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• Octagon Research Solutions– A development partnering organization that offers regulatory,
clinical, process and IT solutions to the life sciences industry.
• Octagon experience on topic:– 600 studies converted to SDTM & ADaM (8,000+ domains)– Current CDISC SDS team lead– 2 of 6 co-authors of CDISC SDTM– Current CDISC team membership: SDS, ADaM, Trial
Design, Controlled Terminology, and XML– CDISC-authorized SDTM trainers
• Acknowledging the fears– Inhibiting scientific innovation– Perception of standards governance as bureaucracy– Business needs compete with standards needs– Unacceptable cost in time and resources– The standards will not be stable
• Numbers– Varies from company to company– Part-time resources far outnumber the full-time ones
• Full-time– Team leader(s)– Decision-makers (content & structure)
• Part-time– Oncology physician for RECIST tumor measurements– EDC screen developer including monitoring needs in eCRF– Statistical programmer writing standard macro code– IT rep as liaison - governance group to IT project managers
• What are Standards ????– A company’s methodology in a stable format– Intellectual property in some cases– Internal vs external– Reusable pieces used in clinical trials
• Data definition files• eCRF screens• EDC data extracts• Data checking utilities/programs• Macros for standard results• Analysis dataset programs• XML transfer files
• SDTM implementation considerations– SDTM Findings class in collection: horizontal vs vertical– SDTM mapping: stability of standard CRFs– Best location in the data lifecycle for conversion to SDTM– SDTM experience in the EDC functional area – Linear implementation: CDASH to SDTM to ADaM– Which databases house data needed to build Trial Design? – SDTM & ADaM metadata – Define.xml: How? Who?– SDTM training: Who? What? When?
• Standard Operating Procedures (SOPs)– Development of standards– Maintenance of standards– Request process for new or revised standards– Role of the data steward in governance– Access control for standards storage – Waiver process
• Standards Request System– The face of the standards governance framework – Allow study teams to submit standards requests– Allow for supportive files – Assign unique identification number – Track requests by date, resolution, user, etc.– Fulfill request with discussions, questions, and
decisions– Provide users with status of their requests– Provide reporting capabilities (metrics, etc.)
• Clinical Data Repository– Repose all data in standard centralized location– Import, storage, and export of data in SDTM– Validated inbound ETL process – Promote standardized, validated data import and
export– Support the production of analysis datasets and
clinical study reports– Interoperability with clinical systems across the