What is it? Why is it important?

A Clinical (final) Study Report is an account describing in detail the methods, events and results of a study. The reporting of the risk management of the study is an important integral part of this document.


The CSR is written after the monitoring close-out visit has taken place, as the study is then closed and ready for the statistical analysis. Among other the report describes:


The SP-INV submits the final CSR to the Ethics Committee (EC) and RA (e.g. Swissmedic), as applicable.

What do I need to do?

Based on the RAF:

  • Describe the risk-based QMS implemented in your study
  • Summarise important deviations and remedial actions taken
  • If you have been audited include the audit certificate
  • Complete other report sections and submit the report to the Ethics Committee (EC) and RA (e.g. Swissmedic), as applicable


The CSR must be ready and submitted to the EC no later than 1 year the completion (last visit of the last participant) or discontinuation of the study.

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 1.6 Audit
  • 5.0 Quality management

ISO 9001 – see in particular section

  • QMS Requirements (access liable to costs)

    Swiss Law

ClinO – see in particular article

  • Art 38 Final report


  • ClinO – Clinical Trials Ordinance
  • CSR - Clinical Study Report
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • RAF - Risk Assessment Form
  • SP-INV – Sponsor-Investigator
Completion ↦ Quality and Risk ↦ Clinical Study Report ↦ Risk Reporting

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

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
Set-Up Biobanking

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

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 ↦ Quality and Risk ↦ Clinical Study Report ↦ Risk Reporting

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