Your Easy Guide to Clinical Studies

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
• Study population and participant recruitment (e.g. participants that completed the study, drop-outs, lost to follow-up)
• Quality by Design aspects such as the Critical-to-Quality factors of the study
• A summary of safety issues (e.g. safety assessment with the occurrence of adverse events, recommendation for an IB update)
• Study analysis and reporting (e.g. study outcome/endpoint reached)
• Study interpretation and conclusion

 

The CSR is submitted within a year upon study completion (unless a longer period is specified in the protocol) to:

• The Ethics Committee (EC) through BASEC (e.g. EC submission portal)
• Swissmedic (e.g. Swissmedic submission portal) for studies with an investigational:
  • Medicinal Product (IMP) (e.g. ClinO; risk-category B and C)
  • Medical Device (IMD) (e.g. ClinO-MD; risk-category C). Prematurely terminated IMD studies must be submitted within 3 months
• Federal Office of Public Health (FOPH) for studies with the use of radiation sources

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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 study sites that participated in the study (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

 

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

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(R3) – see in particular guidelines

• Glossary: Definition clinical trial / study report
• 3.17.2 Clinical trial / study reports
• 2.13 Reports

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
• Art. 44 Notification on the use of radiation sources

ClinO-MD - see in particular

• Art. 37 Final report

HRO – see in particular articles

• Art. 22 Notification upon completion of a research project
• Art. 23 Reporting of investigations involving radiation sources