THE COMMUNITY ARCHIVE

CDISC Papers and PresentationsPage 36

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 701–720

PharmaSUG · 2017Paper DS13PharmaSUG 2017

Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database

Cori Kramer; Ragini Hari; Keith Shusterman

Source category: Data Standards

Author collections: CORI KRAMER · Ragini Hari · Keith Shusterman

PharmaSUG · 2017Paper SS02PharmaSUG 2017

Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission

Sandra Minjoe

Source category: Submission Standards

Author collections: Sandra Minjoe

SAS Global Forum · 2017Paper 0855-2017SAS Global Forum 2017

Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission with SAS®

Sandra Minjoe; John Troxell, Accenture Accelerated R&D Services

Source category: Conference presentation

Author collections: Sandra Minjoe

PharmaSUG · 2017Paper DS21PharmaSUG 2017

Programming Efficiency in the Creation of ADaM BDS Datasets

Ellen Lin

Source category: Data Standards

Author collections: Ellen Lin

PharmaSUG · 2017Paper SS12PharmaSUG 2017

Quality Check your CDISC Data Submission Folder Before It Is Too Late!

Bhavin Busa

Source category: Submission Standards

Author collections: Bhavin Busa

PharmaSUG · 2017Paper DS09PharmaSUG 2017

RELREC – SDTM Programmer’s Bermuda Triangle

Charumathy Sreeraman

Source category: Data Standards

Author collections: Charumathy Sreeraman

PharmaSUG · 2017Paper DS03PharmaSUG 2017

SDTM – Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth

Christine Mcnichol

Source category: Data Standards

Author collections: Christine McNichol

PharmaSUG · 2017Paper IB05PharmaSUG 2017

SDTM Cartography – Learn To Create SDTM Mapping Specifications

Donna Sattler; Mike Lozano

Source category: Industry Basics

Author collections: Donna Sattler · Mike Lozano

PHUSE · 2017Paper TT09PHUSE EU Connect 2017

SDTM Domains by Query - is it Possible?

Johannes Ulander

Source category: Trends & Technology

Author collections: Johannes Ulander

PHUSE · 2017Paper DS03PHUSE EU Connect 2017

SDTM vs CDASH: Why You Need Them Both!

Kit Howard; Shannon Labout

Source category: Data Standards & Governance

Author collections: Kit Howard · Shannon Labout

PHUSE · 2017Paper DH11PHUSE EU Connect 2017

SDTM-ADaM Hybrid: Supermodel or Frankenstein?

Ken Stoltzfus

Source category: Data Handling

Author collections: Ken Stoltzfus

PharmaSUG · 2017Paper DS19PharmaSUG 2017

Standardized, Customized or Both? Defining and Implementing (MedDRA) Queries in ADaM Data Sets

Richann Watson; Karl Miller

Source category: Data Standards

Author collections: Richann Watson · Karl Miller

PHUSE · 2017Paper SI09PHUSE EU Connect 2017

Streamline SDTM Development and QC

Stephen Gormley

Source category: Standards Implementation

Author collections: Stephen Gormley

SESUG · 2017Paper LS-105SESUG 2017

Streamlining ADaM Dataset Specifications

Hunter Vega

Source category: Life Sciences Healthcare Insurance

File inside source ZIP: Life_Sciences_Healthcare_Insurance/SESUG2017_Paper-105_Final_PDF.pdf

Author collections: Hunter Vega

PharmaSUG · 2017Paper AD23PharmaSUG 2017

Supporting the CDISC Validation Life-Cycle with Microsoft Excel VBA

Eric Crockett

Source category: Applications Development

Author collections: Eric Crockett

PharmaSUG · 2017Paper DS23PharmaSUG 2017

The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards

Maggie Ci Jiang

Source category: Data Standards

Author collections: Maggie Ci Jiang

PharmaSUG · 2017Paper DS08PharmaSUG 2017

The CDISC SDTM Exposure Domains (EX & EC) Demystified. How EC Helps You Produce A Better (more compliant) EX.

Thomas Guinter

Source category: Data Standards

Author collections: Thomas Guinter

PharmaSUG · 2017Paper DS04PharmaSUG 2017

The CDISC Trial Design Model (TDM), the EPOCH variable, and the Treatment Emergent Flag: How to Leverage these to Improve Review

Thomas Guinter

Source category: Data Standards

Author collections: Thomas Guinter

PharmaSUG · 2017Paper SS10PharmaSUG 2017

The Do’s/Don’ts, An SDTM Validation Perspective. The should/shouldn’t when explaining issues in the Study Data Reviewers Guide

Thomas Guinter

Source category: Submission Standards

Author collections: Thomas Guinter

PharmaSUG · 2017Paper AD03PharmaSUG 2017

Three Issues and Corresponding Work-Around Solution for Generating Define.xml 2.0 Using Pinnacle 21 Enterprise

Jeff Xia; Lugang Larry Xie; Shari Lisnov

Source category: Applications Development

Author collections: Jeff Xia · Lugang Larry Xie