Completion↦Ethics and Laws↦Clinical Study Report↦Procedures
What is it? Why is it important?
A Clinical Study Report (CSR) is a document that provides a comprehensive summary of the implemented study. It is submitted to EC and Swissmedic (e.g. for risk category B and C) after the end of the study.
The CSR includes among other:
- 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. occurrence of adverse events with recommendation for an IB update)
- Study results (e.g. statistical analysis, study endpoint reached)
- A study conclusion
The following guidelines offer templates on how to write a CSR:
- ICH E3, for studies with Investigational Medicinal Product (IMP) (ClinO)
- ISO 14155 annex D, for studies with Investigational Medical Device (IMD) (Clino-MD)
What do I need to do?
As a SP-INV:
- Irrespective of study type (e.g. studies with IMP or IMD) submit a CSR to the EC and if applicable Swissmedic:
- Within one year after study end
- Within 3 months, in the event the IMD study was prematurely terminated
For EC:
- Submit a CSR via BASEC
- For HRO studies, only a notification regarding the completion of the research project is required
For Swissmedic:
- Complete the notification form
- Burn the CSR on CD
- Print the study synopsis
- Send both CD and synopsis by mail
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
ICH GCP E6(R2) – see in particular guidelines
- 5.22 Clinical trial / study report
- 4.13 Final report
ICH GCP E3 – see in particular guideline
- Structure and content of clinical study reports
Declaration of Helsinki – see in particular principle
- 23 Research Ethics Committees
ISO 14155:2020 Medical device (access liable to costs) – see in particular sections and annex
- 8.4 Clinical investigation report
- 8.5 Risk assessment and conclusions
- Annex D Clinical investigation report
Swiss Law
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
ClinO – see in particular article
- Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
ClinO-MD – see in particular article
- Art. 37 Final report
HRO – see in particular
- Art. 22 Notification upon completion of a research project
- Art. 36 Notification requirements
- Art. 40 Notifications