Your Easy Guide to Clinical Studies

In a laboratory, results are generated that are needed for the evaluation of the study.

 

Laboratory results can contribute:

• To answer the research question of the study (e.g. study outcome/endpoint)
• To assess the safety of study participants 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 risk-based quality management system with applicable SOPs, WIs, staff trainings, including risk-identification procedures and the implementation of risk control measures

As a SP-INV, when outsourcing analytical services to partners:

• 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
• Retain ongoing oversight during study conduct in order to ensure laboratory services remain of high quality (e.g. plan a monitoring or audit visit to the laboratory)

 

In the event of a multi-centre study, it is recommended to use a central laboratory. If this is not possible, plan on how to manage these different laboratories, and ensure results will be comparable. Laboratory maintenance and management activities must be documented to guarantee the reproducibility of study results.

 

References

EMA - see in particular

• Good laboratory practices (GLP)