Therapeutic Area Standards and their Impact on Current SDTM Implementations
Source category: CDISC and Industry Standards
Author collections: Johannes Ulander · Niels Both
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 42
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 821–840
Tips on Creating a Strategy for a CDISC Submission
Source category: Industry Basics
Two different use cases to obtain best responses using RECIST 1.1: SDTM and ADaM
Source category: Industry Basics
Author collections: Kevin Lee · Vikash Jain
Usage of OpenCDISC Community Toolset 2.0 for Clinical Programmers
Source category: Hands-On Training
Author collections: Sergiy Sirichenko · Michael Digiantomasso · Travis Collopy
Using SAS® Clinical Data Integration to Roundtrip a Complete Study Study Metadata (Define-XML) and Study Data (Dataset-XML)
Source category: Submission Standards
What is the “ADAM OTHER” Class of Datasets, and When Should it be Used?
Source category: Data Standards
Author collections: John Troxell
A Guide to the ADaM Basic Data Structure for Dataset Designers
Source category: Data Standards
Author collections: Michelle Barrick · John Troxell
A Road Map to Successful CDISC ADaM Submission to FDA: Guidelines, Best Practices & Case Studies
Source category: Data Standards
Author collections: Vikash Jain · Sandra Minjoe
A Toolkit to Check Dictionary Terms in SDTM
Source category: Coders Corner
Author collections: Huei-Ling Chen · Helen Wang
Adopted Changes for SDTMIG v3.1.3 and 2013 OpenCDISC Upgrades
Source category: Posters
Author collections: Yi Liu Celerion Inc. · Stephen Read Celerion Inc.
An ADaM Interim Dataset for Time-to-Event Analysis Needs
Source category: Data Standards
Author collections: Tom Santopoli · Kim Minkalis · Sandra Minjoe
An Alternative Way to Create Define.XML for ADaM with SAS Macro Automation
Source category: Data Standards
Applying ADaM BDS Standards to Therapeutic Area Ophthalmology
Source category: Data Standards
Author collections: Songhui Zhu
Automation of ADAM Dataset Creation with a Retrospective, Prospective and Pragmatic Process
Source category: Posters
Author collections: Karin LaPann · Terek Peterson
CDISC Electronic Submission
Source category: Data Standards
Author collections: Kevin Lee
CDISC Mapping and Supplemental Qualifiers
Source category: Posters
Author collections: Arun Raj Vidhyadharan · Sunil Mohan Jairath
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS
Source category: Data Standards
Author collections: Karin LaPann · Terek Peterson
Considerations in Creating SDTM Trial Design Datasets
Source category: Data Standards
Author collections: Jerry Salyers · Richard Lewis · Kim Minkalis · Fred Wood
Considerations in the Submission of Exposure Data in SDTM-Based Datasets
Source category: Data Standards
Author collections: Fred Wood · Jerry Salyers · Richard Lewis · Kristin Kelly
Creating Define-XML version 2 with the SAS® Clinical Standards Toolkit 1.6
Source category: Data Standards
Author collections: Lex Jansen