MDMAP: An application utilized in the mgmt of trial metadata
Source category: CDISC and Regulatory
Author collections: Eric Sorel
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 36
Browse practical work on assembling, validating and documenting clinical data for regulatory review. Conference examples reflect their publication date; consult current agency guidance when deciding how an approach applies to a new submission.
747 papers · Showing 701–720
Navigating a Major Regulatory Submission Project to Success
Source category: Conference paper
Author collections: Alan Meier
Presentation of the demo of standardization of the ADS/SDS
Source category: CDISC and Regulatory
Author collections: Claude Guyot
Relationships between CDISC variables concerning day and date
Source category: CDISC and Regulatory
Author collections: Susan Fehrer · Russ Lavery
Relationships between CDISC variables linking domains (relrec)
Source category: CDISC and Regulatory
Author collections: Susan Fehrer · Russ Lavery
Seven Steps to Regulatory Publication Style with PROC REPORT
Source category: Conference paper
Author collections: Dennis Gianneschi
Standardization of submission data sets and analysis data sets
Source category: CDISC and Regulatory
Author collections: Yvane Boudraa
Standardizing FDA data to improve success in pediatric drug development
Source category: CDISC and Regulatory
Author collections: Julie Maddox · Chris Decker
Converting Data to the SDTM Standard Using SAS Data Integration Studio
Source category: Regulatory Affairs
Publisher paper file PAP_RAO1.pdf returned HTTP 403 on 17 October 2026.
SAS macro validation criteria
Source category: Regulatory Affairs
Author collections: Jim Groeneveld
The Submission Data File System Automating the Creation of CDISC SDTM and ADaM Datasets
Source category: Applications and Software Development
Author collections: David Edwards
The use of CDISC Standards in SAS from Data Capture to Reporting
Source category: Regulatory Affairs
Author collections: Andrew Fagan · John Leveille
Using CDISC Models for the Analysis of Safety Data
Source category: Regulatory Affairs
Author collections: SUSAN KENNY · Ed Helton
A Regulatory Compliant Process for Developing SAS -Based Reports
Source category: SAS Solutions
Author collections: Chuck Reap
A Regulatory Compliant Process for Developing SAS-Based Reports
Source category: Conference paper
Author collections: Chuck Reap
Implementing CFR 21 part 11 for SAS without tears or joins
Source category: Regulatory Compliance, Electronic Submission & Validation
Author collections: Dave Garbutt
Pharmacovigilance Using SAS Technology , Analytics and CDISC Data Standards, including the SDTM-ADaM Submission Relationship
Source category: CDISC and XML
Author collections: Ed Helton
QualityView - a SAS program database and validation documentation tool
Source category: Regulatory Compliance, Electronic Submission & Validation
Author collections: Peter Gerber
Regulatory Compliant Validation and Deployment of SAS Programs with the Colibri Server
Source category: Regulatory Compliance, Electronic Submission & Validation
Author collections: Andreas Mangold
The European System for Monitoring Drug Safety, EudraVigilance
Source category: Regulatory Compliance, Electronic Submission & Validation