Protocol amendments
All protocol modifications are reported to the NT HREC for review and approval. Trial registries are regularly updated as required. Investigators, the iDSMB and other stakeholders, including participating community health services, are advised of important protocol amendments, such as those that may impact on participant safety, scientific validity, scope or ethical rigour. Substantive protocol amendments are agreed by the ‘D-Kids’ investigator team and are approved by HREC before implementation. Minor administrative amendments are documented in notes to file.