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AI agent for clinical research coordinators

Study Close-Out Readiness Agent

All close-out items are closed or explained by owner before the close-out date

MonitoringAdministrationScience and researchOperationsHealthcare
See how it worksGet access
Study Close-Out Readiness Agent: what goes in, what the agent does and what you get

What it does

Close-out is when a study discovers open queries, missing signatures, unreturned supplies and lost essential documents. This agent starts earlier. It reads the close-out checklist and compares it to the data system, the regulatory binder and the product records. It builds a list of open items by owner, with due dates. For each owner it drafts a reminder with exactly what is needed. After replies and updates, it rechecks every item and rebuilds the list. It counts down to the close-out visit and flags items at risk of missing it. The principal investigator approves close-out. Edge case: all queries are closed but one is reopened by the sponsor, so the agent moves it back onto the list.

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, continueYes, continueApprovedNoNo 1 STARTS WHEN Close-out countdown begins 2 USES A TOOL Read the checklist, queries, signatures and binderindex 3 DOES Build the open item list by owner and due date 4 USES A TOOL Check product reconciliation status 5 DOES Rank items by risk to the close-out date 6 USES A TOOL Draft reminders to each owner 7 CHECKS THE RESULT Has each owner closed their items by the due date? If not: escalate the overdue items to the PI with arevised plan. Back to step 6. 8 USES A TOOL Reread systems and rebuild the list 9 CHECKS THE RESULT Are there new or reopened items? If not: add them to the owner list and redraftreminders. Back to step 3. 10 YOU APPROVE PI approves close-out 11 RESULT Close-out readiness report
Read the steps as a list
  1. Close-out countdown begins
  2. Read the checklist, queries, signatures and binder index
  3. Build the open item list by owner and due date
  4. Check product reconciliation status
  5. Rank items by risk to the close-out date
  6. Draft reminders to each owner
  7. Has each owner closed their items by the due date?If not: escalate the overdue items to the PI with a revised plan. Back to step 6.
  8. Reread systems and rebuild the list
  9. Are there new or reopened items?If not: add them to the owner list and redraft reminders. Back to step 3.
  10. PI approves close-outThe agent waits here for your OK.
  11. Close-out readiness report

How it decides

An item is closed only with evidence in the system or binder. Items due within two weeks of close-out rank first.

  • Rank items due within 14 days first
  • Escalate after 2 reminders without response
  • Treat a reopened query as a new open item
  • Count an item closed only with a record link

Make it yours

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

  • Start of countdown (default 8 weeks)
  • Reminder timing
  • Escalation rule (default 2 reminders)
  • Checklist version

What keeps you in control

It always asks you first

  • Reminders sent to owners
  • Close-out decision

Hard limits

  • Never closes a query
  • Never sends reminders without coordinator approval

It stops when

  • Done: all items closed and PI approves
  • Stop: sponsor changes the close-out date

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 happensEight weeks out the agent found 23 open items: 14 queries, 5 signatures, 3 binder documents and 1 supply return. It drafted reminders for six owners. In week two, 17 were closed, but the sponsor reopened 2 queries, so the recheck failed. The agent added them, redrafted two reminders and escalated the unreturned supplies to the PI, who approved a revised plan.

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