CDISC

CDISC invites you to submit comments during the Public Review for Controlled Terminology Package 59, which consists of the following 17 documents:    • Controlled_Terminology_Requests_Denied_P59 • EG_Codetable_Mapping_P59 PR Version • IS_Codetable_Mapping_P59 PR Version • QRS_Naming_and_Business_Rules_P59 PR Version • Rules for Immunogenicity Specimen Tests_P59 PR Version • Rules for MB and MS_P59 PR Version • Cell Phenotyping* • CV* • Define-XML • General* • Lab* • Microbiology-Immunology* • Oncology* • PK • SEND* • TIG • UNIT   An * indicates that changes or retirements of existing CDISC Submission Values are included on the “Changes to Existing” tab in the document. Please review these changes as there may be submission value changes or term deprecations.   Comments due: 17 January 2025    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. Thank you for contributing your time and expertise. Click here for information and to submit comments: https://lnkd.in/eqWUgH3T #cleardataclearimpact

We are thrilled to share CDISC's 2024 Impact Summary, which celebrates the milestones we've reached and the collective impact of our community. Explore how our commitment to advancing data standards and innovation is transforming clinical data standards and research worldwide. We look forward to your continued support in 2025! Click here to view the CDISC 2024 Impact Summary: https://lnkd.in/gCUkUz99

Join CDISC and Open-Source Developers for Two Webinars In January and Learn How You Can Participate! Register to hear from open-source developers in the CDISC community on how you can get involved and collaborate in these projects as part of the CDISC Open Source Alliance (COSA). Join us for sessions on: OSB-Trail-System Engineers Kick-Off Date: 20 January 2025 Time: 9:00 - 10:00 AM ET Join us for the OpenStudyBuilder Trail System Engineers Kick-Off! We are thrilled to invite you to learn more on our newly launched "OSB-Trail”. This dedicated community brings together system engineers and IT professionals to collaborate on: • Optimizing deployment workflows for OSB across diverse environments • Exploring and implementing robust authentication methods tailored to OSB • Facilitating seamless integrations between OSB and other enterprise systems • Building a network of experts to tackle challenges and share innovative solutions Presenters: Pascal BOUQUET, Founder & Managing Director at HealthtechPartners 42 and Katja Glass, Open Source Ambassador for Pharma Register: https://lnkd.in/g6kG2Bcs {carver} Collaboration and Planning Kick-off Date: 27 January 2025 Time: 8:00 - 9:00 AM ET Join our {carver} team by registering to attend our meeting on 27 January. This meeting is to establish a group of collaborators to work on this project and plan out the next steps. What is {carver}?  • Clinical Analysis Reporting and Visualization Ensemble in R: An open-source (R) package in the COSA repository that aims to help generate common analysis reports – tables, listings, plots and interactive plots – for clinical review and regulatory submissions from ADaM data. • Currently the package contains about 10 common report types (adverse events, demographics etc) which can be generated through templates or interactively in a R Shiny application which is included within it. • Through collaboration with different players, we aim to expand the scope of reports – while it may not be exhaustive – to cover more requirements for submissions. Presenters: Smriti Anand, Senior Statistical Data Scientist at Pfizer Sukalpo Saha, Principal Statistical Data Scientist | R and {shiny} Developer at Pfizer Register: https://lnkd.in/gVzkDNpX Charles Shadle #cleardataclearimpact

3 spots left for CDASH! Registration closes at 9:00am Eastern on 20 December. In January and February 2025, join CDISC-authorized instructors for virtual trainings timed for 9:00am US Eastern Time (15:00 Central European Time). Enroll before the end of the year to lock in the 2024 rate! Learn More: https://lnkd.in/giKWX8gC Instructors: Nancy Brucken Gitte Frausing Marcelina Hungria Rajesh Saha Ward Puttemans Roger GAGALI ANGOH Lisa Dotterweich Mulcahy Dawn Niccum Jennifer Stamper

Reminder: Abstracts for 2025 Europe Interchange Due 17 January! Your CDISC and TMF experience can shape the future, and the CDISC Europe Interchange is the ideal platform for sharing your expertise. Don't wait until the last minute. Submit an abstract of 500 words or less to engage peers and inspire effective strategies for today’s implementers. Your perspective can make a meaningful impact, offering guidance and fresh approaches to benefit the community. 

