What is it? Why is it important?
Lessons learned are insights, new knowledge and experience acquired during study conduct.
It requires that:
- Members are aware of the importance of newly acquired knowledge
- New insights are appropriately documented
Experiences can be both positive and negative. How these experiences are handled translates into “lessons learned”.
What do I need to do?
As a review for future studies, ask yourself:
- Was the risk management appropriate for the study?
- Which control-measures were most effective?
- How did the study profit from a risk management perspective?
- Which risk management activities should be repeated, which one avoided?
- What aspects of lessons learned can contribute to an improved future risk based QMS?
By completing the RAT during study set-up and conduct will provide a good summary of defined study risks including mitigating strategies.
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 guideline
- 5.0 Quality management
ISO 9001 – see in particular section
- QMS Requirements (access liable to costs)
- Risk Assessment Tool (RAT) – Template: A tool to assess study risks