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, emergency- and improvement plan
What do I need to do?
When outsourcing analytical services to partners:
- Define type of analysis required
- Select a laboratory based on required experience, including applicable accreditations with respect to provided services
- Request accreditation certificates
- In multi-centre studies 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
- Define responsibilities in a joint contract, including potential publication rights
Laboratory maintenance and management activities must be documented in order to guarantee reproducibility of results.
To obtain comparable results in a multi-centre study a central laboratory is recommended.
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)