Protocol amendment release simulator

A trial-operations app requests a protocol amendment release. VeriProof checks sponsor rules before the site receives it. Choose a fictional site to see the result.

How the simulation works

The website proposes approval. VeriProof checks the rules.

  1. The website simulates the agent

    Every prepared scenario starts with the website acting as an AI agent and proposing approval.

  2. VeriProof enforces the business rules

    VeriProof checks the proposed approval against the rules prepared for this demo.

  3. The website applies the result

    VeriProof returns one of five outcomes: Allow, Warn, Transform, Escalate, or Deny. The website applies that outcome to the simulated action.

In a real integration, your application applies VeriProof's result before the proposed action proceeds.

  1. Choose what the agent approvesEvery prepared scenario starts with simulated agent approval
  2. See VeriProof's decisionPass, escalate, or stop based on the business rules

Choose a scenario

The protocol amendment

Each release is set up to end differently. Pick one, or change the site-readiness facts below.

Study site
Northbridge Research Center
Amendment state
Approved amendment
Final ethics approval
Final ethics approval pending
Site activation
Site is active
Required site training complete
Yes
Change scenario details

This sample run requests release of VPR-CT-402 Amendment 3 to Northbridge Research Center. No participant or clinician data is included.

The app requests release. VeriProof stops the amendment because final ethics approval is still pending.

Records created in this public demo can be seen by other visitors, so use the sample data rather than your own.

Configuration details

How this demo is set up

Review the application settings, rules, and evidence fields used in this simulator.

VeriProof setup

Industry
Healthcare & Life Sciences · Clinical Trials
Application
Clinical Trial Protocol Review
Environment
Public demo workspace
Rule enforcement
On, rules can stop site releases
Rule set
Protocol amendment release controls

Related frameworks

Industry context: ICH E6(R3) Good Clinical Practice · FDA 21 CFR Part 11 · FDA 21 CFR Part 312 · EU Clinical Trials Regulation and CTIS

The app's own checks

This demo starts with a trial-operations app that makes the first call before VeriProof is involved.

  • Request release of an approved amendment to an active site.
  • Route draft amendments and inactive sites to trial operations.
  • Keep the protocol and site references with the release record.

The company rules VeriProof enforces

After the app decides, VeriProof checks requirements the trial sponsor set. The release cannot skip this step.

  • Stop a release request until final ethics approval is recorded.
  • Route an untrained site to trial operations before it receives an amendment.
  • Record the app decision, rule check, and final outcome as separate facts.
Review the details saved with each run

The decision record brings the sample protocol, site readiness, and policy result together. Each result shows whether the record was saved.

protocol_id / protocol_version

The sample protocol reference and amendment version used in this release.

site_name / site_id

The study site reference kept with the release record.

amendment_status / site_activation_status

The app-level readiness facts used before the release is checked.

ethics_approval_status / site_training_complete

The rule facts that can stop or route the release to trial operations.

authorized_reviewer_confirmed

A recorded trial-operations confirmation for the sample release.

local_decision / governance_action / final_decision

The app decision, rule check, and final outcome saved as separate facts.