Your Easy Guide to Clinical Studies

A Clinical Study Report (CSR) is a document that provides a comprehensive summary of the implemented study. It is submitted to EC and Swissmedic (e.g. for risk category B and C) after the end of the study.

The CSR includes among other:

• The applied study design
• Participant recruitment (e.g. participants that completed the study, drop-outs, lost to follow-up)
• A summary of safety issues (e.g. occurrence of adverse events with recommendation for an IB update)
• Study results (e.g. statistical analysis, study endpoint reached)
• A study conclusion

The following guidelines offer templates on how to write a CSR:

• ICH E3, for studies with Investigational Medicinal Product (IMP) (ClinO)
• ISO 14155 annex D, for studies with Investigational Medical Device (IMD) (Clino-MD)

As a SP-INV:

• Irrespective of study type (e.g. studies with IMP or IMD) submit a CSR to the EC and if applicable Swissmedic:
  • Within one year after study end
  • Within 3 months, in the event the IMD study was prematurely terminated

For EC:

• Submit a CSR via BASEC
• For HRO studies, only a notification regarding the completion of the research project is required

For Swissmedic:

• Complete the notification form
• Burn the CSR on CD
• Print the study synopsis
• Send both CD and synopsis by mail

External Links

Swissethics – see in particular

• Templates and Checklists / Notifications / Template: Notification of the completion or discontinuation of the clinical trial or research project
• BASEC: EC submission portal

Swissmedic – see in particular

• Human medicines / Clinical trials / Clinical trials in medicinal product / Submission of changes during the clinical trial and reporting
• BW101_10_003e_AA Guideline Amendments and reporting in clinical trials

• References

ICH GCP E6(R2) – see in particular guidelines

• 5.22 Clinical trial / study report
• 4.13 Final report

ICH GCP E3 – see in particular guideline

• Structure and content of clinical study reports

Declaration of Helsinki – see in particular principle

• 23 Research Ethics Committees

ISO 14155:2020 Medical device (access liable to costs) – see in particular sections and annex

• 8.4 Clinical investigation report
• 8.5 Risk assessment and conclusions
• Annex D Clinical investigation report

Swiss Law

FEDLEX – laws are available online under numbers

• 810.305 ClinO
• 810.306 ClinO-MD
• 810.301 HRO

ClinO – see in particular article

• Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial

ClinO-MD – see in particular article

• Art. 37 Final report

HRO – see in particular

• Art. 22 Notification upon completion of a research project
• Art. 36 Notification requirements
• Art. 40 Notifications