Laboratories that process, evaluate or analyse participants’ samples for clinical research projects need to be set up and managed appropriately to ensure patient safety and data integrity are not compromised. This includes ensuring that the laboratories are working to the appropriate standard, i.e., GCP in the laboratory standard for CTIMPs and human tissue standard for clinical studies and non-CTIMPs (see also ‘Working with Human Tissue’ section above).
Attention must be paid to the whole sample pathway, ensuring that procedures are in place to maintain the laboratory facilities, manage samples appropriately whilst on their way to and once they arrive in the laboratory, and through out any storage, processing and/or analysis that takes place. Procedures also need to be in place for if things go wrong, such as equipment breakdown or loss of samples.
Further information on all the processes described above can be found in the following SOPs:
If a UoB sponsored CTIMP requires the use of a laboratory that is external to UoB, due diligence needs to be performed to ensure that this laboratory also has the processes in place to be working to the required GCP in the laboratory standard. Information on the procedure that needs to be followed and documentation that needs to be produced to evidence this can be found in the External Laboratory Set-up and Oversight SOP (UoB-CRL-SOP-006) (Word – 364 KB).