Challenges in Implementing Device Related ADaM and SDTM Standards in a Drug-Device Study
Source category: Medical Devices
Author collections: Wenying Tian · Karin LaPann
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 30
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 581–600
Common Define.xml File Issues Seen During FDA’s JumpStart Service
Source category: Poster Presentations
Author collections: MARGO COHEN
Compare Pharmacokinetic Data Submission Processes in CDISC Environment
Source category: Application Development
Author collections: Xiaopeng Li · Shallabh Mehta
Complexity in collection of PGx data and challenges in mapping to SDTM
Source category: Data Standards
Author collections: Rama Kudaravalli
Complying with the ADaM Compliance Rules
Source category: Data Standards
Author collections: Steven Kirby
Conversion of CDISC Specifications to CDISC Data – Specifications Driven SAS® Programming for CDISC Data Mapping
Source category: SAS 301 Beyond the Basics
Author collections: Yurong Dai
Core and Extension studies – Challenges and solutions towards SDTM submission
Source category: Data Standards
Author collections: Murali Marneni
Cost-Benefit Analysis of Using CDISC Standards in Trial Set-up
Source category: Data Standards & Governance
The publisher-listed Slides file is currently unavailable.
Author collections: Jasmine Kestemont
Creating an ADaM Data Set for Correlation Analyses
Source category: Data Standards
Author collections: Chad Melson
Cross-study Analysis of SDTM Data Using R
Source category: Data Handling
Crowdsourced ADaM Programming and Standardisation: A Design Study
Source category: Trends & Technology
Author collections: Holger Langkabel
Data Management and CDISC Formatting for Transdermal Patches
Source category: Medical Devices
Author collections: Lois Lynn
Define-XML Value-level Metadata Coding and Naming Guidance
Source category: Coding Tips & Tricks
Define-XML-centric Dataset Development
Source category: Standards Implementation
define.xml (noun): Fear Inducing Task for SAS Programmers
Source category: Submission Standards
Author collections: Kjersten Offenbecker · Antonio Cardozo · Kirsty Lauderdale
Derivations of Response Status from SDTM Domains using RECIST 1.1
Source category: Application Development
Author collections: Christine Teng
Diagnostics of Technical Errors in Define-XML File
Source category: Standards Implementation
Author collections: Sergiy Sirichenko
Diagnostics of technical errors in define.xml file
Source category: Submission Standards
Author collections: Sergiy Sirichenko
Doctor’s ‘Prescription’ to Reengineer Process of Pinnacle21 Community Version Friendly ADaM Developm
Source category: Data Standards
Author collections: Aakar Shah · Tracy Sherman
Dos and Don'ts of Define-XML
Source category: Submissions & Agencies