In clinical trials, a sophisticated network of computerized systems often plays a vital role in supporting various trial activities, including screening, randomization, drug supply, data capture and analysis, and tracking patient outcomes, among others. With the utilization of multiple systems in each trial, the volume and intricacy of data have significantly increased. Consequently, efforts to reconcile and analyze this vast amount of data often lead to delays in study results. Understanding effective data analysis techniques and navigating common challenges is imperative for optimizing results and attaining desired outcomes.
In this article, we will explore:
- Key data management elements that must be considered to effectively manage and employ technology systems in clinical trials.
- The basic expectations for ensuring data integrity.
- Maintaining the blind during data review and data mapping as a tool.
- Accessing archived data while maintaining adherence to regulatory guidelines and requirements.
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