CDISC SDTM IG v3.4: Subject Visits
Source category: Data Standards
Author collections: Ajay Gupta
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 15
Browse practical discussions of clinical data standards, from collected observations to analysis datasets and supporting metadata. Use the more focused ADaM, SDTM and Define-XML collections to follow a particular stage of the workflow.
856 papers · Showing 281–300
CDISC’s ADTTE Domain: Time-to-Event Analysis From a Programmer’s Point of View
Source category: Poster Presentations
Author collections: Vitali Gering
COSA Updates – The Latest From the CDISC Open-Source Alliance
Source category: Poster Presentations
Author collections: Sam Hume
Demystifying the define.xml: Overcoming the challenges of CRT Package.
Source category: Pharma and Healthcare
Author collections: Yoganand Budumuru
Developing and Implementing CDISC CORE Rules: From Zero to Hero
Source category: Standards Implementation
Author collections: Marisa Wyckmans
DIY: Building a Raw Metadata Library with Integrated SDTM Annotations
Source category: Poster Presentation
Author collections: Sanjiv Ramalingam
EDC Raw Data to SDTM Curation, Mapping and Automation with XBiom Tool
Source category: Software Demonstrations
Author collections: Sunil Gupta
Empowering Paediatric Drug Development: CDISC Standards and ICH Guidelines for Clinical Trials with Little Participants
Source category: Data Standards & Governance
Enhancing the Quality of Data Harmonisation – a Customisable Tool for Validation of Bespoke SDTM Implementation at the Infectious Diseases Data Observatory (IDDO)
Source category: Poster Presentations
Author collections: Sadie Kelly
Exploring the Possibility of Automating SDTM Domain Subject Visits (SV)
Source category: Scripts & Snippets
Author collections: Limna Salim
FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion
Source category: FDA Wednesday
Author collections: Helena Sviglin
For Clinical Trials: A Faster and Smoother Approach to Create your SDTM and ADAM Define Specifications for Define.xml with SAS®
Source category: Industry Applications
From FDA to PMDA submission: How to resolve CDISC non-compliance issues
Source category: Submission Standards
Gear Up SDTM with Digital Health Devices
Source category: Standards Implementation
Author collections: Vicky Poulsen
Guidance on SDTM for Liquid Oncology Endpoints
Source category: Poster Presentations
Author collections: Tyagrajan Swaminathan
Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance
Source category: Submission Standards
Author collections: Pragathi Mudundi · Zhaoyu Xie
Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship
Source category: Data Standards
Author collections: Richann Watson
ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality
Source category: Data Standards & Governance
Author collections: Peter Van Reusel
Implementation of a MedDRA Upgrade in SDTM: A SAS-based Approach
Source category: Coding Tips & Tricks
Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies
Source category: Data Standards
Author collections: Xiangchen Cui