Basic Terminologies Used in Clinical Data Management
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Clinical Data Management (CDM) involves the collection, organization, validation, and analysis of data obtained during clinical trials and studies.
Here are some basic terminologies used in clinical data management:
1. Case Report Form (CRF): A paper or electronic document used for recording and collecting data during a clinical trial. It includes various fields for capturing study-related information, such as patient demographics, medical history, adverse events, and treatment details.
2. Data Management Plan (DMP): A document that outlines the strategies, processes, and procedures for data collection, cleaning, validation, and analysis during a clinical trial. It specifies the roles and responsibilities of the data management team and provides guidelines for ensuring data quality and integrity.
3. Data Validation: The process of verifying the accuracy, completeness, and consistency of collected data. It involves performing checks and validation rules to identify any discrepancies, errors, or missing data.
4. Data Cleaning: The process of correcting errors, inconsistencies, and discrepancies in the collected data. It involves reviewing data for accuracy, identifying outliers, and resolving any issues or inconsistencies found.
5. Data Query: A question or clarification raised by the data management team to resolve discrepancies or obtain additional information regarding the collected data. Data queries are sent to investigators or site staff for resolution.
6. Electronic Data Capture (EDC): The process of capturing and storing clinical trial data electronically using specialized software or systems. EDC systems replace paper-based CRFs and provide tools for data entry, validation, and management.
7. Data Dictionary: A document that defines the structure, format, and content of the collected data. It specifies the variables, their allowable values, data types, and any derived or calculated variables used in the study.
8. Data Monitoring Committee (DMC): An independent group of experts responsible for reviewing the accumulated data during a clinical trial. The DMC ensures participant safety, assesses data quality, and may make recommendations regarding study continuation or modification.
9. Query Resolution Log: A document used to track and document the progress and resolution of data queries. It records the query details, the individuals involved in the resolution process, and the final resolution status.
10. Data Lock: The process of finalizing and freezing the clinical trial data after ensuring its quality, completeness, and accuracy. Data lock typically occurs after all data queries have been resolved, and no further data changes are allowed.
These are some fundamental terminologies used in clinical data management. However, the field is extensive, and there are additional concepts and terms specific to certain areas or stages of clinical data management.
