What does the term "data lock" mean in clinical research?

The term "data lock" in clinical research refers to the process of finalizing the database and ensuring that no changes can be made prior to analysis. This step is crucial for maintaining the integrity and validity of the data collected during a clinical study.

Once the data lock occurs, the database is considered stable, and all data entries, modifications, or corrections are accounted for before any statistical analysis is performed. This process helps to prevent errors, ensures that the data is complete and accurate, and enhances the reliability of the study’s findings. By locking the data, researchers can confidently move forward with the analysis, knowing that the data they are analyzing reflects the agreed-upon and validated dataset.

The other options do not accurately reflect the concept of data lock. Collecting additional data or considering the moment the study concludes does not pertain to the integrity and finality of the database. Similarly, a technique to speed up data entry is unrelated, as data lock focuses on stabilizing the data rather than expediting data management processes.