What is it? Why is it important?

The SP-INV has the obligation to update all registries, where the study was initially registered.

Upon study completion, the SP-INV updates registries by documenting:

  • The date of study closure (e.g. last patient last visit)
  • Study recruitment status (e.g. number of study participants, participant withdrawals and lost to follow-up)
  • If applicable, justification for early termination
  • Study results (e.g. statistical analysis)
  • References to any published articles

For Medical Device (ClinO-MD) studies, timelines for registry updates are defined:

  • For risk-category C studies registry update must be:
    • Before the device is placed on the market
    • If the device is not yet placed on the market, at the latest one year after submitting the clinical (final) study report
  • For risk-category A studies registry updates must be:
    • Immediately after submitting the clinical (final) study report to EC (e.g. also applies if the study is terminated or interrupted)

What do I need to do?

As a SP-INV:

  • Access all registries that were used to register your study at study start
  • Update your study data according to respective registry guidelines, such as:
    • Date of study closure (e.g. for multi-centre studies only after all participating study sites are closed)
    • Justification for study termination, and if applicable study discontinuation or interruption
    • Information on participant recruitment
    • An overview and conclusion of your study results
    • References to any published articles

For medical device studies, publish your study results in a respective recognised registry.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

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 4.2 Scientific quality

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 Swiss portal

ClinO-MD – see in particular articles

  • Art. 1 Subject matter
  • Art. 49 Transitional provisions
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • SAMS – Swiss Academy of Medical Sciences
  • SNCTP – Swiss National Clinical Trials Portal
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Registry Update
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): Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Registry Update

Please note: the Easy-GCS tool is currently under construction.