Completion↦Quality and Risk↦Clinical Study Report↦Lessons Learned
What is it? Why is it important?
Lessons learned are insights, new knowledge and experience acquired during study conduct.
It requires that:
- Study staff members are aware of the importance of newly acquired experience and knowledge
- The SP-INV or Site-INV ensures that any new insights are appropriately documented and made available for consultation during future studies
Experiences can be both positive and negative. Either way, both types of experiences can be translated into “lessons learned”.
What do I need to do?
As a SP-INV or Site-INV, ask yourself upon study conclusion:
- Was the study risk management appropriate, given the complexity of the study?
- Which control-measures were highly effective, which ones did not adequately prevent risk occurrence?
- From a risk management perspective, how was the study able to profit considering the safety of study participants and the quality of study data ?
- How can I most effectively integrate "lessons learned" in the risk-based QMS of future studies?
The RAF is an excellent source of information regarding the established risk management and risk strategy of a completed study. This will only be possible if all risk activities were diligently documented during study development, set-up, and conduct.
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
ICH GCP E6(R2) – see in particular guideline
- 5.0 Quality management
ISO 9001 – see in particular section
- QMS Requirements (access liable to costs)