Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
RECRUITMENT
Modifications to study protocol, informed consent forms, and recruitment materials will all be submitted for review to both the HSRC and Harvard IRBs. The study will be reviewed annually by both IRBs when relevant information about recruitment, enrolment, follow-up, AEs and SAEs, and protocol deviations and violations are submitted as a unified report.