Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission
Source category: Pharma and Health Care Providers
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 33
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 641–660
Automatic Detection and Identification of Variables with All Missing Values in SDTM/ADaM Datasets for FDA Submission
Source category: Coders’ Corner
Author collections: Min Chen · Xiangchen (Bob) Cui
Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA Submission
Source category: Coders’ Corner
Author collections: Xiangchen (Bob) Cui · Min Chen
Considerations in the Submission of Exposure Data in an SDTM-Compliant Format
Source category: Data Standards and Quality
Author collections: Fred Wood · Jerry Salyers · Richard Lewis
Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTM-Compliant Format
Source category: Data Standards and Quality
Author collections: Fred Wood · Peter Schaefer · Richard Lewis
Error Reduction and Report Automation Approaches for Textually Dense Pharmaceutical Regulatory Conformance Incident Data
Source category: Pharma and Health Care Providers
Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission
Source category: Posters
Spotting DILI for FDA Submission
Source category: Regulations in the Healthcare Industry
Author collections: Nicola Tambascia · Sven Greiner
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
Using SAS® Macros to Remediate Existing SDTM Data Sets for New Drug Application (NDA) Submission
Source category: Pharma and Health Care Providers
"Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission
Source category: Software Demonstrations
Author collections: Niels Mathiesen
A Cost-Effective SDTM Conversion for NDA Electronic Submission
Source category: CDISC
Author collections: Xiangchen (Bob) Cui · Scott Moseley · Min Chen
A Non-Invasive Macro to Track Submission Metadata in SAS Drug Development
Source category: Coders Corner
Author collections: Katrina E. Canonizado · Bradford J. Danner · Matthew J. Wiedel
A Non-Invasive Macro to Track Submission Metadata in SAS® Drug Development
Source category: Posters
Author collections: Katrina E. Canonizado · Bradford J. Danner · Matthew J. Wiedel
Automating the Process of Preparing Data Definition Document for NDA Electronic Submission from Programming Specification in Word Format
Source category: CDISC
Author collections: Min Chen · Xiangchen (Bob) Cui · Scott Moseley
FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards
Source category: Regulatory
Author collections: Peter Van Reusel · Tina Apers
Modular Programming - Some Lessons Learned and Benefits Gained
Source category: Regulatory
Author collections: Ross Farrugia
Preparing an eSubmission based on multiple trials, some of which are ongoing- challenges for statistical programmers
Source category: Regulatory
Remapping of Codes (and of course Decodes) in Analysis Data Sets for Electronic Submissions
Source category: Data Handling
Author collections: Joerg Guettner
Understanding NDA/BLA Clinical Data Submission
Source category: Regulatory
Publisher slides file PRE_RG04.pdf returned HTTP 403 on 17 October 2026.
Author collections: Dirk Spruck