Primary data analysis recommendation | Communication strategy probable components |
---|---|
1. That the study continues as planned. | Routine action indicated • Routine communication to PIs and critical collaborators • Distribution of primary data analysis minutes to relevant parties |
2. That the study be modified because policy changes now recommend single-dose vaccination. 3. That the study be stopped due to concerns about participant safety, including social harms. | Urgent action indicated • Expedited communication to PIs, critical collaborators, regulators, and associates • Key messages and briefing materials • Protocol modifications • Participant information • IRB and regulatory approvals • Distribution materials to relevant organizations |