HL7, CDISC, and the FDA�Moving on Down the Path to Data Standards
Source category: Pharma, Life Sciences and Healthcare
Author collections: Steve Wilson
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 54
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.
1,130 papers · Showing 1061–1080
How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard
Source category: CDISC Methodologies for FDA Submissions
Author collections: Ted J. Guo
Implementation of ADaM standards NOT driven by a submission
Source category: CDISC and Industry Standards
Implementation of CDISC Standards at Nycomed
Source category: Regulatory
Implementing CDISC When You Already Have Standards: A Case Study
Source category: Pharma, Life Sciences and Healthcare
Author collections: Sandra Minjoe
Insights into ADaM
Source category: CDISC and Industry Standards
Kendle Implementation of CDASH
Source category: CDISC and Industry Standards
Mapping CDISC Metadata Attributes: Using DATA _NULL_ and PROC DATASETS in SAS®
Source category: Posters
Author collections: Rita Tsang
SDTM Validation: How can we do it right?
Source category: CDISC and Industry Standards
Author collections: Peter Van Reusel
Standardization of data base: interaction between Biostatistics and Clinical Data Management
Source category: CDISC and Industry Standards
Author collections: Celine Tendero
Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
Source category: Pharma, Life Sciences and Healthcare
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
Source category: CDISC Methodologies for FDA Submissions
The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review
Source category: CDISC and Industry Standards
Author collections: Chris Decker
The SAS Clinical Standards Toolkit
Source category: CDISC and Industry Standards
Author collections: David Smith
The Second CDISC Pilot Project: A Metastandard for Integrating Databases
Source category: CDISC Methodologies for FDA Submissions
Author collections: Gregory C. Steffens · Ian Fleming
The Second CDISC Pilot Project: Standards for Integrating Databases
Source category: Pharma, Life Sciences and Healthcare
Author collections: Ian Fleming · Gregory Steffens
Using SAS Clinical Data Integration Server to Implement and Manage CDISC Standards
Source category: CDISC and Industry Standards
Author collections: Julie Maddox
Using SAS Macros to simplify preparation and validation of SDTM data, Annotated CRFs and Define.xml in a metadata driven environment
Source category: CDISC and Industry Standards
Author collections: Niels Both
Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
Source category: Pharma, Life Sciences and Healthcare
Author collections: Michael Kilhullen
CDISC Implementation Strategies: Exploit your data assets while still giving the FDA what they want
Source category: CDISC
Author collections: David Smith