Call for J3C and C3C Nominations The Japan CDISC Coordinating Committee (J3C) and the China CDISC Coordinating Committee (C3C) are instrumental in bridging the gap between global data standards and regional practices. Being a 3C member provides a unique leadership opportunity that allows appointees from member organizations to contribute to advancing clinical research standards while expanding their professional network and expertise. Do you know someone who exemplifies excellence and leadership in the CDISC community? Nominate them for a spot on the J3C or C3C Coordinating Committees today! Submit your nomination to nominations@cdisc.org by Tuesday, 31 December 2024 to help shape the future of our organization. 

New CDISC QRS Supplements are Available! CDISC has released the following new QRS Supplements. Each published supplement includes an annotated case report form. QRS Supplements to the SDTMIG:  • Observer Global Impression • Kurtzke Expanded Disability Status Scale Supp v1.0 • Symptoms of Major Depressive Disorder Scale Version 1.0 • Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 • Patient-Reported Outcomes Version of the Common Terminology Criteria for • • Adverse Events Item Library Version • Mini-Mental State Examination • Mini-Mental State Examination 2 Standard Version QRS Supplements to the Tobacco Implementation Guide (TIG): • Fagerstrom Test for Cigarette Dependence • Penn State Electronic Cigarette Dependence Index To access new supplements: https://lnkd.in/gvXxmtwu #cleardataclearimpact

The TIG eSubmission Pilot project is a continuation of the collaboration formed to develop the TIG v1.0 with the goal to support adoption and stakeholder realization of efficiencies. This project enables standards adoption and efficiencies through hands-on experience and subject matter expert support. The project duration will be two years and CDISC will engage FDA CTP, tobacco industry subject matter experts, and other relevant stakeholders through project duration.    Join us for an informational webinar on 16 January at 11:00 AM EST with CDISC’s Christine Connolly and the FDA CTP’s Chrissie Cai, where the project scope will be reviewed and information on how you can participate will be shared. Register here to secure your spot: https://lnkd.in/eQGQW3SK   In advance of the webinar, we are accepting submissions for project team volunteers. 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. When submitting the Volunteer Form, select "TIG V1.0 eSubmission Pilot" as the CDISC Standards Development team: https://lnkd.in/gS_6Yd4y   For more information on the project including the scope, visit the project website: https://lnkd.in/e4k3SqP9 #cleardataclearimpact 

CDISC is thrilled to announce the publication of the Cardiac Imaging Supplement v1.0 to the Duchenne Muscular Dystrophy Therapeutic Area User Guide. Developed in partnership with the Critical Path Institute (C-Path) Duchenne Regulatory Science Consortium (D-RSC), the document includes new controlled terminology, and SDTM and ADaM examples for several cardiovascular tests (i.e., basic systolic function, late gadolinium enhancement, parametric mapping and circumferential and longitudinal strain). Access the supplement here: https://lnkd.in/eSvhcuB3 #cleardataclearimpact

  Call for TMF Reference Model Feedback! We are actively collecting feedback to shape the draft of version 4 of the Reference Model. To ensure the success of this initiative, we need the support of the CDISC Community!    Please submit feedback using the link below from now until January 31, 2025. https://lnkd.in/euK3N8XV   When completing the form, please take a moment to reflect on any challenges, limitations, or additional TMF records you’ve encountered that could be valuable for a future version of the TMF Reference Model. We encourage you to share specific examples of improvements that could enhance its overall functionality in TMF Management.    We ask that you use the form to submit one piece of feedback at a time. The form may be submitted as many times as you would like.    A team of TMF experts will carefully review all submitted feedback. Over the next few weeks, results of the feedback will be posted to the CDISC website. Additional communications will be sent out once the results are posted. https://lnkd.in/euK3N8XV