Completion↦Ethics and Laws↦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, recommendation for an IB update)
- Study results (e.g. study 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.
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
As a project leader of an HRO project, notify the EC within 90 days regarding the completion, discontinuation of a research project.
More
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 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
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(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
- 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
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