ABSTRACT
Building a database and preparing a study for production entry of data is building an application. It may not look like programming, but using an application is just like using a high-level programming language, even if there is no “if-then-else” in sight. Because the database application will be used to create records of clinical data, and that data is the basis of decisions on the safety and efficacy of the treatment, and because the data may be used to support a submission to the Food and Drug Administration, a database application for a study falls under Good Clinical Practice (GCP) guidelines and 21 CFR 11 requirements for validation. The Society for Clinical Data Managers (SCDM) also makes a point of this approach in the “Database Validation, Programming and Standards” chapter of their Good Clinical Data Management Practices document.
