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 or in a YouEDC Capture study (menu “Lock readiness” of the project): the whole team sees the same checklist, the project administrator and data managers change it, and every change goes to the project’s audit trail.

Checklist

18 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.

An item that marks itself. “Protocol deviations log finalised and approved” follows the deviations log of YouEDC Trials in the same project: when the current version of the log is signed by its author and approved by another person, the item is done, with the name of the approver and the time of the approval. While the log waits for approval, was returned or was changed after the signature, the item is in progress; its state is not set by hand, the owner, due date and evidence are. When the project does not keep its deviations log in YouEDC Trials, mark the item by hand. Every change of the item is an audit record by “System”. More in YouEDC Trials.

Audit trail review. In a YouEDC Capture study “Audit trail of critical data reviewed” follows the Audit trail review page of the study the same way: in progress while some signals on critical data are reviewed, done when all of them are, with the name of the last reviewer and the time; the item shows how many are reviewed and links to the page. A study without signals on critical data keeps the item by hand.

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.

Lock forecast

The top of the page shows when the study could lock if the team keeps its current pace. It is an estimate, not a plan or a commitment.

Conditional completion (the ring): half is the share of checklist items done, half is how far the counters fell from their peak. Next to it, two bars: how much time has passed from the first patient to the planned lock and how much work is done. When work lags behind time, the plan is at risk.
Pace: how much each counter of each site went down over the last four weeks of its history. New queries that arrive count against the pace. Days to zero = what is left ÷ the pace.
A site waits for its slowest counter, a counter for its slowest site, the checklist goes at the pace items were done in the same four weeks, and the project waits for its slowest part.
“Does not move” and “grows” have no date. The project date then reads “not before”: what stands still has to move first.
“Needed a week” is how much to close each week to make the planned lock. When the pace is below it, the part will not make it: start there.
“Where to look first” gathers the main points: the delay against the plan, parts that stand still or grow, slow counters, items past their due date and items without an owner. Checklist items with counters show their forecast, items past due are marked.

To make the forecast better, enter the counters weekly: each save is kept by its date. A pace needs at least a week of history. Final steps (the meeting, signatures, the authorisation) usually take days of their own; keep them in the plan. The forecast and paces are in the report for the meeting too (sheet “Forecast at the current pace”), and the list of DM projects shows the forecast date of each project.

In a YouEDC Capture study

In a study run in YouEDC Capture itself, the “Lock readiness” page is in the project menu (next to “Form locks”). The project manager, data managers, monitors and viewers see it; site investigators do not, and a user with access to some sites only sees those sites.

Four counters count themselves from the study data, every 10 minutes: open queries, answered but not closed, pages awaiting SDV and expected pages not entered (a visit whose window ended with no form). You cannot type them: in the table they carry an icon and are read-only. The other counters (reconciliations, coding, signatures) are entered as usual.
The history is rebuilt eight weeks back from the dates the study keeps: when a query was opened, answered and closed, when a form was created and verified. So the forecast shows at once, without weeks of waiting.
The forecast works without a checklist. The conditional completion is then how far the counters fell from their peak. The checklist adds what the data does not show: reconciliations, coding, review, sign-offs.
While recruitment goes on, work often arrives faster than it is closed. The page then says so: “No date at this pace”, and shows which parts grow or stand still.

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. The example has a few weeks of counter history, so the forecast shows at once, and one counter of site 03 stands still. The YouEDC Studio twins of demo projects have the forecast filled in too: six weeks of counters and a few items done. Set the counters to zero and close items to see the status change.

Sources

SCDM GCDMP, Database Closure.
SCDM, Clinical Trial Database Lock (draft, 2026).
ICH E6(R3): data integrity and audit trail review.

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.