What is it? Why is it important?
A final study report is an account describing in detail the methods, events and results of a study. The reporting of the risk management of the study is an important integral part of this document.
Part of the report describes the QMS implemented during the study:
- Identified and categorised study risks including applicable control measures
- Important deviations and remedial actions taken
What do I need to do?
Based on the RAT:
- Describe the risk-based QMS implemented in your study
- Summarise important deviations and remedial actions taken
- If you have been audited include the audit certificates
- Complete other report sections and submit the report to the EC and RA as applicable
The final study report must be submitted to the EC within 1 year after completion (last visit of the last participant) or discontinuation of the study.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 1.6 Audit
- 5.0 Quality management
ISO 9001 – see in particular section
- QMS Requirements (access liable to costs)
ClinO – see in particular article
- Art 38 Final report