Workshop Discusses Evaluating Safety, Quality and Traceability of Submission Data Using JMP Clinical

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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 assessments^2,3.

CDISC standards allow for the development of standardized tools that support safety and data quality review. Recently FDA guidelines^4,5 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:

• CDISC Overview, Regulatory Environment
• CDISC SDTM Models overview and practical implementation examples
• Analysis Results Metadata and practical implementation examples

JMP Clinical: Standardize analysis process and reports:

• JMP Clinical background and usages in regulatory agencies⁶
• Import CDISC data into JMP Clinical software
• Create safety and data quality reports automatically according to clinical trial data
• Follow FDA NDA safety template to understand the drug safety analysis with figures and tables in NDAs and CRs from JMP Clinical reports such as Demographics, Interventions, Events, Findings, Patient Profiles and Narratives⁶
• Explore adverse event reporting strategies such as comparing FMQ (FDA Medical Queries) and SMQ (Standardized Medical Queries)

References

1. FDA Procedures for CDER Medical Officer Conversion to Career-Conditional 2018
2. CDISC Implementation in PMDA 2015
3. EMA Submission of individual patient data from clinical trials
4. FDA Standard Safety Tables and Figures: Integrated Guide   
5. CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation. Geoffrey Mann, Thomas J. Pedersen, Rebecca Lyzinski, Anisa Scott, John Cromer, Meichen Dong, Andrew J Foglia, Nora Varga, Sam Gardner, Christopher J. Kirchberg, Byron A. Wingerd, Russell D. Wolfinger*, Wenjun Bao*. Journal of the Society for Clinical Data Management.  Manuscript is accepted.