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AI agent for clinical research coordinators

Research Protocol Version Agent

Every working file references the current approved protocol version, with procedure changes decided by the investigator.

ComplianceScience and research
See how it worksGet access
Research Protocol Version Agent: what goes in, what the agent does and what you get

What it does

Research teams keep working from protocol versions that have been superseded, so data gets recorded the old way. This agent runs when a new protocol version is approved. It finds every project file that references the protocol, such as data sheets, consent forms and training notes, and compares each reference with the approved version. When the only difference is the version number, it prepares a version-aligned working copy. When the new version changes a procedure itself, like adding a required observation, it does not rewrite the procedure but sends the difference to the investigator. It then checks the copies for missed references. Original files stay untouched until the coordinator accepts the corrections. Edge case: a file citing a protocol from another study with the same name is left alone.

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 New protocol version approved 2 USES A TOOL Find files that reference the protocol 3 USES A TOOL Compare each reference with the approved version 4 CHECKS THE RESULT Is the difference only a version reference (not aprocedure change)? If not: send the procedure difference to theinvestigator. Back to step 3. 5 DOES Prepare version-aligned working copies 6 CHECKS THE RESULT Do the copies cite the approved version everywhere? If not: fix the missed references. Back to step 5. 7 YOU APPROVE Coordinator accepts the corrections 8 RESULT Protocol reference correction pack
Read the steps as a list
  1. New protocol version approved
  2. Find files that reference the protocol
  3. Compare each reference with the approved version
  4. Is the difference only a version reference (not a procedure change)?If not: send the procedure difference to the investigator. Back to step 3.
  5. Prepare version-aligned working copies
  6. Do the copies cite the approved version everywhere?If not: fix the missed references. Back to step 5.
  7. Coordinator accepts the correctionsThe agent waits here for your OK.
  8. Protocol reference correction pack

How it decides

It updates version references automatically in copies, but sends any substantive procedure difference to the investigator.

  • Reference-only differences: corrected in copies.
  • Procedure differences: investigator.
  • Originals untouched until accepted.

Make it yours

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

  • Folders and systems to search for protocol references
  • Who receives procedure differences (default: principal investigator)
  • Who accepts corrections (default: study coordinator)
  • Whether to notify staff after acceptance (default yes)
  • File naming for working copies

What keeps you in control

It always asks you first

  • Protocol approval
  • Experimental changes

Hard limits

  • Never rewrites procedures.
  • Works in copies.

It stops when

  • Done: all references aligned or with the investigator.
  • Stop: approved version unclear.

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 happensProtocol v4 is approved on August 2. The agent finds 23 files citing it. Twenty only cite v3 and get aligned copies. The data sheet still follows v3, and v4 adds a required 30-minute observation, so the check routes that difference to the investigator. A recheck finds one missed footer reference, which it fixes. The coordinator accepts all corrections on August 5.

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