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clinical-literature-reviewer

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Systematic literature review skill for clinical evaluation supporting regulatory submissions

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Source SKILL.md: https://github.com/a5c-ai/babysitter/blob/HEAD/library/specializations/domains/science/biomedical-engineering/skills/clinical-literature-reviewer/SKILL.md

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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

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