Collaborators are individually responsible for ensuring that all normal processes of study approval are correctly followed. Collaborators will be asked to confirm that permissions are all obtained before commencing data collection and submission. As above, this study is best regarded as a global audit; we are collecting data that is already available routinely, and are not making any change to normal care.
Approvals might be sought from local clinical audit departments, research departments or institutional review boards, depending on local regulations. It is appreciated that centres in some countries will not have a formalised review process, in which case written permission should be obtained from the next best available source, such as a chief of surgery, or supervising consultant/attending surgeon.
All approvals should be sought at the earliest possible opportunity as they make take some time to obtain. Further FAQs on technical details are supplied below and protocol details should also be referred to in local approvals.