Receipt and Review of Data
The receipt and review of data is a critical component of clinical data management in clinical trials. This process involves the collection and review of data from multiple sources, including patient case report forms, laboratory results, and adverse event reports. The goal of the receipt and review process is to ensure that all relevant data is captured accurately and completely, and that the data is ready for analysis and reporting.
The receipt and review process typically involves several steps:
- Data collection: Data is collected from various sources, including electronic case report forms, laboratory results, and adverse event reports.
- Data entry: Data is entered into the Clinical Data Management System (CDMS) and is checked for accuracy and completeness.
- Data validation: Data is subjected to a series of checks and validations to ensure that it meets pre-defined quality criteria, such as range checks and consistency checks.
- Data reconciliation: Discrepant data is identified and reconciled through a process of data queries and resolution.
- Data cleaning: Data is cleaned and transformed to ensure that it is in a standardized format and ready for analysis.
- Data review: Data is reviewed by clinical data management staff and other stakeholders, such as statisticians and clinical trial monitors, to ensure its accuracy and completeness.
The receipt and review process is an iterative process that continues throughout the course of the trial. The timely and accurate receipt and review of data is essential for the success of clinical trials and the development of new treatments.
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