Your Easy Guide to Clinical Studies

Lessons learned are important experiences that should be kept in order to improve the management of subsequent studies.

Thus, upon study termination a retrospective evaluation of the study conduct should be performed in order to repeat experiences that were fruitful and avoid those that were not.

With a critical assessment of the lessons learned. Experiences both positive and negative gathered during earlier studies can greatly benefit the successful planning and conduct of future studies

Aspects to assess upon study closure are:

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?
• Was timeline and processes respected?

Resources and processes:

• Was study staff sufficiently qualified for study responsibilities? Was there adequate time at disposal?
• Was infrastructure satisfactory?
• Did study SOPs, WIs, processes, including various study documents support study planning and conduct?
• Were processes or documents implemented, which could have been skipped as those did not result in substantial improvement?
• Was the monitoring adequate and resulted in increased data quality and patient protection?
• Were Data Management processes adequate?