Your Easy Guide to Clinical Studies

The SP-INV of a study is required to update all those registries where the study was initially registered. Studies in online registries are made available to researchers and the general public, which ensures ongoing research transparency.

 

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

HumRes: Coordination portal for human research in Switzerland

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. 48 Transitional provisions