Watch Now 16:03
JMP® Clinical: Conducting Medical Safety Reviews of Clinical Trials
Presenter: Chris Kirchberg
About JMP Clinical and How to Add Study Data
The presenter summarizes how JMP Clinical can contribute to efficient medical safety reviews and describes a Nicardipine Hydrochloride (calciium ion influx inhibitor) double-blind clinical study whose data he will use in the demonstration. He shows how to add study data, identify any duplicate information and use the Duplicate Keys Report to verify data integrity and completeness.
Exploring Subjects and Creating AE Narratives
The presenter demonstrates how to compare and update study data; profile subjects; view, add and update data history; and create and share Adverse Event (AE and SAE) narratives and reports.
Performing Safety Reviews and Creating Reports
The presenter looks at lab data and walks through a case study to demonstrates how to review safety-related results. He visually examines the distribution of demographics, Adverse Events and negative effects related to medication. He shows how to customize report settings, create new report templates, view and interpret reports and use JMP to list reports that are unavailable due to missing data. He also shows how to collect and prepare review data in a read-only format that can be shared with those who have JMP Clinical but who have no access to the particular study data.