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tooluniverse-clinical-trial-protocol

Generate a full clinical trial protocol document (ICH E6(R2)/FDA-style) for a drug or medical device, including background, objectives/endpoints, study design, population/eligibility, intervention details, assessment schedule, statistical analysis plan with sample-size justification, safety monitoring, and regulatory/ethical sections. Use when users say "generate a clinical trial protocol", "draft a protocol for [drug/device]", "write up the study design as a protocol document", "create an FDA submission protocol", "help me write section X of a trial protocol", or "calculate the sample size for this trial". Produces a stakeholder-ready Markdown deliverable, not a feasibility score.

Quality

87%

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SecuritybySnyk

Low

Low-risk findings worth noting

SKILL.md
Quality
Evals
Security

Quality

Content

71%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.

A well-structured, actionable workflow body with real commands, named tools, and explicit validation/feedback loops. The dominant defect is bundle-level: the referenced `templates/protocol_template.md` is missing, which undermines Step 5 assembly and leaves one Reference Files entry dangling.

Suggestions

Ship the missing `templates/protocol_template.md` in the bundle — it is referenced in Step 5 and the Reference Files table but does not exist — or remove the reference and inline the 9 section headings so assembly works without it.

Give Step 5 an explicit completion check (e.g. 'confirm all 9 sections from the guide are filled and every numeric claim traces to a tool call') to close the workflow's final validation gap.

Deduplicate the tool listings (Step 2 pathway table vs Step 3 core-tools list) and consolidate the three repeated explanations of the relationship to `tooluniverse-clinical-trial-design` into one section.

DimensionReasoningScore

Conciseness

The body is lean and assumes domain competence — no explanation of what a clinical trial or ICH E6 is, and the anti-fabrication rule is stated once as a terse callout ('LOOK UP, DON'T GUESS'). Minor redundancy keeps it below 5: the drug/device tool names appear in both the Step 2 table and the Step 3 core-tools list, and the relationship to `tooluniverse-clinical-trial-design` is explained three times (intro paragraph, NOT-for section, Integration section). Not 3: there is no genuine padding or teaching of known concepts.

4 / 5

Actionability

Mostly executable: copy-paste-ready commands for all three calculator modes plus `--self-test`, and exact ToolUniverse tool names per section (e.g. `get_clinical_trial_eligibility_criteria`, `FDA_OrangeBook_get_exclusivity`). One real gap: Step 5 directs 'Fill `templates/protocol_template.md`', but that file does not exist in the bundle, so the final assembly step has no executable target. Not 3: the bulk of the guidance is concrete and runnable, not pseudocode or high-level hints.

4 / 5

Workflow Clarity

A clear 5-step sequence with explicit branch points (Step 1 if/else on feasibility inputs, Step 2 drug/device fork), explicit validation (`--self-test` verifies all three formulas), and a genuine feedback loop ('if you don't have a defensible effect-size assumption yet, go back to Step 3'). Not 5: the final step dead-ends at the missing template file and there is no completeness check on the assembled document. Not 3: checkpoints are explicit and recoverable, not implicit.

4 / 5

Progressive Disclosure

Structure and signaling are good — a Reference Files table with per-file descriptions, one-level-deep references, and section-by-section detail correctly delegated to `references/protocol_sections_guide.md`. But scored against the actual bundle, one of the four referenced files, `templates/protocol_template.md`, does not exist, and it is the file the entire Step 5 assembly depends on. A dangling reference that breaks navigation at the deliverable-assembly step is more than the 'minor organization gaps' of the 4 anchor.

3 / 5

Total

15

/

20

Passed

Description

96%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.

A strong description: comprehensive third-person capability listing, explicit 'Use when' trigger phrases covering full and partial tasks, and a clear output-format statement. The only weakness is minor overlap risk with the closely related feasibility skill via the shared sample-size trigger.

DimensionReasoningScore

Specificity

The description lists multiple concrete actions with comprehensive coverage: 'Generate a full clinical trial protocol document (ICH E6(R2)/FDA-style)... including background, objectives/endpoints, study design, population/eligibility, intervention details, assessment schedule, statistical analysis plan with sample-size justification, safety monitoring, and regulatory/ethical sections', and states the deliverable format ('stakeholder-ready Markdown deliverable'). It uses third person ('Generate', 'Produces') with no first/second person. Not 4: the action coverage is comprehensive across every protocol section rather than having minor gaps.

5 / 5

Completeness

Both questions are answered explicitly: 'what' is the enumerated protocol-section deliverable, and 'when' is the concrete 'Use when users say...' clause with six trigger phrases. It even adds an explicit non-goal ('not a feasibility score') clarifying the output type. This matches the 5 anchor exactly ('clearly and explicitly answers both what AND when with concrete trigger phrases').

5 / 5

Trigger Term Quality

Six natural user phrasings are quoted verbatim: 'generate a clinical trial protocol', 'draft a protocol for [drug/device]', 'write up the study design as a protocol document', 'create an FDA submission protocol', 'help me write section X of a trial protocol', 'calculate the sample size for this trial'. These cover full-document requests, partial-section requests, regulatory-submission framing, and the sample-size subtask with synonym variations. Not 4: no common natural phrasing is obviously missing.

5 / 5

Distinctiveness Conflict Risk

It carves a clear niche (full protocol document generation) and differentiates with 'not a feasibility score', but the 'calculate the sample size for this trial' trigger overlaps with the sibling feasibility skill's effect-size/sample-size territory, and the description itself does not name the sibling skills to disambiguate (the body does). 'Mostly distinct; minor overlap risk with closely related skills' fits better than the 5 anchor, whose triggers have essentially no cross-skill ambiguity.

4 / 5

Total

19

/

20

Passed

Validation

100%

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

Validation — 16 / 16 Passed

Validation for skill structure

No warnings or errors.

Repository

mims-harvard/ToolUniverse

Path

plugin/skills/tooluniverse-clinical-trial-protocol/SKILL.md

Reviewed

Table of Contents

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