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Lock readiness

Checklist, counters per site and the readiness status before database lock.

A live checklist for database lock instead of an Excel file. Start it long before the lock: you see what is left, who owns it and whether the study will make the planned date. It lives in the DM project (menu “Lock readiness” of the project): the whole team sees the same checklist, the project manager and data managers change it, and every change goes to the project’s audit trail.

Checklist

17 standard items in four areas: data entry and cleaning, reconciliation and external data, coding and review, sign-off and access. Each item has a state (not started, in progress, done, not applicable), an owner, a due date and evidence: the document, listing or date that proves it, filed in the TMF. Items with a lock icon block the lock. If a blocking item does not apply, say why. You can add your own items, for example PK sample reconciliation.

Counters by site

Ten numbers that must be zero at lock: pages not entered, open queries, answered but not closed, pages awaiting SDV, awaiting review, uncoded terms, open SAE reconciliation discrepancies, unreconciled external records, unclassified deviations, unsigned casebooks. Enter them per site or for the whole study with a date and source, by hand or from Excel using the template. An empty cell means “not reported”.

Status

  • Ready for lock: every blocking item is done or not applicable, every counter is zero and up to date.
  • Almost ready: no blockers, but a counter is missing or older than 7 days.
  • Not ready: a blocking item is open or a counter is above zero. With 30 days or less to the planned lock the study is marked “at risk”.

The “Lab normal ranges” item shows how many tests and sites are already in the Lab normal ranges tool.

“Report for the lock meeting” gives an Excel workbook with the summary, blockers, the checklist with evidence and the counters by site. Every change goes to the audit trail; the latest are shown at the bottom of the page.

Example

“Open the example project” creates your DM project DEMO-LOCK three weeks before lock: part of the checklist done, three sites with open queries and SDV, an outdated external data counter. Set the counters to zero and close items to see the status change.

Sources

The portal does not lock anything in another EDC. It shows what is left and gives a report. People decide and sign the lock, and the lock itself is done in the study’s EDC.