Clinical literature reviewer

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/clinical-literature-reviewer

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Systematic literature review skill for clinical evaluation supporting regulatory submissions

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