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ewankeynes

Protocol Deviation Classifier

by ewankeynes · GitHub ↗ · v0.1.0 · MIT-0
cross-platform ✓ Security Clean
251
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Install in OpenClaw
/install protocol-deviation-classifier
Description
Determine whether an incident in a clinical trial is a "major deviation" or "minor deviation". Function: Automatically classify protocol deviations in clinic...
Usage Guidance
This skill appears internally consistent and runs locally without requesting credentials or remote installs, but before using it on real clinical data: (1) review the full scripts/main.py file (the provided file was truncated in the listing) to ensure there are no hidden network calls or subprocess invocations, (2) test the classifier on known examples and perform clinical/regulatory review—do not rely solely on automated outputs for regulatory decisions, (3) avoid sending personally identifiable or protected health information to unfamiliar environments; run the tool in a controlled environment or sanitize inputs, and (4) if you plan to integrate this into workflows, add logging, auditing, and human review gates to meet GCP/regulatory requirements.
Capability Analysis
Type: OpenClaw Skill Name: protocol-deviation-classifier Version: 0.1.0 The protocol-deviation-classifier skill bundle is a legitimate tool designed for clinical trial quality management. The core logic in `scripts/main.py` uses rule-based scoring and regular expressions to classify protocol deviations according to GCP/ICH E6 standards. The code relies solely on the Python standard library, contains no network requests, and performs no suspicious file system operations or command executions. The documentation in `SKILL.md` is well-structured and lacks any instructions that could be interpreted as prompt injection or malicious intent.
Capability Assessment
Purpose & Capability
Name, description, SKILL.md, and the included Python module align: the project is a local classifier for clinical trial protocol deviations and the code defines patterns, heuristics, and CLI/API entry points consistent with that purpose.
Instruction Scope
SKILL.md and the visible portions of scripts/main.py restrict behavior to local classification, reporting, and CLI interactions. The instructions do not ask the agent to read unrelated system files, access environment secrets, or post data to external endpoints.
Install Mechanism
No install spec is present and requirements.txt lists only small stdlib-like packages (dataclasses, enum). There is no evidence of remote downloads or archive extraction in the provided material.
Credentials
The skill declares no required environment variables, no credentials, and no config paths. That matches the described functionality. Note: the classifier will process possibly sensitive clinical identifiers provided as input, which is expected but requires appropriate handling by the user.
Persistence & Privilege
always:false and no install hooks or persistent system modifications are present in the visible files. The skill does not request elevated or persistent privileges.
How to Use
  1. Make sure OpenClaw is installed (local or Docker)
  2. Run the install command in chat: /install protocol-deviation-classifier
  3. After installation, invoke the skill by name or use /protocol-deviation-classifier
  4. Provide required inputs per the skill's parameter spec and get structured output
Version History
v0.1.0
Initial release of protocol-deviation-classifier. - Automatically classifies protocol deviations in clinical trials as "major" or "minor" based on GCP/ICH E6 standards. - Assesses impact of deviations on subject safety, data integrity, and scientific validity. - Provides CLI and Python API for single or batch classification, with report generation. - Includes clear deviation classification standards and examples for both major and minor categories. - Generates structured JSON results with confidence scores and regulatory basis references. - Pure Python implementation with no third-party dependencies; supports Chinese clinical trial scenarios.
Metadata
Slug protocol-deviation-classifier
Version 0.1.0
License MIT-0
All-time Installs 0
Active Installs 0
Total Versions 1
Frequently Asked Questions

What is Protocol Deviation Classifier?

Determine whether an incident in a clinical trial is a "major deviation" or "minor deviation". Function: Automatically classify protocol deviations in clinic... It is an AI Agent Skill for Claude Code / OpenClaw, with 251 downloads so far.

How do I install Protocol Deviation Classifier?

Run "/install protocol-deviation-classifier" in the OpenClaw or Claude Code chat to install it in one step — no extra setup required.

Is Protocol Deviation Classifier free?

Yes, Protocol Deviation Classifier is completely free, licensed under MIT-0. You can download, install and use it at no cost.

Which platforms does Protocol Deviation Classifier support?

Protocol Deviation Classifier is cross-platform and runs anywhere OpenClaw / Claude Code is available (cross-platform).

Who created Protocol Deviation Classifier?

It is built and maintained by ewankeynes (@ewankeynes); the current version is v0.1.0.

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