Clinical Trial Protocol Eligibility Agent Workflow Blueprint

Role: Principal Clinical Informatics Architect specializing in regulatory-grade agentic orchestration systems.

Context

• Target Protocol: {{trial_protocol_id}}
• Primary EHR Architecture: {{ehr_source_system}}
• Clinical Target Condition: {{target_condition}}
• Regulatory Compliance Standard: {{regulatory_framework}}
• Human Oversight Policy: {{human_review_policy}}
• Target Processing Volume: {{throughput_target}}

Task

Develop a comprehensive architectural report outlining a deterministic multi-agent workflow chain that ingests semi-structured EHR records, evaluates inclusion and exclusion criteria against {{trial_protocol_id}}, and routes verified candidates to clinical coordinators.

Method

1. Map the end-to-end agentic workflow topology from raw record ingestion in {{ehr_source_system}} to candidate presentation.
2. Define the schema validation agent responsible for sanitizing and normalizing {{target_condition}} pathology, lab, and demographic data.
3. Detail the deterministic logic agent for structured inclusion/exclusion criteria parsing with zero-hallucination guardrails.
4. Formulate the unstructured extraction agent protocol for parsing oncology and physician notes against {{regulatory_framework}} standards.
5. Design the reconciliation and confidence-scoring agent that calculates protocol fit scores under {{human_review_policy}}.
6. Architect the state persistence and rollback mechanism to maintain session integrity during high-volume processing of {{throughput_target}}.
7. Specify human-in-the-loop (HITL) escalation triggers for ambiguous clinical annotations and borderline biomarker readings.
8. Establish the audit logging and traceability mechanism for all intermediate agent reasoning steps.

Constraints

• MUST enforce {{human_review_policy}} as a blocking gate before any prospective patient identity is exposed to researchers.
• MUST NOT allow non-deterministic agent outputs to overrule hard laboratory exclusion limits.
• All data transformations MUST comply with {{regulatory_framework}} audit trail requirements.
• The workflow must scale to handle {{throughput_target}} without state corruption.

Output format

Provide a technical report with these exact section headings:

1. Executive Workflow Architecture
2. Agent Chain Sequence & Data Contracts
3. Exception Handling & Confidence Gating
4. Regulatory Traceability & Audit Schema
5. Infrastructure & Throughput Feasibility Total word count must be between 900 and 1,300 words.

Self-review

• Are all 6 variables integrated contextually into the pipeline logic?
• Does the report clearly define state management between individual agent nodes?
• Is the human-in-the-loop escalation mechanism strictly non-bypassable?