clinical-trial-protocol-skill

Fail

Audited by Gen Agent Trust Hub on Feb 15, 2026

Risk Level: HIGHPROMPT_INJECTIONCOMMAND_EXECUTIONEXTERNAL_DOWNLOADS
Full Analysis
  • [PROMPT_INJECTION] (HIGH): The skill specifically requests a 'Custom Protocol Template' (Step 2.5 in 00-initialize-intervention.md) and processes 'initial_context' which can include 'substantial documentation'. These are high-risk ingestion points for indirect prompt injection that could influence the agent's logic in subsequent protocol generation steps.
  • [COMMAND_EXECUTION] (MEDIUM): In 05-concatenate-protocol.md (Step 2), the skill explicitly instructs the agent to use the cat command via a shell (cat ... > ...). While the paths appear static, this represents a pattern of direct shell interaction which can be exploited if input paths were ever made dynamic.
  • [EXTERNAL_DOWNLOADS] (LOW): The skill relies on external data from ClinicalTrials.gov and FDA guidance documents (Step 1). Per [TRUST-SCOPE-RULE], these are likely trusted sources, but the process of ingesting this unstructured external content into a generative pipeline creates an 'Indirect Prompt Injection' surface.
  • [INDIRECT_PROMPT_INJECTION] (HIGH): Mandatory Evidence Chain:
  • Ingestion points: references/00-initialize-intervention.md (Step 2.5: user-provided template; Step 2: 'initial_context' from rich documentation; Step 1 in README: WebSearch for FDA guidance).
  • Boundary markers: None mentioned in the provided files to separate untrusted data from system instructions.
  • Capability inventory: File system writes (JSON and MD), shell command execution (cat), and complex decision-making (statistical power analysis using scipy/numpy).
  • Sanitization: None described. The skill preserves 'rich context' for later phases without validation or filtering.
Recommendations
  • AI detected serious security threats
Audit Metadata
Risk Level
HIGH
Analyzed
Feb 15, 2026, 10:52 PM