Continuous, not a scramble at LPLV
Reconciliation runs the whole study, so the gap between last patient last visit and a clean TMF is days, not weeks of tracking down missing signatures.
What's included
How completeness is confirmed, not assumed
- Site regulatory binder and TMF cross-checked against the ICH-GCP essential document list on a recurring cadence throughout conduct, not only at close-out
- Missing, outdated, or unsigned documents flagged and routed back to the site for correction while the study is still active
- Version control confirmed on protocol amendments, informed consent forms, and delegation logs, so the TMF reflects the current approved set
- A completeness log maintained per site, showing outstanding items and resolution status at any point in time
- Final reconciliation completed ahead of the close-out visit, so the visit confirms readiness rather than chasing paperwork
Ready before the visit, not during it
Document status is confirmed before the close-out visit, so that visit and final payment reconciliation can proceed without waiting on outstanding files.