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CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC's Open Rules Engine (CORE)

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC's Open Rules Engine (CORE)
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Peter Van Reusel , Melissa Kirwin , Lilliam Rosario , Office Of Translational Sciences , Drug Administration Office Of Translational Sciences , Office Of Regulatory Operations , Clinical Data Interchange Standards Consortium , Office Of Computational Science , Drug Administration , Translational Sciences , Drug Evaluation , Regulatory Operations , Biologics Evaluation , Rules Engine , Conformance Rules , Chief Standards Officer , Computational Science , Data Interchange Standards Consortium ,

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC's Open Rules Engine (CORE)

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC's Open Rules Engine (CORE)
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Lilliam Rosario , Peter Van Reusel , Office Of Translational Sciences , Office Of Computational Science , Office Of Regulatory Operations , Drug Administration Office Of Translational Sciences , Clinical Data Interchange Standards Consortium , Research Collaboration , Rules Engine , Drug Administration , Translational Sciences , Drug Evaluation , Regulatory Operations , Biologics Evaluation , Conformance Rules , Chief Standards Officer , Computational Science , Data Interchange Standards Consortium ,

The CDISC Open Rules Engine (CORE) Open-Source Software For Clinical

Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover. ....

Sam Hume , Standards Development , Clinical Research Community , Resource Alliance , Source Technology , Open Source Technology , Rules Engine , Conformance Rules , Rule Editor , Foundational Standard , Foundational Standards , Minimal Viable Product , Clinical Research , Conformance Rule , Smart Submission Dataset Viewer , Standard Conformance Rules ,

CDISC Teams Up with Microsoft to Develop Open-Source Software for the Clinical Research Community

CDISC Teams Up with Microsoft to Develop Open-Source Software for the Clinical Research Community
CDISC is teaming up with Microsoft to develop the CDISC Open Rules Engine (CORE), open-source software that executes machine-readable CDISC Conformance Rules. The global clinical research community will be able to leverage the CORE software to test study data for conformance to CDISC standards as well as regulatory and sponsor-specific conformance rule sets.
CDISC Conformance Rules as well as regulatory agency rules provide a critical quality check in ensuring study data conform to CDISC standards. An emerging industry best practice is to use Conformance Rules on an ongoing basis, throughout the study, to keep the data as close to submission ready as possible and to ensure quality in all data exchange scenarios. The free and open, Microsoft Azure-based CORE will execute Conformance Rules retrieved from the CDISC Library against standardized clinical research data and produce ....

United States , Sam Hume , Annp White , Patty Obermaier , China National Medical Products Administration , Resource Alliance , Life Sciences , Drug Administration , Devices Agency , Japan Pharmaceuticals , Rules Engine , Conformance Rules , Microsoft Azure Based , Source Rules Engine , Pharma Industry , United States Food , Medical Devices Agency , ஒன்றுபட்டது மாநிலங்களில் , சாம் ஹியூம் , வாழ்க்கை அறிவியல் , ஜப்பான் மருந்துகள் , விதிகள் இயந்திரம் , மைக்ரோசாஃப்ட் நீலமான அடிப்படையிலானது , பார்மா தொழில் , ஒன்றுபட்டது மாநிலங்களில் உணவு ,