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protocol-deviation-classifier

Classify clinical trial protocol deviations as major or minor based on ICH E6/GCP guidelines. Three-impact-dimension assessment (safety, data integrity, scientific validity), confidence scoring, and regulatory compliance reporting with recommended actions.

56

Quality

65%

Does it follow best practices?

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SecuritybySnyk

Passed

No findings from the security scan

Fix and improve this skill with Tessl

tessl review fix ./scientific-skills/Data Analysis/protocol-deviation-classifier/SKILL.md
SKILL.md
Quality
Evals
Security

Quality

Content

63%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is actionable and workflow-oriented with verified executable examples, but it is padded with generic boilerplate, references its bundle file without signaling it, and documents a CLI subcommand that the script does not implement.

Suggestions

Remove generic boilerplate (Risk Assessment table, Security Checklist, Evaluation Criteria/Test Cases, Lifecycle Status) and the contradictory pip-install prerequisite to tighten token use.

Delete or correct the "assess" CLI example, since scripts/main.py exposes only classify, batch, report, interactive, and demo subcommands.

Link references/runtime_checklist.md explicitly from the body and consider moving the classification standards tables and I/O schema examples into reference files.

DimensionReasoningScore

Conciseness

Mostly efficient core content, but padded with generic boilerplate (Risk Assessment table, Security Checklist, Evaluation Criteria/Test Cases, Lifecycle Status) and time-sensitive info ("Next Review Date 2026-03-06") that Claude does not need; a "pip install -r requirements.txt" prerequisite also contradicts the stated no-dependency design.

3 / 5

Actionability

Provides real executable Python API and CLI examples verified against scripts/main.py, but the documented "assess" subcommand does not exist in the script, leaving one example non-executable.

4 / 5

Workflow Clarity

A clear five-step workflow with a fallback branch and a validation Quick Check, but it lacks an explicit validate→fix→retry feedback loop for batch/destructive paths.

4 / 5

Progressive Disclosure

A reference file (references/runtime_checklist.md) exists but is never linked or signaled from the body, while large classification tables, API reference, and I/O schemas are inlined rather than split out.

3 / 5

Total

14

/

20

Passed

Description

67%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

The description is specific and occupies a distinct, low-conflict regulatory niche, but lacks an explicit "Use when..." trigger clause and natural user-facing trigger phrasings, capping completeness and trigger quality.

Suggestions

Add an explicit trigger clause such as "Use when classifying whether a clinical-trial protocol deviation is major or minor, or when reviewing GCP/ICH E6 compliance."

Include natural user phrasings and synonyms (e.g. "deviation severity", "GCP noncompliance") alongside the technical ICH E6/GCP terminology.

DimensionReasoningScore

Specificity

Lists multiple concrete actions ("Classify...as major or minor", "Three-impact-dimension assessment (safety, data integrity, scientific validity)", "confidence scoring", "regulatory compliance reporting with recommended actions") with comprehensive coverage.

5 / 5

Completeness

The "what" is clearly stated (classification, three-dimension assessment, confidence, reporting) but there is no explicit "Use when..." trigger clause, so per the judging guideline completeness is capped at 3.

3 / 5

Trigger Term Quality

Relevant domain keywords like "clinical trial protocol deviations" and "ICH E6/GCP" are present, but natural user phrasings (e.g. "classify a deviation", "is this major or minor") and synonyms are missing.

3 / 5

Distinctiveness Conflict Risk

A clear clinical-trial regulatory niche (ICH E6/GCP, protocol deviation classification) with distinct triggers and minimal overlap risk with other skills.

5 / 5

Total

16

/

20

Passed

Validation

93%

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation15 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

Unknown frontmatter key(s) found; consider removing or moving to metadata

Warning

Total

15

/

16

Passed

Repository
aipoch/medical-research-skills
Reviewed

Table of Contents

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