What is it? Why is it important?
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
What do I need to do?
Aspects to assess upon study closure are:
- What factors resulted in a deviation from the original budget plan?
- What aspects were forgotten (e.g. archiving-, publication-, inspection costs)?
- 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?
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