CDISC and JMP will host a joint workshop at the CDISC Europe Interchange. The "Evaluating Safety, Quality and Traceability of Submission Data Using JMP Clinical" session is an exciting collaboration that will focus on practical implementation of CDISC standards and their application in JMP Clinical. It will demonstrate how JMP Clinical can be used to create reports that follow the new draft regulatory guidelines.
The workshop, 25 April, 1-5 p.m. CET, will feature Wenjun Bao (@Wenjun_Bao_JMP) and Geoffrey Mann (@geoffrey_mann) of JMP and CDISC speakers Rhonda Facile, Sam Hume, and Bess LeRoy.
The session will convert common clinical concepts (e.g., Adverse events and Demographics) to CDISC format and transform the data into clinical trial drug safety, efficacy, and data quality reports, and show how traceability is effectively maintained through the submission data sets.
CDISC standards are required for submissions by the US FDA and Japan PMDA, recommended by the China NMPA, Europe EMA, and adopted by the world’s leading research organizations. FDA mandates CDISC and JMP Clinical Training for new FDA reviewers and reviewers’ career advancement1. PMDA and EMA publicly acknowledge their usage of JMP Clinical for their clinical trial assessments2,3.
CDISC standards allow for the development of standardized tools that support safety and data quality review. Recently FDA guidelines4,5 have been developed to provide more structure and standardization for safety and efficacy reports that can be generated using JMP Clinical.
Workshop Agenda
CDISC: Standardize data format and requirements:
JMP Clinical: Standardize analysis process and reports:
References
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