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
    • 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 delegation log)
    • Requirements needed to start recruiting study participants are met (e.g. IMP/MD is delivered to site, 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

More

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. 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)

More

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

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

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD

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
Abbreviations
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • KOFAM – Coordination portal for human research
  • pCRF – paper Case Report Form
  • QMS – Quality Management System
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SNCTP – Swiss National Clinical Trial Portal
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
  • U.S. – United States
  • WHO – World Health Organization
Set-Up ↦ Ethics and Laws ↦ Study Set-Up ↦ Requirements
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Set-Up ↦ Ethics and Laws ↦ Study Set-Up ↦ Requirements

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