Basic

Using JMP Clinical 17 for Medical Monitoring and Subject-Level Reviews in Clinical Trials

Application Area:
Life Sciences

One of the most significant roles of the Medical Monitor is conducting safety data reviews to evaluate the presence or lack of safety issues with respect to the treatment the subjects receive. Reviews are conducted throughout the study, from Phase 1 through Phase 4. Not only are reviews required by regulators, but they are necessary to ensure the safety of participants. By following subjects as they progress through the study, researchers can build a picture of the safety profile of the compound under consideration. See an example of how Medical Monitors can use JMP Clinical to discover and understand the causes of adverse safety events in a clinical trial using several JMP Clinical 17 study-level and subject-level data views.

This session covers: registering a study; adding and running reports related to adverse events; showing patient profiles; reporting time trends for findings; showing study flow diagrams, examining distributions on patient populations, exploring SQM/FMQ risk reporting and finding Hy’s law candidates.