METHODS
Following prospective registration (https://osf.io/bhncy), we developed this international consensus statement on RCT integrity, according to recommended methods,21–25 using a multi-step approach: a) multi-country multidisciplinary stakeholder group composition and engagement; b) evidence synthesis of systematic reviews of RCT integrity; c) anonymised two-round modified Delphi survey; and, d) a final consensus development meeting.