THE COMMUNITY ARCHIVE

CDISC Papers and PresentationsPage 24

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 461–480

PHUSE · 2020Paper TT07PHUSE US Connect 2020

The Elusive Goal of Automation in SDTM Mapping: A CRO Perspective

Srighar Vijendra; Tyagrajan Swaminathan

Source category: Trends & Technology

Author collections: Tyagrajan Swaminathan

PHUSE · 2020Paper SA04PHUSE EU Connect 2020

The Good? The Bad? Or the Ugly? CDISC eSubmission Packages in Practice

Artur Krupa

Source category: Submissions & Agencies

PHUSE · 2020Paper AD03PHUSE EU Connect 2020

TidyCDISC: An Open-source Application to Interactively Create Tables, Figures and Patient Profiles from ADaM Data

Maya Gans; Nate Mockler

Source category: Application Development

Author collections: Maya Gans · Nate Mockler

PharmaSUG · 2020Paper SS-045PharmaSUG 2020

Updates in SDTM IG V3.3: What Belongs Where – Practical Examples

Lucas Du; William Paget; Lingyun Chen; Todd Case

Source category: Submission Standards

Author collections: Todd Case

PHUSE · 2020Paper TT05PHUSE EU Connect 2020

Using R from End to End: CDISC SDTM and ADaM into .xpt and Output Generation

Antonio Rodríguez Contestí

Source category: Trends & Technology

Author collections: Antonio Rodríguez Contestí

PHUSE · 2020Paper DS12PHUSE US Connect 2020

Using Standardization and Automation to Streamline Generation of DSTM/ADaM Codelists

Eric Du

Source category: Data Standards and Governance

PharmaSUG · 2020Paper SS-081PharmaSUG 2020

Why Are There So Many ADaM Documents, and How Do I Know Which to Use?

Sandra Minjoe

Source category: Submission Standards

Author collections: Sandra Minjoe

PharmaSUG · 2019Paper DS-055PharmaSUG 2019

Achieving Zen: A Journey to ADaM Compliance

Kjersten Offenbecker; Alice Ehmann; Kirsty Lauderdale

Source category: Data Standards

Author collections: Kjersten Offenbecker · Alice Ehmann · Kirsty Lauderdale

PharmaSUG · 2019Paper BP-105PharmaSUG 2019

ADaM 1.1 Compliant ADEVENT and ADTTE development in a Cardiovascular Study

Chao Su

Source category: Programming Techniques

Author collections: Chao Su

PHUSE · 2019Paper AR03PHUSE EU Connect 2019

ADaM-based Centralised Monitoring

Christian Christensen

Source category: Analytics and Risk Based Monitoring

Author collections: Christian Christensen

PharmaSUG · 2019Paper AD-078PharmaSUG 2019

ADME Study PK SDTM/ADaM And Graph

Fan Lin

Source category: Applications Development

Author collections: Fan Lin

PharmaSUG · 2019Paper AD-159PharmaSUG 2019

Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission

Xiangchen (Bob) Cui; Hao Guan; Min Chen; Letan (Cleo) Lin

Source category: Applications Development

Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin

SAS Global Forum · 2019Paper 3790-2019SAS Global Forum 2019

Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission

Xiangchen (Bob) Cui, Hao Guan, Min Chen, and Letan (Cleo) Lin, Alkermes Inc

Source category: Conference presentation

PharmaSUG · 2019Paper BP-182PharmaSUG 2019

Compare and conquer SDTM coding

Phaneendhar Gondesi

Source category: Programming Techniques

Author collections: Phaneendhar Gondesi

PharmaSUG · 2019Paper DS-304PharmaSUG 2019

Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets

Jerry Salyers

Source category: Data Standards

Author collections: Jerry Salyers

PharmaSUG · 2019Paper DS-146PharmaSUG 2019

Considerations when Representing Multiple Subject Enrollments in SDTM

Kristin Kelly; Mike Hamidi

Source category: Data Standards

Author collections: Kristin Kelly

PHUSE · 2019Paper CT15PHUSE US Connect 2019

CT15 Implementing Imputation Rules and Creating Analysis Flags Following CDISC Guidelines

Venkata Madhira; Harish Yeluguri

Source category: Coding Tips & Tricks

Author collections: Venkata Madhira · Harish Yeluguri

SESUG · 2019Paper 281SESUG 2019

Cutting Out the Middle Man – Bypassing ADaM to Calculate Tumor Response Inputs using RECIST 1.1 Guidelines and Collected Data in SDTM Format

Amber Frazier

Source category: E-Posters

File inside source ZIP: E-Posters/SESUG2019_Paper-281_Final_PDF.pdf

Author collections: Amber Frazier

PharmaSUG · 2019Paper AD-208PharmaSUG 2019

Define-XML with ARM

Lei Jing; Chao Wang

Source category: Applications Development

Author collections: Chao Wang

PHUSE · 2019Paper DH03PHUSE US Connect 2019

DH03 From Source Data to SDTM: Enabling a Semi-automated Conversion

Pieter Blomme

Source category: Data Handling