An FDA Submission Experience Using the CDISC Standards
Source category: Regulatory
Author collections: Angelo Tinazzi · Cedric Marchand
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 34
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 661–680
Analysis Results Metadata 1.0 for Define-XML 2.0 - Benefits to Statistical Analysis
Source category: Standards Implementation
Author collections: Lionel Debecq
Automate Validation of CDISC SDTM with SAS®
Source category: Conference presentation
Automatic Creation of Define .xml for ADaM: A Fast Way Approach, Starting from ADaM Metadata
Source category: Posters
Author collections: Dmitri Petratchenko
Automatically Map CDASH Data to the Study Data Tabulation Model (SDTM) Structure
Source category: Conference presentation
Basic SDTM House-Keeping
Source category: Quick Tips
Author collections: Emmy Pahmer
Bridging the Gap Between Legacy and CDISC Standards
Source category: Standards Implementation
The publisher-listed Slides file is currently unavailable.
Author collections: Bill Qubeck
Building a Fast Track for CDISC: Practical Ways to Support Consistent, Fast and Efficient SDTM Delivery
Source category: Industry Basics
Author collections: Steve Kirby · Mario Widel · Richard Addy
CDISC Compliant NCA PK Parameter Analysis When Using Phoenix® WinNonlin®
Source category: Posters
CDISC Transport Standards - A Glance
Source category: Data Standards & Governance
Author collections: EDWIN PONRAJ THANGARAJAN · Giri Balasubramanian
Challenges and Solutions for Handling Re-screened Subjects in SDTM
Source category: Building Blocks
File inside source ZIP: Building_Blocks/SESUG2017_Paper-223_Final_PDF.pdf
Author collections: Charity Quick
Clarifications About ADaM Implementation Provided in ADaMIG Version 1.1
Source category: Data Standards
Author collections: John Troxell
Clinical Metadata - Web-based metadata management with a CDISC mindset
Source category: Standards Implementation
Common Programming Errors in CDISC data
Source category: Data Standards
Author collections: Sergiy Sirichenko
Considerations and Conventions in the Submission of the SDTM Tumor and Response Domain
Source category: Data Standards & Governance
Author collections: Jerry Salyers · Fred Wood
Conversion of CDISC specifications to CDISC data – specifications driven SAS programming for CDISC data mapping
Source category: Data Integrity
Author collections: Yurong Dai · Jameson Cai
Converting Legacy Data to "ADaM-like" Data for Making Efficient Regulatory Response
Source category: Data Handling
The publisher-listed Slides file is currently unavailable.
Converting Non-Imputed Dates for SDTM Data Sets With PROC FCMP
Source category: Techniques & Tutorials
Author collections: Noory Kim
Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
Source category: Submission Standards
Author collections: Lex Jansen
Data Integrity: One step before SDTM
Source category: Data Integrity