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AI agent for clinical data managers

Database Lock Readiness Agent

A true, item-level view of what stands between now and database lock

Database Lock Readiness Agent: what goes in, what the agent does and what you get

What it does

Locking a clinical database means every item is clean, coded, reconciled and signed, and open items found at the last minute make lock slip. This agent runs the lock readiness checklist: open queries, uncoded terms, failed edit checks, unreconciled external data, missing pages and outstanding signatures. It pulls the real status from each system instead of trusting a manual tracker. For each open category it lists the specific items and their owners. It then estimates whether lock is achievable by the target date given recent closure rates. Where an item blocks lock, it flags it with the action needed and rechecks on the next run. It reports more often as the date nears. You approve declaring the database ready to lock. Edge case: a page marked complete with a pending query counts as open.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedNo 1 STARTS WHEN Lock readiness review 2 USES A TOOL Pull status from queries, coding, edit checks andreconciliation 3 USES A TOOL Pull missing pages and outstanding signatures 4 DOES List open items by category with owners 5 CHECKS THE RESULT Are all blocking items closed? If not: flag each open item with the action and owner,and recheck on the next run. Back to step 2. 6 DOES Estimate readiness against the target date fromclosure rates 7 DOES Draft the readiness report 8 YOU APPROVE Data manager approves declaring ready to lock 9 RESULT Lock readiness report
Read the steps as a list
  1. Lock readiness review
  2. Pull status from queries, coding, edit checks and reconciliation
  3. Pull missing pages and outstanding signatures
  4. List open items by category with owners
  5. Are all blocking items closed?If not: flag each open item with the action and owner, and recheck on the next run. Back to step 2.
  6. Estimate readiness against the target date from closure rates
  7. Draft the readiness report
  8. Data manager approves declaring ready to lockThe agent waits here for your OK.
  9. Lock readiness report

How it decides

It counts an item ready only when every linked check is closed, and declares lock readiness only when no blocking item remains.

  • Count an item open if any linked check is open
  • Declare ready only with no blocking items
  • Estimate feasibility against the lock date

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Checklist categories
  • What counts as blocking
  • Report frequency
  • Lock date and owners

What keeps you in control

It always asks you first

  • Declaring the database ready to lock

Hard limits

  • Does not lock the database itself
  • Uses live system status, not manual trackers alone

It stops when

  • Done: database confirmed ready or blockers listed
  • Stop: a status source is unavailable

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensTwo weeks before the June 28 lock of study GI-207, the manual tracker showed all clear, but the agent found 34 open queries, 6 uncoded terms and one unreconciled lab transfer. A page marked done had a pending query, so it counted as open. It listed owners and estimated lock was achievable if queries closed within a week. Five days later all items were closed, and the data manager approved.

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