Backgrouond: Looking for, processing and acting on protocol deviations are an important part of ensuring good trial conduct.There are definitions of protocol deviations in the ICH Good Clinical Practice series but there is little practical advice on the process for protocol deviations. Methods and Results: Using semi-structured discussions between 5 CTUs in the UK and a CRO in Kenya, we developed a protocol deviation framework Summary: We hope this framwork will improve protocol deviation process and efficiency. It will also serve as a launchpad for further research on the collection, processing and relevant action for protocol deviations.