Software Development Life Cycle

The success of any clinical study depends on the quality and integrity of its data. Effectively managing the Software Development Life Cycle (SDLC) of computerized systems utilized in clinical studies is crucial and involves risk-based processes for ensuring that data are of high quality and integrity. This chapter discusses the life cycle of various software types (in-house, vendor-licensed, open-source) from validation through decommissioning. Principles for study-specific customization, use of real-world data, and risk-based considerations for software development will also be discussed.