Completion↦Management↦Clinical Study Report↦Requirement
What is it? Why is it important?
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
- Participant recruitment (e.g. participants that completed the study, drop-outs, lost to follow-up)
- A summary of safety issues (e.g. safety assessment with the occurrence of adverse events (Medicinal Product, Medical Device), recommendation for an IB update)
- Study results or the answer to the research question (e.g. study outcome / endpoint reached)
- Study conclusion
The CSR is submitted within a year upon study completion 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
More
- For the discontinuation or interruption of a clinical trial with IMP (ClinO), the EC must be informed within 15 days.
- For HRO projects the EC is notified within 90 days regarding the completion or discontinuation of a research project.
What do I need to do?
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 potential participating study sites (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
If required, a longer CSR submission timeline can be requested. In some cases, an abbreviated CSR may be acceptable. Contact authorities for clarification.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
Swissethics – see in particular
- Template for the clinical study report of clinical trial conducted under ClinO chapter 4
Swissmedic – see in particular
- BW101_10_003_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
- Structure and content of clinical study reports
ICH GCP E6(R3) – see in particular guidelines
- Glossary: Definition: Clinical Trial/Study Report (CSR)
- 2.13 Reports (Site-INV)
- 3. 17 Reports (SP-INV)
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
- Ar. 44 Notification on the use of radiation sources
ClinO-MD - see in particular
- Art. 37 Final report
- Art. 39 Reporting in relation to the use of ionising radiation
HRO – see in particular article
- Art. 22 Notification upon completion of a research project
- Art. 23 Reporting of investigations involving radiation sources
- Art. 36 Notification requirements
- Art. 40 Notifications