What is it? Why is it important?

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)

What do I need to do?

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

Where can I get help?

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

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
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CSR – Clinical Study Report
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRO – Human Research Ordinance
  • IB – Investigator’s Brochure
  • ICH – International Council for Harmonisation
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ Clinical Study Report ↦ Procedures
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 ↦ Clinical Study Report ↦ Procedures

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