CDISC

Tobacco Implementation Guide (TIG) On-Demand trainings are now available! Participants will learn to navigate and apply the SEND, CDASH, SDTM, and ADaM models, relate them to the CDISC Tobacco Implementation Guide (TIG), interpret examples from the TIG, design data representations for TIG-related studies, and integrate Controlled Terminology (CT) into their data. Learn More: https://lnkd.in/gfxzUndA

Join CDISC for the following brand new, 4-hour hands-on implementation training sessions at the upcoming CDISC + TMF Interchange in Scottsdale, Arizona!  - Dataset-JSON Hands-on Implementation Training  - ARS Hands-on Implementation Training  - CORE Hands-on Implementation Training Enroll: https://lnkd.in/gRr-XJ5Q

ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology Austin, Texas, USA and Geneva, Switzerland - The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical specification to ensure clinical study protocols are prepared in a consistent manner and provided to users in a harmonised data exchange format acceptable to all regulatory authorities of the ICH regions. This protocol and electronic exchange format will facilitate the streamlining and exchange of protocol information and support future tool development. ICH and CDISC (Clinical Data Interchange Standards Consortium) have signed a Memorandum of Understanding (MOU) collaborating to support the maintenance and governance of ICH M11 controlled terminology. This collaboration focuses on the use of CDISC’s unified governance process and terminology services for the long-term support of ICH M11 controlled terminologies and focuses on the curation and maintenance of these controlled terminologies. Specific responsibilities include following the robust CDISC standards development process for public review, publication and ensuring they are freely available to all and that the process is transparent for the public. “CDISC is thrilled to partner with ICH on this protocol initiative towards the establishment and maintenance of controlled terminology for a future digital protocol where study design information is driving better research and review of products.” said Chris Decker, CDISC President and CEO. ICH and CDISC will support these goals and align activities to support the development, adoption, and implementation of these controlled terminologies. Read the full press release here: https://lnkd.in/g2DHit3m

Early Bird Ends Friday, 23 August! CDISC is headed to the Western United States for its flagship US Interchange! Join us in sunny Scottsdale, Arizona for innovative presentations, networking opportunities, and interactive training and workshops. This year’s conference features an expanded 5-track agenda with 30+ sessions for two days of cutting-edge insights and innovations shaping the future of CDISC clinical data standards and the Trial Master File. Registration is open! https://lnkd.in/ejKy_Gqz

Read the latest on the Task Force within the CDISC Advisory Council (CAC) and how their efforts mark a significant enhancement in stakeholder engagement, providing a valuable forum for early input and acceptance of proposed standards. The Task Force's evaluation of the proposed changes to the Study Data Tabulation Model Implementation Guide (SDTMIG) 4.0 underscores the importance of this early engagement. #cleardataclearimpact

Program Announced for the US+TMF Interchange! This year's US Interchange, happening 23-24 October in beautiful Scottsdale, AZ, brings CDISC Standards content and TMF presentations to the podium from an impressive lineup of subject matter experts who will delve into the latest trends and innovations. The program provides a versatile experience, allowing attendees to focus on specialized topics, mix subjects, and participate in standards-related workshops. View the online program now!  https://lnkd.in/gnByUH52

Join CDISC's Chris Decker and industry partners for tomorrow's webinar, "Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value". Register here: https://lnkd.in/e3DH68xU

We are thrilled to feature Deborah Shepard, Ph.D., in our Volunteer Spotlight, celebrating her commitment as a crucial part of the Genomics Subteam since May 2022! Deborah advises new CDISC volunteers to "be open to learn from other team members and to share your knowledge and experience. You’ll be amazed at the synergy that takes place when we bring our ideas together. I learn something new in every meeting and appreciate the opportunity to advance data standards for the larger community".

Looking forward to participating in this joint collaborative webinar with TransCelerate BioPharma Inc., CDISC, and HL7 Vulcan on how we are moving digital protocol forward!

Last Call For China Interchange Abstracts Don't miss the 14 June deadline! Your experience, research and ideas can help shape the future — and CDISC’s China Interchange provides the perfect platform for sharing your expertise. With an abstract of 500 words or less, you can increase your exposure and recognition across the Chinese and global standards community, while providing valuable information that can help today’s implementers make more informed decisions that impact patient outcomes. Start now, with just one paragraph on: - Novelty in Clinical Trials - Real-world Data / Evidence - CDISC in Academic Research - Open Source Usage - Digital Data Flow - Global Regulatory Submissions The China Call for Abstracts will close end of day Friday, 14 June. Please visit the Abstract Submission Page for the complete list of suggested topics, instructions, and the online form. https://lnkd.in/eANF-kR9