Awaiting Approval
1. Purpose
This SOP provides comprehensive guidelines for CHoRUS consortium sites to execute the second data request, including patient selection criteria, required data elements, timeline specifications, and upload procedures. The document outlines the complete workflow from patient identification through data extraction, quality control, and final submission to ensure consistent data collection across all participating sites.
2. Scope
This SOP applies to all CHoRUS consortium participating sites, data managers, clinical informatics teams, and quality assurance personnel responsible for implementing the second data request. It covers patient selection criteria, data element specifications, extraction procedures, quality control measures, and upload protocols for all required clinical domains.
3. Definitions
- Index Admission: The primary hospitalization that qualifies a patient for inclusion in the CHoRUS dataset, serving as the anchor point for data collection.
- Lookback Period: The 365-day period prior to index admission used for collecting relevant clinical history and baseline data.
- Follow-up Period: The post-discharge observation period for capturing outcomes and care transitions.
- Data Request Window: The specific timeframe during which sites must complete data extraction and upload activities.
- Patient Cohort: The defined population meeting inclusion and exclusion criteria for the second data request.
- Data Elements: Specific clinical variables, measurements, and observations required for extraction from participating sites.
- Upload Timeline: The structured schedule for data submission phases and quality control checkpoints.
4. Roles and Responsibilities
- Site Data Manager: Coordinates patient identification, data extraction oversight, and ensures compliance with timeline requirements.
- Clinical Informatics Team: Implements technical data extraction procedures, validates data quality, and manages upload processes.
- Quality Assurance Personnel: Performs comprehensive data validation, identifies discrepancies, and ensures completeness across all required domains.
- Principal Investigator: Provides clinical oversight, approves final data submissions, and ensures regulatory compliance.
- CHoRUS Coordinating Center: Receives uploaded data, performs central quality control, and provides technical support to participating sites.
5. Materials Needed
- Access to electronic health record systems and clinical data warehouses containing patient information.
- CHoRUS data extraction tools and standardized query templates for patient identification.
- OMOP CDM mapping specifications and vocabulary standards for data transformation.
- Secure data upload infrastructure and authentication credentials for CHoRUS data portal.
- Quality control checklists and validation procedures for comprehensive data review.
- Timeline tracking tools and milestone reporting mechanisms for progress monitoring.
6. Procedures
6.1. Patient Selection and Cohort Definition
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Inclusion Criteria Application: Identify patients meeting primary inclusion requirements
- Adult patients (≥18 years) with index hospital admission
- Minimum length of stay requirements as specified in consortium protocols
- Availability of required clinical data elements during specified observation periods
- Active enrollment in participating site's clinical systems during data collection window
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Exclusion Criteria Implementation: Apply systematic exclusion filters
- Patients with incomplete demographic information or missing critical identifiers
- Cases with insufficient clinical data for meaningful analysis
- Admissions occurring outside the specified study timeframe
- Patients who have opted out of research participation
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Cohort Size Validation: Ensure adequate patient population for statistical analysis
- Target minimum patient counts as specified in consortium requirements
- Geographic and demographic diversity requirements across participating sites
- Clinical acuity and diagnostic diversity to support research objectives
6.2. Data Element Extraction and Processing
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Core Clinical Domains: Extract comprehensive data across all required clinical areas
- Demographics, vital signs, laboratory results, medications, procedures
- Diagnoses, nursing assessments, imaging studies, and clinical outcomes
- Social determinants of health and functional status measurements
- Care transitions, discharge planning, and follow-up care coordination
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Temporal Data Collection: Implement structured timeframe-based extraction
- Pre-admission data collection during 365-day lookback period
- Index admission data from arrival through discharge
- Post-discharge follow-up data according to specified observation windows
- Longitudinal care patterns and healthcare utilization tracking
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Data Quality and Completeness: Ensure comprehensive data capture
- Missing data identification and documentation procedures
- Data validation rules and consistency checking protocols
