Your Easy Guide to Clinical Studies

Lessons learned are important experiences and observations gathered during study planning and conduct.

 

These lessons could be useful to improve the management of subsequent studies. The aim would be to repeat experiences that were fruitful, and avoid those experiences that were problematic.

 

Thus, already during study planning and conduct, but certainly upon study termination, a retrospective evaluation of the study should be performed. Experiences both positive and negative gathered during earlier studies could greatly benefit the successful implementation of future studies.

As a SP-INV, , assess lessons learned regarding the:

Budget:

• What factors resulted in a deviation from the original budget plan?
• What aspects were forgotten (e.g. archiving-, publication-, inspection costs)?

Participant recruitment:

• Were adequate eligible participants available?
• Were timelines and processes respected?

Resources and processes:

• Was study staff sufficiently qualified? Were study responsibilities clearly communicated? Was there adequate time at disposal?
• Was infrastructure satisfactory?
• Did study SOPs, WIs, processes, including the quality of essential documents support study planning and conduct? Alternatively, could some be skipped as they did not result in substantial improvement?
• Was the monitoring of the study adequate and resulted in an increase in data quality and participant safety?
• Did Data Management processes ensure the quality of study data?

Biobanking

• Were processes needed for the handling of biological material adequate to guarantee quality

Study oversight

• Was the division of tasks and responsibilities clear? What strategies were helpful, which ones just added extra unnecessary workload?