Your Easy Guide to Clinical Studies

“Lessons Learned” are insights, new knowledge and experience acquired during study planning, set-up, conduct, and completion

 

It requires that:

• Study staff members are aware of the critical importance of capturing, and applying, newly acquired experience and knowledge throughout the study lifecycle
• The SP-INV or Site-INV ensure that any new insights are appropriately documented (e.g. in the study`s Risk-Assessment-Form (RAF) established during study planning and updated during study conduct until completion)
• The SP-INV implements an overall assessment of collected “Lessons Learned”, and establishes a process that ensures experiences are reviewed and:
  • Integrated in the planning of future studies (e.g. development of quality processes, establishment of a risk-based Quality Management System (QMS))
  • Used to support a “Quality by Design” (QbyD) approach when planning future studies

 

Experiences can both be positive and negative. Either way, both types of experiences can be translated into a “Lesson Learned”.

As a SP-INV or Site-INV, upon study conclusion:

• Ask yourself, which “Lessons Learned” turned out to be especially valuable in supporting the quality of the study?
• Ask yourself, which “Lessons Learned” turned out to be especially valuable in protecting the integrity of the studies “Critical to Quality” (CtoQ) factors?
• Provide a summary of valuable “Lessons Learned” with the aim to support a QbyD approach in future studies. Ensure a process is in place to ensure “Lessons Learned” are incorporated during the planning process.
• Based on “Lessons Learned” establish quality processes (e.g. SOPs, Wis) that avoid the re-occurrence of previously unwanted effects or consequences during study conduct (e.g. risks to participant right and safety and/or data quality)

 

The study`s RAF is an excellent source used to review, document, and establish quality processes based on “Lessons Learned”. This is only possible if “Lessons Learned” were diligently documented during previous studies.

References

ICH GCP E6(R3) – see in particular guideline

• 3.10 Quality management

ICH E8(R1) – see in particular

• 3.1 Quality by Design of clinical studies
• 3.2 Critical to Quality Factors

ISO 9001 (access liable to costs) – see in particular section

• QMS Requirements

Documents

• Risk Assessment Form for Clinical Research Projects