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