If you are working with human tissue samples which contributes to the (primary, secondary and exploratory) endpoints of a clinical trial, you are required to work to GCP in the Laboratory standard. This includes Clinical Trials of Investigational Medicinal Products (CTIMPs) and non-CTIMPs.
If you are working with human tissue that is considered relevant material under the Human Tissue Act, and is part of a clinical study, you are required to work to the Human Tissue standard.
For further information on what it means to be working to either of these standards please see the Laboratory and Human Tissue section of the UoB Clinical Research QMS.
The CRCT deliver a training session several times a year focussing on these laboratory standards. One of the training sessions is called ‘Clinical Research in a UoB Laboratory’, which focusses on both GCP in the Laboratory and Human Tissue standards. Another training session called ‘Working with Human Biomaterial in a UoB laboratory’ focusses solely on the Human Tissue standard. To see when our next training session will be and to register please visit our Training and Workshop page.
If you are aware that you need to work to GCP in the Laboratory standard and require support with the set up process please contact us
to find out more about our GCP in the Laboratory Set Up process.