Developing Integrated Summary of Safety Database using CDISC Standards
Source category: Health Outcomes and Healthcare Research Methodologies
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 48
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 941–960
Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission
Source category: Posters
Experiences in Leading a Company-Wide First CDISC Filing from a Programming Perspective
Source category: Data Standards and Quality
Generating SUPPQUAL Domains from SDTM-Plus Domains
Source category: Pharma and Healthcare
File inside source ZIP: PH-11.pdf
Generating SUPPQUAL Domains From SDTM-Plus Domains
Source category: Data Standards and Quality
Author collections: John R Gerlach
Interpreting ADaM Standards with OpenCDISC
Source category: CDISC & Industry Standards
Let SAS Handle your CDISC Compliance Check: Automating OpenCDISC Validator in SAS
Source category: Technical Solutions
Author collections: Edwin van Stein
Mapping the Company's Legacy Data Model to SDTM
Source category: CDISC & Industry Standards
Author collections: Anja Feuerbacher
Multiple Applications of ADaM Time-to-Event Datasets
Source category: Data Standards and Quality
Author collections: Huei-Ling Chen · Helen Wang
OpenCDISC Plus
Source category: Applications Development
Author collections: Annie Guo
POSTER: ADaM Implications of the CDER Data Standards Common Issues Document
Source category: Conference paper
Author collections: Sandra Minjoe
Real-World Application of the Protocol Representations Model
Source category: CDISC & Industry Standards
SAS® Clinical Standards Toolkit: define.xml and Value Level Metadata
Source category: CDISC & Industry Standards
Author collections: Gene Lightfoot
SAS® Macros to Transpose SDTM Data Sets Automatically
Source category: Pharma and Health Care Providers
SDTM and AdaM: Metadata Playing Together Nicely
Source category: CDISC & Industry Standards
Author collections: Kenneth Stoltzfus
SDTM Domain Development on the Critical Path – Strategies for Success
Source category: Management and Support
Author collections: David C. Izard
SDTM Domain Mapping with Structured Programming Methodology
Source category: Data Standards and Quality
Author collections: Chengxin Li · Nancy Bauer
SDTM, ADaM and define.xml with OpenCDISC®
Source category: Hands-On Workshops
Author collections: Matt Becker
Seven New SDTM Domains for Medical Devices
Source category: Data Standards and Quality
Author collections: Carey Smoak · Fred Wood · Rhonda Facile · Kit Howard
Streamlining Regulatory Submission with CDISC/ADaM Standards for Non-standard Pharmacokinetic/Pharmacodynamic Analysis Datasets
Source category: Posters
Author collections: Xiaopeng Li · Chun Feng · Nancy Wang