Your Easy Guide to Clinical Studies

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 done:
  • 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 done:
  • Immediately after submitting the clinical (final) study report to Ethics Committee (EC) (e.g. also applies if the study is terminated or interrupted)

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.

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

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