ADME Study PK SDTM/ADaM And Graph
Source category: Applications Development
Author collections: Fan Lin
THE COMMUNITY ARCHIVE
SDTM Papers and PresentationsPage 11
These papers examine the organization of clinical observations into SDTM domains, including mapping, controlled terminology and validation. Examples can help identify implementation questions; requirements may differ across standards versions and submission contexts.
345 papers · Showing 201–220
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission
Source category: Applications Development
Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission
Source category: Conference presentation
Compare and conquer SDTM coding
Source category: Programming Techniques
Author collections: Phaneendhar Gondesi
Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets
Source category: Data Standards
Author collections: Jerry Salyers
Considerations when Representing Multiple Subject Enrollments in SDTM
Source category: Data Standards
Author collections: Kristin Kelly
Cutting Out the Middle Man – Bypassing ADaM to Calculate Tumor Response Inputs using RECIST 1.1 Guidelines and Collected Data in SDTM Format
Source category: E-Posters
File inside source ZIP: E-Posters/SESUG2019_Paper-281_Final_PDF.pdf
Author collections: Amber Frazier
DH03 From Source Data to SDTM: Enabling a Semi-automated Conversion
Source category: Data Handling
DH05 Dynamically Harvesting Study Dates to Construct and QC the Subject Visits (sv) SDTM Domain
Source category: Data Handling
Author collections: Cleopatra DeLeon
DS05 Implementation of SDTM IG v.3.3 for the Neurological Therapeutic Area
Source category: Data Standards and Governance
Author collections: Daryna Khololovych
DS06 Harmonising SDTM at the Source: Two Years Later
Source category: Data Standards and Governance
Author collections: Sue Huxtable
DS07 Considerations when Representing Multiple Subject Enrolments in SDTM
Source category: Data Standards and Governance
Author collections: Kristin Kelly
DS14 Considerations When Representing Multiple Subject Enrollments in SDTM
Source category: Data Standards and Governance
Author collections: Kristin Kelly
Homogenizing Unique and Complex data into Standard SDTM Domains with TAUGs
Source category: Data Standards
Author collections: Sowmya Srinivasa Mukundan · Charumathy Sreeraman
Joining the SDTM and the SUPPxx Datasets
Source category: e-Posters
Author collections: David Franklin
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
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