Closed, not just logged
An issue log is only useful if items actually get resolved, every entry runs to a documented close, tracked against the same site's payment milestones where the two are linked.
What's included
How an issue moves from identified to closed
- Every issue logged in a central tracker at the point it's identified, whether raised during a visit, a remote review, or by the site itself
- Severity and escalation path assigned based on impact to patient safety, data integrity, or protocol compliance
- Owner and target resolution date set at the time of escalation, with the sponsor looped in on anything material
- Follow-up confirmed and documented before an issue is marked closed, not assumed resolved because it wasn't mentioned again
- Open items carried forward into every subsequent monitoring visit report until resolution is confirmed
Surfaced early, not at close-out
Issues affecting essential documents or site compliance are flagged well before the study ends, so document reconciliation at close-out isn't a scramble.
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