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clinical-research

Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design.

68

Quality

83%

Does it follow best practices?

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SecuritybySnyk

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The canonical home for this skill is clinical-research in alirezarezvani/claude-skills

SKILL.md
Quality
Evals
Security

Quality

Content

75%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 dense, well-structured body with concrete commands, a clear five-step workflow, and well-organized reference signaling. It scores 4 across the board: lean but with minor redundancy, actionable but referencing scripts that are not bundled, and clearly structured but pointing to reference files that are absent.

Suggestions

Ship the referenced bundles (scripts/sample_size_estimator.py, endpoint_selector.py, phase_gate_scorer.py, onboard.py, ar_evaluator.py; references/*.md; assets/protocol_synopsis_template.md) so the signaled navigation resolves and actionability examples are verifiable.

Add an explicit validate-and-retry checkpoint between tool runs in the Workflow section (e.g., 'if phase_gate_scorer returns REDESIGN, revise the synopsis and re-run steps 2-4') to lift workflow_clarity toward 5.

Trim the redundancy between the intro framing and the Purpose section, and consider moving the inlined forcing-question library to its own reference file, to tighten conciseness and progressive disclosure.

DimensionReasoningScore

Conciseness

Assumes Claude's competence (no definition of ICH, clinical trials, or statistics) and every section earns its place, but the Purpose section restates the intro framing and the 'seven questions' list restates the onboarding config keys. It is not 5 because those small redundancies could be trimmed; it is not 3 because the body is mostly tight and information-dense.

4 / 5

Actionability

Provides concrete executable commands with real flags ('endpoint_selector.py --input endpoints.json --profile {drug|device|...}', '--sample', '--output {human,json}') and a scripts table. It is not 5 because the referenced scripts/ directory is absent, the examples cannot be verified, and 'sample_size_estimator.py --design {means|proportions|survival} ...' leaves arguments as an ellipsis.

4 / 5

Workflow Clarity

A clear five-step workflow is sequenced with named steps, and the phase_gate_scorer's GO/REDESIGN/NO-GO verdict plus the forcing-question lock-in (1-2 before 3-5) act as checkpoints. It is not 5 because the main tool-run steps lack an explicit validate-then-retry loop, and not 3 because checkpoints are present via the phase-gate gate and the grilling discipline.

4 / 5

Progressive Disclosure

The body is a well-signaled overview pointing one level deep to clearly labeled references (References section lists study_design_canon.md / endpoint_and_power.md / trial_operations.md; Scripts table; Onboarding). It is not 5 because the referenced references/ and scripts/ directories do not exist, so the signaled navigation cannot resolve, and the inlined forcing-question library is long enough to warrant its own reference.

4 / 5

Total

16

/

20

Passed

Description

92%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 high-quality, specific description that names concrete design actions, gives an explicit 'Use when' trigger, and explicitly distinguishes itself from the sibling ra-qm-team skill. Its only weakness is trigger-term breadth, where domain jargon ('phase-gate') and a few lay synonyms ('clinical trial', 'protocol') are missing.

DimensionReasoningScore

Specificity

Lists multiple concrete actions — 'selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging)', 'estimating sample size and power ... (means / proportions / survival)', and 'scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision' — which is comprehensive coverage of the domain. It is not a 4 because the actions are several and specifically scoped rather than having minor gaps.

5 / 5

Completeness

Explicitly answers both what ('selecting and classifying endpoints', 'estimating sample size and power', 'scoring a study plan') and when ('Use when designing a prospective clinical study before submission') with concrete trigger phrases. It is not 4 because the 'when' clause is explicit and specific, not merely implied.

5 / 5

Trigger Term Quality

Strong natural terms ('clinical study', 'endpoints', 'sample size', 'power', 'study plan', 'feasibility', 'phase-gate') with good synonym coverage, but 'phase-gate' is domain jargon and a few common lay variations ('clinical trial', 'randomized', 'protocol') are absent. It is not 5 because the anchor expects comprehensive natural-term coverage including synonyms, which is not quite complete here.

4 / 5

Distinctiveness Conflict Risk

Occupies a clear niche (clinical study design pre-submission) and explicitly states 'Distinct from ra-qm-team, which handles the regulatory/QM submission ... not the study design,' minimizing conflict risk. It is not 4 because the boundary with the nearest sibling skill is stated explicitly rather than left to minor overlap.

5 / 5

Total

19

/

20

Passed

Validation

87%

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

Validation14 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

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

Warning

referenced_paths_exist

Referenced path issues: 14 missing

Warning

Total

14

/

16

Passed

Repository
alirezarezvani/claude-skills
Reviewed

Table of Contents

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