Intentional re-challenge, a practice within clinical data management, is a deliberate and controlled re-administration of a drug to a patient who has previously experienced an adverse drug reaction or drug-related problem during the course of a clinical trial. This process is undertaken to confirm the causality between the drug and the observed adverse event, gain a deeper understanding of the event's mechanisms, and assess the potential for its recurrence. Clinical data management plays a pivotal role in documenting and tracking these intentional re-challenges, meticulously recording patient information, medical history, dosage regimens, and the nature and severity of the adverse event. The data management process ensures that the re-challenge is conducted in a controlled and ethical manner, with a keen focus on patient safety. This comprehensive data management approach aids in evaluating the drug's safety profile, informing regulatory decisions, and ultimately contributing to the overall pharmacovigilance and risk assessment of the drug under investigation.