Clinical Data Management Process
Clinical data management (CDM) is a critical process in the conduct of clinical trials. The goal of CDM is to ensure the accurate and consistent collection, storage, and analysis of clinical trial data. The CDM process typically includes the following steps:
- Planning: This involves defining the data management strategy for the trial, including the data collection processes, data entry methods, and database design.
- Data Collection: This involves the collection of data from various sources, including case report forms, electronic data capture systems, and laboratory results.
- Data Entry: This involves the entry of collected data into the trial database. This can be done manually or through electronic data capture systems.
- Data Validation: This involves checking the accuracy, consistency, and completeness of the data, and resolving any discrepancies or inconsistencies through the use of queries.
- Data Cleaning: This involves the process of cleaning and standardizing the data to ensure consistency and accuracy.
- Data Lock: This is the process of freezing the database for analysis and ensuring that no further changes can be made to the data.
- Database Closure: This involves the finalization of the trial database and the preparation of the data for analysis and reporting.
- Data Archiving: This involves the long-term storage of the trial data for future reference and use.
The Clinical Data Management Process is crucial for ensuring the quality and reliability of the trial data, which is essential for the successful completion and reporting of the clinical trial and the development of new treatments.
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