Public accountability for health-related research
Swiss Law
HRA – see in particular article
- Art. 56 Registration
ClinO – see in particular articles
- Art. 64 - 67 Registration
ClinO-MD – see in particular articles
- Art. 41 Registration