07. Development of a Visual Interface Report with Writeback Functionality to Assist Data Cleaning Process

Clinical investigations are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects. The quality of clinical trial data is critical to the protection of human subjects and the conduct of clinical studies under the ISO and FDA guidance. Data cleaning is a crucial part to ensure data integrity, and successful data analyses and data interpretations cannot be achieved without it. A well-established data cleaning process usually involves collaborations between multiple functional teams. To enable more efficient cross-functional collaborations on the data query report, we developed a graphical user interface with writeback functionality that enables the end users to provide their feedback directly into the report, with data refreshed automatically on a regular basis. This visual interface provides the latest insights on data cleaning progress, and the writeback function facilitates efficient communication between Clinical Monitoring and Data Management. This process shortens the study timelines by allowing teams to proactively clean data prior to database locks while ensuring data integrity.

Study Design and Data Management

Effective Communication

Visual Interface

Data Integrity