What is it? Why is it important?
In a laboratory, results are generated that are needed for the evaluation of the study.
Laboratory results can contribute:
- To answer the primary (secondary) question(s) of the study
- To evaluate participants safety during study conduct (e.g. threshold values for decision regarding study continuation)
Running a laboratory requires:
- Professionally trained staff and leadership
- Ongoing maintenance of analytical equipment (e.g. centrifuge, haematology-, chemistry analysers, freezers)
- A quality management system with applicable SOPs, WIs, staff trainings, risk management (e.g. risk-based approach), emergency- and improvement plan (e.g. emergency plan)
What do I need to do?
- Define type of analysis required
- Select a laboratory based on required experience, including applicable accreditations with respect to the requested service(s)
- Request accreditation certificates
- Define responsibilities in a joint contract, including potential publication rights
In the event of a multi-centre study, it is recommended to use a central laboratory. If this is not possible, make a plan on how to manage these different laboratories, and ensure results will be comparable. Laboratory maintenance and management activities must be documented in order to guarantee reproducibility of results.
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
EMA - see in particular
- Good laboratory practices (GLP)