News & Media

Updated Guidance on QA Oversight of Laboratories Published

Following a detailed review by a team of specialists from across the Network, the QA Operations Group has published updated guidance on QA oversight of laboratories.

This revised suite of materials provides guidance to CTUs assessing the suitability of laboratories processing and/or analysing samples used in clinical trials. It includes:

• Guidance for CTUs assessing the suitability of Labs processing research samples
• Guidance on training requirements for labs processing research samples
• A flowchart for oversight of laboratories by CTUs
• A Self-Assessment Questionnaire

We are very grateful for the assistance provided the MHRA in reviewing and updating this guidance, as well as the helpful feedback given by those who used the original versions.