What is Clinical Data Management?
Clinical data management (CDM) refers to the organization, integration, maintenance and security of clinical trial data collected during drug and medical device research and development. As clinical trials have become larger, more complex and global in nature, the need for robust CDM processes and teAchnologies has grown exponentially. Clinical data management encompasses all activities related to planning, collection, quality control and database lock of clinical data.
Data Collection and Management Systems
Modern clinical trials generate massive amounts of data from a variety of sources including electronic health records, case report forms, lab results and imaging. Effective data collection and management systems are crucial for streamlining the capture, cleaning and validation of this data. Many companies have adopted electronic data capture (EDC) solutions which allow sites to directly enter data into a centralized electronic database in real-time. This eliminates errors from duplicate data entry and expedites database build. Leading EDC platforms also offer integrated randomization and supply management, medical coding, audit trail tracking and regulatory reporting capabilities.
Quality Control and Data Cleaning
Despite utilizing advanced electronic data collection tools, Clinical Data Management will always require extensive quality control and cleaning. Thorough source data verification, data query resolution, tracking of protocol deviations and missing data investigations are critical to ensure only high quality, consistent data is available for analysis. Experienced clinical data managers perform systematic reviews of the data using validation checks and medical review of outliers. Any data discrepancies or issues uncovered during monitoring visits must also be addressed and resolved in a timely manner. Robust data cleaning procedures are necessary to get clinical databases ready for database lock and analysis.
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