SDV Perfection Checklist
SDV Perfection Checklist
General Items
- Regularly review and update the checklist as needed
- Facilitate team meetings for progress updates
- Encourage feedback from all team members
Pre-Study Preparation
- Define study objectives clearly
- Select appropriate study design
- Identify target population
- Ensure ethical approvals are obtained
- Prepare study protocol and standard operating procedures (SOPs)
Site Selection and Preparation
- Conduct feasibility assessments for potential sites
- Evaluate site staff qualifications and experience
- Ensure site has necessary equipment and facilities
- Confirm site readiness for patient recruitment
- Provide site training on study procedures and protocols
Patient Recruitment and Enrollment
- Develop comprehensive recruitment strategies
- Screen and enroll eligible participants
- Obtain informed consent from all participants
- Maintain participant confidentiality and data integrity
- Monitor enrollment progress and adjust strategies as needed
Data Management and Monitoring
- Implement data collection tools and databases
- Ensure data accuracy through regular checks
- Establish data monitoring plan
- Conduct regular site visits for quality assurance
- Address any data discrepancies promptly
Study Execution and Compliance
- Adhere to timelines and milestones
- Maintain communication with all stakeholders
- Ensure compliance with regulatory requirements
- Document all study-related activities thoroughly
- Provide ongoing training and support to site staff
Final Review and Reporting
- Conduct final data analysis and interpretation
- Prepare comprehensive study report
- Share findings with stakeholders and participants
- Submit reports to regulatory authorities as required
- Plan for publication and dissemination of results
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