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Term of the Day
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
A central laboratory plays an important role in clinical trials by providing a centralized location for the analysis of study samples, including blood, urine, and tissue samples. The main functions of a central laboratory in a clinical trial include:
- Sample processing and analysis: Central laboratories receive, process, and analyze study samples according to the study protocol. This may involve performing various tests to measure biomarkers, drug concentrations, or other study-specific endpoints.
- Quality control: Central laboratories are responsible for ensuring the accuracy and reliability of study data by implementing quality control measures, such as sample tracking, instrument calibration, and data verification.
- Standardization: Central laboratories often use standardized methodologies and procedures to ensure consistency across study sites and to minimize variability in study results.
- Data management: Central laboratories may provide data management services, such as data analysis and reporting, and may work with study sponsors to develop customized data reports.
- Regulatory compliance: Central laboratories are subject to regulatory oversight and are required to adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which ensure the integrity and reliability of study data.