CLINICAL DATA
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What is clinical data management? Clinical data management is a key group within the clinical trial process. It plays an essential role in the data collection phase of clinical research. The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free. Therefore, clinical data management is different from traditional data management.
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Why is the clinical data manager role important?
The clinical data manager collaborates with various groups (clinical operations, medical experts, clinical sites) to get the highest data quality. As the point of contact for data, the manager plays a key part in the success of a clinical trial. A person in this pivotal role may find themselves greatly appreciated one minute, but called on to sort out a problem the next – depending on the data issue.
What skills are required to be an effective clinical data manager?
Clinical data managers work closely with other groups within a clinical trial to ensure that data is collected, managed and reported in a timely manner, accurately, and securely. The clinical data manager must understand good clinical practices (GCPs), protocol, protocol deviations, metadata, basic SDTM mapping, programming and Excel. In addition, the clinical data manager must communicate data issues to team members and the other key groups promptly throughout the length of the trial.
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