- Outlier detection and clinical plausibility assessment
- Cross-domain data linkage and temporal sequence validation
6.3. Upload Procedures and Timeline Management
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Data Preparation and Formatting: Standardize data for consortium submission
- OMOP CDM transformation and vocabulary mapping procedures
- File format specifications and naming convention compliance
- Data encryption and security protocol implementation
- Metadata documentation and data dictionary completion
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Quality Control and Validation: Implement comprehensive pre-upload review
- Statistical summary generation and distribution analysis
- Clinical logic validation and temporal consistency checking
- Cross-site comparison and outlier identification protocols
- Documentation of data quality metrics and completion rates
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Upload Execution and Timeline Compliance: Complete data submission according to schedule
- Phased upload approach with milestone checkpoints
- Progress tracking and timeline adherence monitoring
- Technical issue resolution and support coordination
- Final submission confirmation and acknowledgment procedures
6.4. Site-Specific Considerations and Customization
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Local System Integration: Adapt procedures to site-specific technical environments
- Electronic health record system compatibility and integration requirements
- Local data warehouse and analytics platform utilization
- Custom query development and validation for site-specific data structures
- Workflow integration with existing clinical informatics processes
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Resource Allocation and Capacity Planning: Ensure adequate resources for timely completion
- Personnel assignment and responsibility distribution across project phases
- Technical infrastructure requirements and system capacity planning
- Timeline coordination with other institutional priorities and commitments
- Contingency planning for technical challenges and resource constraints
6.5. Communication and Coordination Protocols
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Progress Reporting and Status Updates: Maintain regular communication with coordinating center
- Weekly progress reports during active data extraction phases
- Milestone achievement notifications and timeline status updates
- Technical challenge identification and resolution request procedures
- Quality control findings and remediation status reporting
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Technical Support and Issue Resolution: Coordinate with CHoRUS technical team
- Help desk utilization and ticket management procedures
- Escalation protocols for complex technical challenges
- Knowledge sharing and best practice documentation across sites
- Lessons learned capture and process improvement recommendations
7. Quality Control (QC) Procedures
- Patient Count Validation: Verify patient cohort size meets consortium requirements and matches expected demographic distributions
- Data Completeness Assessment: Ensure all required data elements are extracted with acceptable completeness rates across clinical domains
- Temporal Consistency Checking: Validate logical sequence of clinical events and appropriate timeframe coverage for all patients
- Cross-Domain Linkage Verification: Confirm proper linkage between related clinical data elements and consistent patient identification
- Statistical Distribution Review: Analyze data distributions for clinical plausibility and identify potential extraction errors or outliers
- OMOP CDM Compliance Validation: Ensure proper vocabulary mapping and structural compliance with consortium data standards
8. Documentation and Storage
- Extraction Methodology Documentation: Maintain detailed records of patient selection criteria, query logic, and data extraction procedures
- Quality Control Reports: Document all validation procedures, identified issues, and remediation activities throughout the extraction process
- Timeline and Milestone Tracking: Record progress against established deadlines and maintain documentation of any timeline adjustments
- Technical Issue Logs: Capture all technical challenges, resolution approaches, and system modifications required for successful completion
- Data Submission Records: Maintain comprehensive documentation of upload procedures, file manifests, and submission confirmations
- Site-Specific Customizations: Document any local adaptations or modifications to standard procedures for future reference
9. Deviations from the SOP
- Patient Selection Modifications: Any changes to inclusion or exclusion criteria require consortium approval and documentation of impact assessment
- Data Element Substitutions: Alternative data elements or modified collection procedures must be validated for scientific equivalence and approved
- Timeline Extensions: Delays in data submission require formal notification, impact assessment, and revised timeline approval from coordinating center
10. Revision History
| Version | Date | Description |
|---|---|---|
| 1.0 | 2025-10-01 | Initial version based on Data Request 2 specifications |