Your Easy Guide to Clinical Studies

A Clinical (final) Study Report (CSR) is a document written by the SP-INV describing study methods and study results.

 

The CSR contains sections summarising the data management aspects of the study, such as:

• Methods used to ensure data quality (e.g. quality assurance, data management plan)
• Methods used for data standardisation (e.g. data coding, variable specification)
• Training of study staff

 

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

• Swissethics through the BASEC portal
• Swissmedic. Only required for ClinO studies with risk category B or 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

 

If applicable, a longer period required for CSR submission can be defined. An abbreviated CSR may be acceptable in certain cases.

Regarding data management aspects, describe as a SP-INV those implemented procedures needed to ensure the quality of your study data. 

 

• The report should be complete, free from ambiguity, well organised and easy to review
• Study results should be reported in a clear, complete and objective manner
• Describe means by which the CDMS was able to handle procedure related to data coding and anonymisation, calculated fields, randomisation and study blinding, safety reporting
• Ensure the CSR complies with standards provided by ICH E3 regarding guideline for structure and content of a CSR
• File the CSR in the study TMF and include an applicable summary in the ISF at each study-site

References

• Swissmedic - see in particular
  • Templates/Notifications/Template for the clinical study report of clinical trial conducted under ClinO, Chapter 4
• 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