What is it? Why is it important?

A Clinical Study Report (CSR) is a document that provides a comprehensive summary of the implemented study.

 

The CSR includes among others:

  • 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. safety assessment with the occurrence of adverse events, recommendation for an IB update)
  • Study results (e.g. study endpoint reached)
  • Study conclusion

 

The CSR is submitted within a year upon study completion to:

 

 

 

More

For the discontinuation or interruption of a clinical trial with IMP (ClinO), the EC must be informed within 15 days.

What do I need to do?

As a SP-INV write the study CSR and ensure that:

  • The report is complete, well organised, free from ambiguity, and easy to review
  • Study results are complete, clear, and written in an objective manner
  • Swissmedic submission complies with ICH E3 standards (e.g. guidelines for the structure and content of a CSR)
  • The CSR or a summary is forwarded to potential participating study sites (e.g. to be filed in the ISF)
  • The CSR is filed in the TMF

 

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

  • ICH E3, for IMP ClinO studies
  • ISO 14155 annex D, for IMD ClinO-MD studies

 

As a project leader of an HRO project, notify the EC within 90 days regarding the completion, discontinuation of a research project.

 

More

If required, a longer CSR submission timeline can be requested. In some cases, an abbreviated CSR may be acceptable. Contact authorities for clarification.

Where can I get help?

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

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

Declaration of Helsinki – see in particular principle

  • 23 Research Ethics Committees

ICH E3 – in particular see guidelines for submission to Swissmedic

  • Section 1-15 Structure and Content of Clinical Study Reports

ICH GCP E6(R2) – see in particular guidelines

  • 1.13 Definition clinical study report
  • 4.13 Final report by investigator
  • 5.22 Clinical study report

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 8.4 Clinical investigation report
  • Annex D Clinical investigation report

Swiss Law

ClinO – see in particular articles

  • Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
  • Ar. 44 Notification on the use of radiation sources

ClinO-MD - see in particular

  • Art. 37 Final report

HRO – see in particular article

  • Art. 22 Notification upon completion of a research project
  • Art. 23 Reporting of investigations involving radiation sources
  • 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
  • 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
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Completion ↦ Management ↦ Clinical Study Report ↦ Requirement
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Management ↦ Clinical Study Report ↦ Requirement

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