What's included

What the plan defines

• The specific listings and line-level data reviewed manually, distinct from what's covered by programmed edit checks
• Review frequency and cadence — by visit, by cycle, or on a fixed calendar — agreed before conduct starts
• Named reviewer responsibility for each listing, so review ownership doesn't default to whoever notices an issue first
• Escalation paths for findings that require a query versus those that require sponsor or medical monitor input
• Documentation standards so every review cycle leaves an auditable record of what was checked and by whom