Completion↦Management↦Clinical Study Report↦Regulatory Requirements
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. Applicable regulatory requirements have to be followed.
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
- For submission to swissmedic 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 report
What do I need to do?
Write a CSR that describes the:
- Therapeutic, prophylactic, or diagnostic product used
- Study design and statistical methods used
- Study conduct (e.g. study visits)
- Safety issues that occurred during study conduct and if applicable follow-up
- Study outcome and their interpretation
As SP-INV of the study, forward the CSR or an applicable summary to participating Site-INV(s).
The CSR is filed in the TMF of the study, with an applicable summary in the ISF to be filed at each site.
CSR submission to Swissmedic is:
- Only required for category B and C studies
- Based on ICH E3 guidelines for structure and content
For more information refer to Documents in this Study Guide.
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
Swissethics - see in particular
- BASEC: EC submission portal
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 articles
- Art. 36, 38 Specifications regarding final study report
HRO – see in particular article
- Art. 23 Reporting of investigations involving radiation sources