CDISC

Join Bess LeRoy and Bhavin Busa on 12 December at 11AM EST to learn more about the CDISC eTFL Portal, launched in partnership with Clymb Clinical! The eTFL Portal contains ready-to-use, Analysis Results Standard (ARS)-compliant packages to help streamline TFL generation and marks the next step in promoting the utilization of ARS across the industry. Register here:  https://lnkd.in/gfpApgSK #cleardataclearimpact

Call for Project Team Volunteers! A multidisciplinary team, including members from CTP, industry, and CDISC, is responsible for all project tasks, including establishing a framework for ongoing TIG v1.0 standards collaboration and refinement post-project. This team will support all participants and continue beyond project completion to advance TIG standards. Participation Requirements: • Industry members must actively adopt TIG v1.0 standards within their organizations during the project. • CTP and industry team members must complete the TIG online education curriculum at the project’s start. Project Structure: The project team, operating as a full team and through two workstreams, will meet monthly to review strategy, progress, and findings, with additional weekly workstream meetings (up to one hour, plus two hours of prep). Workstreams: Education Workstream - Open to all adopters to strengthen CTP and industry knowledge and adoption of TIG v1.0 through focused educational content. Simulated eSubmission Workstream - Up to nine applicant organizations will apply TIG v1.0 standards in project-specific eSubmissions to CTP. When submitting Volunteer Form, select "TIG V1.0 eSubmission Pilot" as the CDISC Standards Development team. Submit Your Interest Form: https://lnkd.in/gS_6Yd4y

Follow the new Tobacco Implementation Guide (TIG) LinkedIn Page for the latest insights, resources, and updates to help you support the use of the Tobacco Implementation Guide (TIG). We’re here to keep you informed on best practices for TIG adoption, educational resources, and key projects advancing regulatory and research efficiency in the tobacco sector. https://lnkd.in/etbjHvna #cleardataclearimpact

A huge thank you to all the participants, presenters, sponsors, and the K3C team who helped make the 2024 CDISC Korea Interchange a success! Your engagement, expertise, and support were instrumental in fostering meaningful discussions and advancing our shared goal of enhancing global clinical research through data standards. We are grateful for your contributions and look forward to continued collaboration in the future! #cleardataclearimpact #cdisc2024korea Gihwan Kim, ByeongKwan Park , @Im Hee Shin, @Jamie Lee, Eunhye Lee

ICH M11 Clinical Electronic Structure Harmonised Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality by Peter Van Reusel ( CDISC ) at final day of PHUSE EU 2024. Followed by David Iberson-Hurst - Partner at d4k ( practical electronic study designs) and Mikkel Traun (multi stakeholder collaboration) all within an excellent Digital Data Flow ( DDF ) stream. We have been talking about eProtocol for years but now is the moment to jump on the 🚆 and drive the change in our industry. 🚀 It is clear it will have a huge impact … change management will be top priority ; internal and external partnering for success 🤝

Call for CDISC and TMF Abstracts Open Through 17 January! Your CDISC and TMF experience can shape the future, and the CDISC Europe Interchange is the ideal platform for sharing your expertise. Submit an abstract of 500 words or less to engage peers and inspire effective strategies for today’s implementers, ultimately enhancing patient outcomes. Your perspective can make a meaningful impact, offering guidance and fresh approaches to benefit the community. SUGGESTED CDISC TOPICS • New Data Sources (e.g., RWD/RWE, EHR, DHTs) • Digital Design (i.e., Digital Data Flow, USDM) • CDISC Foundational Standards • Innovation in Clinical Trials and CDISC Standards • Open Source Usage, Including CORE, OAK, ARS, COSMoS • CDISC in Academic Research • Global Regulatory Submissions • CDISC 360i End-to-End Adoption • Analysis Results Standards (ARS) Submit a CDISC Abstract: https://lnkd.in/exzxwKXn SUGGESTED TMF TOPICS • Version 4: TMF RM Becoming a Standard to Support a Digital TMF • TMF Reference Model as a Tool • Impact of Regulations • Technology and Innovation in TMF Management • Risk-Based Approaches • TMF Interoperability • TMF Culture and Engagement • CRO / Vendor Relationships • Inspections and Audits • Investigator Site Documents • End of Study Challenges Submit a TMF Abstract: https://lnkd.in/exzxwKXn #cleardataclearimpact

We invite you to submit comments through 12 December on the following QRS supplements to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials during Public Review: • Richmond Agitation-Sedation Scale (RASS) • Perianal Crohn’s Disease Activity Index (PDAI) • Geriatric Depression Scale Short Form (GDS SHORT FORM) Supp V2.0 • Sepsis-related Organ Failure Assessment 27MAR2024 (SOFA 27MAR2024) Score   For more information and to provide comments: https://lnkd.in/e7nejXHc   Public Review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research.   #cleardataclearimpact

Join CDISC and partner, TransCelerate BioPharma Inc. for the second webinar in the DDF Solution Showcase series on December 5! Register here: https://lnkd.in/eZpHe-jN #cleardataclearimpact

2024 CDISC KOREA INTERCHANGE Day 2 Korean participants are very interested in the approval of clinical trials by overseas regulatory agencies. In the first session, there were many questions about FDA, PMDA, and moxibustion. There was also an announcement from the Ministry of Food and Drug Safety in Korea. Now, CDISC's interest is growing in Korea. The conference room is hot with the concentration of participants. Clupea’s MediLake platform is supporting clinical trials with the cdisc standardization platform. Clupea is excited to participate in the 2024 CDISC KOREA INTERCHANGE. We look forward to discussing the cdisc platform with many participants. #cdisc2024Korea #MediLake #clupeainc

2024 KOREA CDISC Intetchage day1,2가 순조롭게 잘 진행되고 있습니다. 많은 분들이 참여해주셔서 감사드리고 앞으로 국내에서 cdisc의 저변이 계속 확대될수 있는 계기가 되면 좋겠습니다. 후원해주신 LSK Global PS, clupea, HK innoN, Certara, J&P medi , CRS cube에 감사드립니다.