# Clinical Literature Reviewer

> Systematic literature review skill for clinical evaluation supporting regulatory submissions

- Skill: `a5c-ai/clinical-literature-reviewer` (Agent Skill)
- Install (CLI): `npx skillmds@latest add a5c-ai/clinical-literature-reviewer`
- Raw SKILL.md: https://api.skillmd.com/api/skills/a5c-ai/clinical-literature-reviewer/raw
- Safety review: pending (external: skill-scanner PASS, skillspector PASS)
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Research & Search
- Author: a5c-ai (https://skillmd.com/u/a5c-ai)
- Updated: 2026-09-09
- Page: https://skillmd.com/skills/a5c-ai/clinical-literature-reviewer

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# Clinical Literature Reviewer Skill

## Purpose

The Clinical Literature Reviewer Skill conducts systematic literature reviews for clinical evaluation, supporting medical device regulatory submissions with evidence synthesis per MEDDEV 2.7/1 and FDA guidance.

## Capabilities

- Literature search strategy development (PubMed, Embase, Cochrane)
- PICO framework application
- Abstract screening criteria
- Data extraction templates
- Appraisal of clinical data quality
- Evidence synthesis and summary tables
- MEDDEV 2.7/1 compliance checking
- Bias assessment tools
- Meta-analysis support
- Gap analysis for clinical evidence
- Ongoing literature surveillance

## Usage Guidelines

### When to Use
- Conducting clinical evidence reviews
- Supporting CER development
- Identifying evidence gaps
- Preparing regulatory submissions

### Prerequisites
- Clinical claims defined
- Search strategy approved
- Inclusion/exclusion criteria established
- Appraisal methodology selected

### Best Practices
- Document search methodology completely
- Apply consistent screening criteria
- Assess study quality systematically
- Synthesize evidence objectively

## Process Integration

This skill integrates with the following processes:
- Clinical Evaluation Report Development
- Clinical Study Design and Execution
- EU MDR Technical Documentation
- Post-Market Surveillance System Implementation

## Dependencies

- PubMed API
- Cochrane Library
- Embase database
- Systematic review tools
- Reference management software

## Configuration

```yaml
clinical-literature-reviewer:
  databases:
    - PubMed
    - Embase
    - Cochrane
    - Web-of-Science
  review-types:
    - systematic
    - scoping
    - rapid
  appraisal-tools:
    - GRADE
    - Oxford-CEBM
    - Cochrane-RoB
```

## Output Artifacts

- Search strategies
- Screening logs
- Data extraction tables
- Quality appraisal forms
- Evidence synthesis reports
- PRISMA diagrams
- Summary of evidence tables
- Gap analysis reports

## Quality Criteria

- Search comprehensive and reproducible
- Screening criteria consistently applied
- Data extraction accurate
- Quality appraisal systematic
- Synthesis methodology appropriate
- Documentation meets MEDDEV 2.7/1