THE COMMUNITY ARCHIVE

SDTM Papers and PresentationsPage 20

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.

441 papers · Showing 381–400

PharmaSUG · 2012Paper DS05PharmaSUG 2012

Seven New SDTM Domains for Medical Devices

Carey Smoak; Fred Wood; Rhonda Facile; Kit Howard

Source category: Data Standards and Quality

Author collections: Carey Smoak · Fred Wood · Rhonda Facile · Kit Howard

PharmaSUG · 2012Paper CC09PharmaSUG 2012

The application of variable-dependent macro on SDTM conversion

Mindy Wang

Source category: Coders’ Corner

Author collections: Mindy Wang

SESUG · 2012Paper PH-01SESUG 2012

The SDTM Programming Toolkit

David Scocca, Rho, Inc.

Source category: Pharma and Healthcare

File inside source ZIP: PH-01.pdf

PharmaSUG · 2012Paper DS01PharmaSUG 2012

Transform Incoming Lab Data into SDTM LB Domain with Confidence

Anthony L. Feliu

Source category: Data Standards and Quality

Author collections: Anthony L. Feliu

SAS Global Forum · 2012Paper 175-2012SAS Global Forum 2012

Using SAS® Macros to Remediate Existing SDTM Data Sets for New Drug Application (NDA) Submission

Han, Yanwei

Source category: Pharma and Health Care Providers

PHUSE · 2011Paper SD09PHUSE EU Connect 2011

"Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission

Niels Mathiesen

Source category: Software Demonstrations

Author collections: Niels Mathiesen

PharmaSUG · 2011Paper CD01PharmaSUG 2011

A Cost-Effective SDTM Conversion for NDA Electronic Submission

Xiangchen (Bob) Cui; Scott Moseley; Min Chen

Source category: CDISC

Author collections: Xiangchen (Bob) Cui · Scott Moseley · Min Chen

PHUSE · 2011Paper CS02PHUSE EU Connect 2011

A SAS macro to check SDTM domains against controlled terminology

Guido Wendland

Source category: Coding Solutions

Author collections: Guido Wendland

PharmaSUG · 2011Paper CD08PharmaSUG 2011

A Special SDTM Domain RELREC and its Application

Changhong Shi; Beilei Xu

Source category: CDISC

Author collections: Changhong Shi · Beilei Xu

PharmaSUG · 2011Paper AD08PharmaSUG 2011

An Excel Framework to Convert Clinical Data to CDISC SDTM Leveraging SAS Technology

Sophie McCallum; Stephen Chan

Source category: Applications Development

Author collections: Stephen Chan

PharmaSUG · 2011Paper SAS-CD01PharmaSUG 2011

Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You’re Sorry When Creating SDTM Domains

Janet Stuelpner; Jack Shostak

Source category: SAS Presents

Author collections: Janet Stuelpner · Jack Shostak

SAS Global Forum · 2011Paper 205-2011SAS Global Forum 2011

Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You®re Sorry When Creating SDTM Domains

Janet Stuelpner; Jack Shostak

Source category: Pharma

Author collections: Janet Stuelpner · Jack Shostak

PharmaSUG · 2011Paper AD14PharmaSUG 2011

Creating a define.xml file for ADaM and SDTM

John H. Adams

Source category: Applications Development

Author collections: John H. Adams

PHUSE · 2011Paper CD10PHUSE EU Connect 2011

Creating ADaM Friendly Analysis Data from SDTM Using Meta Data

Erik Brun; Rico Schiller

Source category: CDISC & Industry Standards

Author collections: Erik Brun

PharmaSUG · 2011Paper HW03PharmaSUG 2011

Creating SDTM Datasets from Legacy Data

Fred Wood

Source category: Hands-On Workshops

Author collections: Fred Wood

PharmaSUG · 2011Paper CD10PharmaSUG 2011

Efficiencies Realized in Building and Utilizing ADaM from SDTM

Shirish Nalavade; Parag Shiralkar

Source category: CDISC

Author collections: Shirish Nalavade · Parag Shiralkar

PHUSE · 2011Paper CD04PHUSE EU Connect 2011

Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies - an ICON Approach

Jennie McGuirk; Steven Thacker

Source category: CDISC & Industry Standards

Author collections: Jennie McGuirk

PharmaSUG · 2011Paper CD21PharmaSUG 2011

Ensuring Consistent Data Mapping Across SDTM-based Studies – a Data Warehouse Approach

Annie Guo

Source category: CDISC

Author collections: Annie Guo

PHUSE · 2011Paper PP15PHUSE EU Connect 2011

Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD

Carl Herremans; Qian Wang

Source category: Poster Presentations

Author collections: Carl Herremans · Qian Wang

PHUSE · 2011Paper RG03PHUSE EU Connect 2011

FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards

Peter Van Reusel; Tina Apers

Source category: Regulatory

Author collections: Peter Van Reusel · Tina Apers