Protocol requirements management
Protocol Guard
Turns complex protocols and related documents into a versioned map of criteria, procedures, timelines and risks.
Module purpose
Reduce manual document review while giving downstream modules one explainable rule set—without replacing expert interpretation.
Status
Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.
Inputs
- Protocol and amendments
- Eligibility criteria
- Visit schedule and time windows
- Related contractual and regulatory requirements
How it works
- Links extracted content to its source
- Normalises criteria and AND / OR / NOT logic
- Compares versions and highlights change
- Routes ambiguity and risk to expert review
Outputs
- Machine-readable protocol map
- Ambiguity and risk register
- Version history
- Traceable rules for Recruit and Orchestrator
Human checkpoints
- Medical interpretation
- Legal and regulatory assessment
- Approval of the active rule version
Automation boundaries
- Does not approve a protocol
- Does not replace medical expertise
- Does not treat ambiguity as fact
Module video
Protocol Guard: a protocol as a working map
The film explains the module with a synthetic example. It is not evidence of clinical effectiveness, validation, compliance or regulatory approval.
Open the full video series →