Standard Operating Procedure for Managing External Laboratory and Diagnostic Services
Purpose
This SOP outlines the procedures for managing external laboratory and diagnostic services in clinical trials and clinical studies. The goal is to ensure the efficient, timely, and quality execution of laboratory and diagnostic services in alignment with study protocols and regulatory standards.
Scope
This SOP applies to all personnel involved in coordinating and managing external laboratory and diagnostic services for clinical trials and clinical studies, including principal investigators, clinical research coordinators, and laboratory and diagnostic service providers.
Responsibilities
- Principal Investigator (PI): Oversees the selection, coordination, and monitoring of external laboratory and diagnostic services.
- Clinical Research Coordinators: Coordinate the activities of external laboratories and diagnostic service providers and ensure compliance with study protocols and timelines.
- Laboratory and Diagnostic Service Providers: Provide services according to study protocols and regulatory standards and ensure timely and accurate data reporting.
Procedure
- Service Provider Selection:
- Select external laboratory and diagnostic service providers based on their qualifications, experience, and track record of quality and compliance.
- Ensure providers have the necessary certifications and accreditations.
- Service Agreement:
- Establish a service agreement with the provider that outlines the scope of work, timelines, data handling, and reporting requirements.
- Sample Collection and Handling:
- Ensure proper procedures for sample collection, labeling, handling, and transportation to maintain sample integrity.
- Document and track sample handling procedures and any deviations.
- Data Reporting:
- Monitor the timely receipt and accuracy of data reports from external laboratories and diagnostic service providers.
- Cross-check data reports with study records to ensure consistency and accuracy.
- Quality Assurance:
- Conduct periodic quality assurance checks on external laboratory and diagnostic service providers.
- Address any quality issues or discrepancies promptly and document corrective actions taken.
- Documentation and Record-Keeping:
- Maintain records of all communications, service agreements, data reports, and quality assurance checks.
- Feedback and Improvement:
- Gather feedback from study personnel and participants on the quality and efficiency of external laboratory and diagnostic services.
- Use feedback to improve future external service management.
Abbreviations Used
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- QA: Quality Assurance
Documents
- Service agreements
- Sample collection and handling procedures
- Data reports and records
- Quality assurance check reports
References
- Regulatory guidelines for laboratory and diagnostic services
- Institutional policies for external laboratory and diagnostic services
SOP Version
Version: 1.0