Set-Up↦Ethics and Laws↦Study Set-Up↦Requirements
What is it? Why is it important?
Study Set-Up requirements include:
- The registration of a study in:
- A primary registry recognised by the WHO, or in the U.S. National Library of Medicine registry (e.g. ClinicalTrials.gov)
- The federal SNCTP database (KOFAM)
- The conduct of a study initiation visit: A study monitor or another delegated person visits the study site to ensure:
- Staff is properly trained on study tasks (e.g. study protocol, safety reporting)
- Study responsibilities are clearly delegated (e.g. site delegatio-log)
- Requirements needed to start recruiting study participants are met (e.g. IMP/MD is delivered to site, informed consent procedures are in place, processes for the handing of biological material are implemented)
- A study database: Study staff is trained on data collection and how to enter data in the eCRF or pCRF
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Registering the study in an official website guarantees ongoing research transparency. This is important in order to allow other researchers and the public to gain knowledge and updates regarding current medical research.
Study registration is only possible after EC approval but must be done before study start. Exceptions are Phase I studies, that have the option to be registered for up to one year after study completion.
What do I need to do?
As a SP-INV, check that the study is ready to recruit participants, such as:
- The study is registered
- A risk-based QMS is implemented
- Site staff is properly trained
- Documentation is up to date (e.g. study initiation, TMF/ISF)
- Site contracts are signed (e.g. responsibilities are defined)
- eCRF is ready for data entry
- Processes are in place for the handling of BM
- IMP/IMD is ready for use
- Initiation visit is completed
As a Site-INV, ensure:
- The site is properly initiated by the SP-INV (e.g. IMP use, study staff is trained on study tasks regarding responsibilities, internal study processes, patient inclusion criteria and visit schedule)
- Protocol instructions on how to conduct the study are clear (e.g. intervention, safety reporting, communication)
- Document filing is up to date (e.g. ISF)
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In Switzerland, a researcher can take on the dual role of being both the SP-INV of the study and the Site-INV. In that case, both responsibilities apply. In order to avoid any conflict of interests, certain services should be hired through external service providers (e.g. study monitoring and auditing)
The SP-INV can delegate selected tasks to a CRO or CTU. However, the main responsibility remains with the SP-INV.
The Site-INV can delegate selected tasks to study staff. However, the main responsibility remains with the Site-INV.
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
References
ISO 14155:2020 Medical device (access liable to costs) – see in particular section
- 5.4 Registration in publicly accessible database
KOFAM: Coordination portal for human research – see in particular
- SNCTP for clinical trials registry
- Application & procedures
SAMS manual “Research with human subjects” – see in particular chapter
- Chapter 4 Scientific requirements / Management of conflicts of interest
Swiss Law
HRA – see in particular article
- Art. 56 Registration
ClinO – see in particular articles
- Art. 64-66 Registration
- Art. 67 Portal
ClinO-MD – see in particular article
- Art. 1 Registration