Large-scale TFL Automation for regulated Pharmaceutical trials using CDISC Analysis Results Metatadata (ARM)
Source category: Applications Development
Author collections: Stuart Malcolm
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 26
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 501–520
Leveraging Intermediate Data Sets to Achieve ADaM Traceability
Source category: Data Standards
Author collections: Yun (Julie) Zhuo
More Traceability: Clarity in ADaM Metadata and Beyond
Source category: Data Standards
Author collections: Wayne Zhong · Richann Watson · Daphne Ewing
Next Innovation in Pharma – CDISC data and Machine Learning
Source category: Submission Standards
Author collections: Kevin Lee
Non-Clinical (SEND) Reference Guide for Clinical (SDTM) Programmers
Source category: Submission Standards
Author collections: Dharmendra Tirumalasetti · Bhavin Busa
Pacemaker Guy: De-Mystifying a Business Use Case for SDTM Standard and Medical Device Domains
Source category: Data Standards
Author collections: Carey Smoak · Donna Sattler · Fred Wood
PP02 Streamline Process: To Generate SDTM Programs by Automation
Source category: Poster Presentations
PP05 Medical Device SDTM Domains: A Real Case
Source category: Poster
PP15 Automating the blankcrf.pdf and Define-XML from Your Database Build
Source category: Poster
Author collections: John McDade
PP16 Have You Ever Wanted to Join a CDISC Team?
Source category: Poster Presentations
PP18 PHUSE CDISC Implementation Primer Project Overview and Update
Source category: Poster
Author collections: Beate Hientzsch · Nick De Donder
PP19 Take Advantage of CDISC Standards and Plan Your Study Specifications File
Source category: Poster Presentations
Author collections: Vara Sakampally
PP21 ADaM Programming Made Easy – Common ADaM Templates and an SAS Macro Library
Source category: Poster
Author collections: Niels-Kristian Kjøller
Practical Guidance for ADaM Dataset Specifications and Define.xml
Source category: Submission Standards
Author collections: Jack Shostak
Practical Guide for Creating ADaM Datasets in Cross-over Studies
Source category: Data Standards
Author collections: Neha Sakhawalkar · Kamlesh Patel
Practices in CDISC End-to-End Streamlined Data Processing
Source category: Advanced Programming
Author collections: Chengxin Li
Programmatically mapping source variables to output SDTM variables based upon entries in a standard specifications Excel file
Source category: Programming Techniques
Author collections: Frederick Cieri
RW03 Early Experiences Using SDTM to Organise Clinical Data Collected Using a Physical Activity Tracker
Source category: Real World Evidence
Author collections: Martin Gram · Gianluca Mortari
SA03 ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements
Source category: Submissions and Agencies
Author collections: Marianne Carames
SA10 Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service
Source category: Submissions & Agencies
Author collections: Jesse Anderson · Christopher Bartlett