Clinical data management
Clinical Data Management
Clinical Data Management (pronounced klin-i-kəl dā-tə man-ij-mənt) is a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.
Etymology
The term "Clinical Data Management" is derived from the combination of three words: "Clinical", from the Greek word "klinikos" which means "bed", referring to the patient's bed; "Data", from the Latin word "datum" which means "something given"; and "Management", from the Italian word "maneggiare" which means "to handle".
Definition
Clinical Data Management ensures the collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined in the ICH guidelines.
Related Terms
- Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health outcomes.
- Data Management Plan: A document that describes the data that will be collected or generated during a research project, how the data will be managed, shared and preserved.
- Electronic Data Capture: A computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.
- Clinical Data Interchange Standards Consortium: An organization dedicated to helping to improve medical research by driving interoperability through data standardization.
- Good Clinical Practice: An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
- Data Monitoring Committee: An independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
- Case Report Form: A document that is used in clinical research to collect data in a standardized manner.
- Clinical Research Associate: A healthcare professional who performs many activities related to medical research, particularly clinical trials.
- Clinical Research Coordinator: A person responsible for conducting clinical trials using good clinical practice under the auspices of a Principal Investigator.
- Principal Investigator: The person who is responsible for the scientific and technical direction of the entire clinical study.
- Clinical Study Report: A document that describes in detail the methodology and results of a clinical trial.
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