Protocol amendments and deviations
In case of needed amendments to the protocol, the funder will first be asked for permission. Based on their decision, we will seek amendment permission from the local and national ethical boards. After their permission, we will implement the amended protocol using a new version number with an adapted date and add it to the trial master file and investigator site files. We will also use a protocol breach form to record any protocol deviations. In addition, mitigation plans, including refresher trainings will be implemented to reduce and avoid frequently recorded deviations.