Completion↦Data Handling↦Clinical Study Report↦Requirement
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)
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.
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
- BASEC: submission portal to the EC.
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
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