What is it? Why is it important?

A Clinical Study Report (CSR) / Clinical Investigation Report (CIR) is a document written by the SP-INV that describes the study by providing details on methods used and its study results.

The CSR contains sections where details regarding the DM aspects of the study are summarised, such as:

  • Quality control systems and quality assurance methods used to assure data quality (e.g. data verification, cross-checking, use of central laboratory for certain tests, data monitoring or audits)
  • Documentation of standardisation methods used (e.g. data coding, data terminology)
  • Training of study personnel regarding data entry (e.g. instruction manual)

More

The CSR is submitted within a year upon study completion, discontinuation or interruption to:

  • Swissethics through the BASEC portal
  • Swissmedic for ClinO studies with category B and C
  • Federal Office of Public Health (FOPH) for
    • Studies of therapeutic products capable of emitting ionising radiation. Only for ClinO studies with category C
    • HRO research projects involving unsealed or sealed radioactive sources
  • Study results should be reported in a clear, complete and objective manner. The report must be complete, free from ambiguity, well organised and easy to review.
  • If applicable, a longer and agreed period required for CSR submission can be defined.
  • An abbreviated CSR may be acceptable in certain cases.
  • The SP-INV should ensure that the CSR meets the standards provided by ICH E3 regarding guideline for structure and content of a clinical study reports.

What do I need to do?

With respect to the DM aspects of your study describe those measures and procedures that were implemented to ensure the quality and integrity of your study data.

As applicable, descriptions might include means by which the CDMDS system was able to handle procedure related to:

  • Data coding and anonymisation
  • Automated data processing
  • Randomisation and blinding
  • Safety reporting

The CSR is filed in the TMF of the study, with an applicable summary in the ISF at each site.

For more information refer to Documents in this Study Guide.

More

CSR submission to Swissmedic

  • Only required for category B and C studies
  • Based on ICH E3 guidelines for structure and content

Where can I get help?

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

References

  • www.swissmedic.ch
  • BASEC: submission portal to the EC.

References

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

Swiss Law

ClinO – see in particular article

  • Art. 36, 38 Specifications regarding final study report

HRO – see in particular article

  • Art. 23. Reporting of investigations involving radiation sources
Abbreviations
  • CDMS - Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • CSR – Clinical Study Report
  • CIR – Clinical Investigational Report
  • DM – Data Management
  • EC – Ethic Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Completion ↦ Data Handling ↦ Clinical Study Report ↦ Requirement
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 ↦ Data Handling ↦ Clinical Study Report ↦ Requirement

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