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claude-codescience

Babysitter clinical-literature-reviewer

Systematic literature review skill for clinical evaluation supporting regulatory submissions

install
source · Clone the upstream repo
git clone https://github.com/a5c-ai/babysitter
Claude Code · Install into ~/.claude/skills/
T=$(mktemp -d) && git clone --depth=1 https://github.com/a5c-ai/babysitter "$T" && mkdir -p ~/.claude/skills && cp -r "$T/library/specializations/domains/science/biomedical-engineering/skills/clinical-literature-reviewer" ~/.claude/skills/a5c-ai-babysitter-clinical-literature-reviewer && rm -rf "$T"
manifest: library/specializations/domains/science/biomedical-engineering/skills/clinical-literature-reviewer/SKILL.md
tags
#clinical-review#regulatory-compliance#evidence-synthesis#medical-device#literature-screening#systematic-review
source content

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