SD01 DR3 – A Tool to Create Define-XML (SDTM/ADaM with ARM)
Source category: Software Demonstrations
Author collections: Eric Weising
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 27
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 521–540
SDTM Validation Tool
Source category: Data Handling
SI01 End-to-End SDTM Automation: A Metadata-centric Approach
Source category: Standards Implementation
Author collections: Roman Radelicki · Swapna Pothula
SI01 How Will You Use CDISC Library?
Source category: Standards Implementation
SI02 Creating the Virologic Response ADaM Dataset
Source category: Standards Implementation
SI02 Implementing the CDISC Library API in Software Applications: First Experiences
Source category: Standards Implementation
Author collections: Jozef Aerts
SI04 Creation of Define-XML v2.0 Using SAS Program and Pinnacle 21
Source category: Standards Implementation
SI04 Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit
Source category: Standards Implementation
SI05 Fake it Till You Make it with Global SDTM Laboratory Submissions
Source category: Standards Implementation
Author collections: Éanna Kiely
SI05 Using Pinnacle 21 Enterprise for Define-XML Creation: Tips and Tricks from a CRO Perspective
Source category: Standards Implementation
Author collections: Franklin Menius
SI06 End-to-end SDTM Automation: A Metadata-centric Approach (winner)
Source category: Standards Implementation
Author collections: Roman Radelicki
SI07 Have You Met Define-XML v2.0?
Source category: Standards Implementation
Author collections: Christine McNichol
SI07 How to Use SUPPQUAL for Specifying Natural Key Variables in Define-XML?
Source category: Standards Implementation
Author collections: Sergiy Sirichenko
SI08 Considerations for Using CDISC Standards in Observational Studies
Source category: Standards Implementation
SI09 Choosing the Right Path to Follow When Integrating ADaM
Source category: Standards Implementation
Author collections: Laura Phelan
SI10 CDISC in Phase I/II Studies: Case Studies in Adopting Standards
Source category: Standards Implementation
Author collections: Emily Woolley
SI12 CDISC Rules + FDA Requests + PMDA Requirements = Guaranteed Compliance?
Source category: Standards Implementation
Author collections: Deborah Goodfellow · Mario Widel
The Trials and Tribulations of Automated SDTM Delivery
Source category: Application Development
This Paper focuses on CDISC Questionnaires, Ratings and Scales (QRS) supplements and types of FDA Clinical Outcome Assessments
Source category: Data Standards
Timing is Everything: Defining ADaM Period, Subperiod and Phase
Source category: Data Standards
Author collections: Nancy Brucken