CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM INC

IN 2024, CDISC INTRODUCED A STRATEGIC ROADMAP TO EXPAND AND ENABLE STANDARDS DRIVEN AUTOMATION ACROSS THE END-TO-END STUDY INFORMATION LIFECYCLE FROM STUDY DESIGN THROUGH RESULTS. CDISC IS MOBILIZING ITS WORK AROUND THREE KEY PILLARS: EXPAND & CONNECT, ENABLE & AUTOMATE, AND ENGAGE & ADOPT POSITIONING CDISC AND THE INDUSTRY FOR FUTURE INNOVATION AND TRANSFORMATION. EXPAND & CONNECT: WE AIM TO EMBRACE AND ADOPT DIGITAL STUDY DESIGN, CREATING CONNECTED STANDARDS ACROSS THE CLINICAL RESEARCH INFORMATION LIFECYCLE WHILE DEFINING A CLEAR PIPELINE FOR INTEGRATING NEW DATA SOURCES. ENABLE & AUTOMATE: WE WILL DEVELOP READY-TO-USE IMPLEMENTATION STANDARDS THAT ARE ENABLED THROUGH TECHNOLOGY, REDUCE VARIABILITY AND FOCUSED ON INTEROPERABILITY AND AUTOMATION TO LOWER THE BARRIER TO STANDARDS USE, AND INCREASING COMMUNICATION TO BETTER ENABLE OUR STAKEHOLDERS.THROUGHOUT 2024, CDISC CONTINUES TO UPDATE NEW VERSIONS OF THE CDISC FOUNDATIONAL AND THERAPEUTIC AREA STANDARDS (SEND, SDTM, SDTMIG, ADAM, CONTROLLED TERMINOLOGY, AND TMF) AS WELL AS HOSTING WORKSHOPS AND HACKATHONS TO FURTHER DEVELOP STANDARDS AND TOOLS TO DRIVE INNOVATION. 2024 TECHNICAL MILESTONES: -INTRODUCED THE ANALYSIS RESULTS STANDARD (ARS) V1.0 TO TACKLE THE INEFFICIENCIES IN GENERATING MACHINE-READABLE ANALYSIS RESULTS. ARS ENABLES AUTOMATION, REPRODUCIBILITY, TRACEABILITY, AND REUSABILITY, TRANSFORMING HOW ANALYSIS RESULTS ARE DESCRIBED, ORGANIZED, AND APPLIED.-LAUNCHED A NEW BIOMEDICAL CONCEPTS (BC) BROWSER TO SIMPLIFY ACCESS TO THE LATEST BCS AND SDTM DATASET SPECIALIZATIONS. THE BROWSER FEATURES SEARCH AND FILTER TOOLS, USER-FRIENDLY VIDEO GUIDES, AND OPTIONS TO DOWNLOAD FILES VIA EXCEL OR RETRIEVE DATA THROUGH CDISC LIBRARY APIS.-RELEASED THE OBSERVATIONAL STUDIES GUIDE V1 TO PROVIDE STRATEGIES FOR USING SDTM WITH OBSERVATIONAL STUDIES AND REAL-WORLD DATA. DEVELOPED COLLABORATIVELY WITH THE DRAGON CONSORTIUM, CJUG, AND GLOBAL INDUSTRY EXPERTS, THE GUIDE HELPS INVESTIGATORS REPRESENT DATA CONCEPTS IN A CDISC-REVIEWED APPROACH.-LAUNCHED THE ETFL PORTAL IN PARTNERSHIP WITH CLYMB CLINICAL PROVIDING READY-TO-USE, ARS-COMPLIANT PACKAGES TO STREAMLINE TFL GENERATION. EACH PACKAGE INCLUDES DISPLAY SHELLS, ADAM DATASETS AND METADATA, ANALYSIS RESULTS METADATA, AND ANALYSIS OUTPUTS, PROMOTING THE ADOPTION OF ARS ACROSS THE INDUSTRY.-INTRODUCED VERSION 2.1 OF STUDY DATA TABULATION MODEL (SDTM) WHICH INCLUDES NEW DATASET AND VARIABLE STANDARDS TO MEET THE NEED FOR DOMAIN MODELS DESCRIBED IN THE TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 (TIG V1.0).-IN COLLABORATION WITH FDA CTP, LAUNCHED FOUNDATIONAL STANDARD FOR COLLECTING, ANALYZING, AND EXCHANGING TOBACCO PRODUCT DATA. THE TIG STANDARDIZES SUBMISSIONS USING CDASH, SDTM, AND ADAM MODELS TO SUPPORT RESEARCH, REVIEW, AND HARM REDUCTION EFFORTS.-INTRODUCED AN OPEN-SOURCE R PACKAGE DESIGNED TO FACILITATE THE CREATION OF STUDY DATA TABULATION MODEL (SDTM) DATASETS. DEVELOPED THROUGH A COLLABORATION AMONG PHARMACEUTICAL COMPANIES AND SPONSORED BY THE CDISC OPEN SOURCE ALLIANCE (COSA), {SDTM.OAK} OFFERS A MODULAR FRAMEWORK WITH REUSABLE ALGORITHMS TO AUTOMATE SDTM DATASET CREATION.-EXPANDED PROTOCOL DIGITALIZATION WITH FULL PROTOCOL COVERAGE IN THE USDM 3 MODEL, ENHANCING DOWNSTREAM CONNECTIVITY, ALIGNING WITH ICH M11, AND EXPLORING THE USE OF THE CDISC OPEN RULE ENGINE FOR USDM CONFORMANCE CHECKS.-INTRODUCED THE ECRF PORTAL, OFFERING READY-TO-USE, CDASH-COMPLIANT ANNOTATED ECRFS IN PDF, HTML, AND XML FORMATS. THESE ECRFS CAN BE USED AS-IS OR IMPORTED INTO EDC SYSTEMS FOR CUSTOMIZATION, PROVIDING FLEXIBLE EXAMPLES FOR DATA COLLECTION.-DEFINE-XML V2.1.7 PACKAGE UPDATED REFLECTING THE RELEASE OF CONTROLLED TERMINOLOGY PACKAGE 58.

EDUCATION - IN 2024 CDISC EDUCATION TRAINED 940 INDIVIDUALS WITH OVER 100 INSTRUCTOR-LED TRAININGS, 30 HOURS OF NEW MATERIALS, IN 20 COUNTRIES WITH 2 NEW TRANSLATIONS. WE DEVELOPED NEW HANDS-ON TRAININGS FOR ARS IMPLEMENTATION, CDISC OPEN RULES IMPLEMENTATION, DATASET-JSON IMPLEMENTATION, ADAM ADVANCED IMPLEMENTATION, AND SDTM ADVANCED IMPLEMENTATION. WE DEVELOPED AND OFFERED NEW VIRTUAL TRAININGS INCLUDING NORD RARE DISEASES, TAUG SDTM MEDICAL DEVICES, TOBACCO IMPLEMENTATION GUIDE V1, AND TMF EXCELLENCE AND A NEW ON-DEMAND COURSE "INTRO TO TMF."