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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.

71

Quality

89%

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SKILL.md
Quality
Evals
Security

Quality

Content

82%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 strong, highly actionable skill body: real executable commands for every tool, a clear 5-step workflow with conditionals and a human sign-off gate, and a well-organized one-level-deep reference bundle. The main improvements are trimming duplicated tool descriptions, adding an iteration loop for REDESIGN/NO-GO verdicts, and moving the forcing-question library into a reference file.

Suggestions

Merge the Purpose section's tool bullets with the Scripts table — they describe the same three scripts twice; keep one (the table) and trim the opening paragraph that restates the frontmatter description.

Add a feedback step to the Workflow for adverse verdicts, e.g., step 4.5: 'If REDESIGN or NO-GO: address the listed blockers (endpoints, enrollment, budget), update study.json, and re-score before routing for sign-off.'

Move the forcing-question library to a reference file (e.g., references/grill_questions.md) and keep a one-line pointer in SKILL.md, since it is only walked by /cs:grill-research-ops; consider the same for the opt-in autoresearch section.

DimensionReasoningScore

Conciseness

The body is dense and operational — no concept-teaching padding (it never explains what power or an endpoint is), and tables/commands carry most of the load. However, the opening paragraph restates the frontmatter description, and the Purpose section's three tool bullets duplicate the Scripts table's descriptions of the same three scripts — trimmable redundancy that fits the score-4 anchor ('minor instances of over-explanation that could be trimmed') rather than the fully lean score-5 anchor.

4 / 5

Actionability

Commands are copy-paste ready and backed by real bundle files: 'python3 scripts/sample_size_estimator.py --design proportions --p1 0.30 --p2 0.45 --dropout 0.15', 'endpoint_selector.py --input endpoints.json --profile {drug|device|biologic|diagnostic|digital-therapeutic}', onboarding commands, and the /ar:setup example. '--sample' invocations cover common cases and every referenced script and template exists in the bundle — fully matching the score-5 anchor.

5 / 5

Workflow Clarity

The 5-step Workflow is clearly sequenced with real checkpoints: 'If >1 primary, plan multiplicity control', 'Trace the effect/difference/HR to a published or anchor-based source', 'inflate for dropout', and the final sign-off gate ('a biostatistician, medical monitor, and regulatory owner sign'). It falls short of the score-5 anchor because there is no feedback loop for adverse verdicts — nothing says what to do when the scorer returns REDESIGN or NO-GO (e.g., address blockers and re-score).

4 / 5

Progressive Disclosure

Structure is good against the actual bundle: three topical reference files are listed with one-line content summaries ('references/study_design_canon.md — ICH E8(R1)... '), all one level deep, and scripts plus the asset template are correctly cited. But content that belongs in a reference is inlined: the ~25-line forcing-question library (walked only by '/cs:grill-research-ops') and the opt-in autoresearch section could be split out, matching the score-4 anchor ('most content is appropriately placed; minor organization gaps') rather than the score-5 anchor ('content appropriately split').

4 / 5

Total

17

/

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.

An excellent description: it explicitly states when to use the skill, enumerates all three concrete capabilities with their outputs (including the GO/GO-WITH-CONDITIONS/REDESIGN/NO-GO verdict vocabulary), defines the output contract (estimate + named human owner), and explicitly distinguishes the sibling regulatory skill. The only weakness is trigger-term coverage missing the most natural user synonyms such as 'clinical trial' and 'power analysis'.

DimensionReasoningScore

Specificity

The description lists multiple concrete actions covering all three of the skill's tools: 'selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging)', 'estimating sample size and power for two-arm designs (means / proportions / survival)', and 'scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision'. Coverage is comprehensive with no identifiable gaps, matching the score-5 anchor rather than the score-4 anchor ('minor gaps in coverage').

5 / 5

Completeness

Both questions are explicitly answered: the 'what' is the three concrete actions (endpoint selection/classification, sample-size/power estimation, feasibility scoring), and the 'when' opens with 'Use when designing a prospective clinical study before submission' plus two additional trigger scenarios. This matches the score-5 anchor ('clearly and explicitly answers both what AND when with concrete trigger phrases'), not the score-4 anchor where the 'when' 'could be more explicit or specific'.

5 / 5

Trigger Term Quality

Good natural keyword coverage: 'designing a prospective clinical study', 'endpoints', 'sample size', 'power', 'feasibility', 'phase-gate'. However, the most common user phrasing 'clinical trial' is absent (only 'clinical study' appears), as are 'power analysis' / 'protocol design', so a few natural synonyms are missing — the score-4 anchor rather than the comprehensive score-5 anchor.

4 / 5

Distinctiveness Conflict Risk

The description carves out a clear niche (prospective study design pre-submission) and proactively disambiguates: 'Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design'. Triggers (endpoint selection, sample size, phase-gate) are distinct, matching the score-5 anchor ('clear niche with distinct triggers; minimal conflict risk').

5 / 5

Total

19

/

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.

Validation — 15 / 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

alirezarezvani/claude-skills

Path

research-ops/skills/clinical-research/SKILL.md

Reviewed

Table of Contents

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