clinical-literature-reviewer✓ تایید شده

محتوای SKILL.md

---
name: clinical-literature-reviewer
description: Systematic literature review skill for clinical evaluation supporting regulatory submissions
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Clinical Evidence
  skill-id: BME-SK-023
---

# 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

مجوز

مجوز اعلام‌شده: MIT

MIT License

Copyright (c) 2026 a5c-ai

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.

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