a5c-ai 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