Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies
Source category: Submission Standards
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 9
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.
622 papers · Showing 161–180
Ensuring Governance and Traceability of RWD from Source to Regulatory Submission: Use Case
Source category: Real-world Evidence
Author collections: Berber Snoeijer
Evaluating the ‘Fit for Purpose’ of Real-World Data Sources for Regulatory Submissions
Source category: Poster Presentations
Author collections: Berber Snoeijer · Lakshmi Mantha
Experimenting with Containers and webR for Submissions to FDA in the Pilot 4
Source category: Submission Standards
Author collections: André Veríssimo
Exploring the Potential Use of Generative AI in the Regulatory Review Process
Source category: Submissions & Agencies
Author collections: Qingying Ally Lu
From Source to Submission: Getting the Best of Multiple Standards
Source category: Data Standards & Governance
Author collections: Jules van der Zalm · Berber Snoeijer
Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model
Source category: Real-world Evidence
Author collections: Jeffrey Abolafia
Harmonising FDA and PMDA Submission Requirements
Source category: Submissions & Agencies
HoW - Your First Submission in R
Source category: Programming Languages
Author collections: Kristian Trøjelsgaard · Steffen Falgreen Larsen
How to generate a submission ready ADaM for complex data
Source category: Submission Standards
Author collections: Tina Wu
Implementing CDISC CORE in a Cloud-Native, Regulated Environment to Support Rare Diseases Submissions
Source category: Standards Implementation
Author collections: Stijn Rogiers · Emmy Pahmer
Interactive Session – The State of Open Source Technology in Clinical Data Analysis, Reporting, and Submissions – A PHUSE Manuscript
Source category: Technology & Applications
Author collections: Katja Glass · Michael Rimler
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA?
Source category: Submission Standards
Author collections: Sandra Minjoe
Lead-in and extension trials, how we documented datapoint traceability
Source category: Submission Standards
Leveraging ‘Ensemble’ Machine Learning Models to Drive Automation of Specification Generation and Data Mapping in Clinical Trial Data Submission
Source category: Machine Learning, AI and Large Language Models
Author collections: Venu Mallarapu
Leveraging SAS and Adobe Plug-in for CRF Bookmark Generation (Rave studies)
Source category: Submission Standards
Making SDTM/ADaM CRT Packages Submission Ready
Source category: Submissions & Agencies
Author collections: Phillip Spowart
Navigating First Data Submission: Pierre Fabre’s Journey and Insights into Data Submission Challenges with the NMPA
Source category: Submissions & Agencies
Navigating Success: Exploring AI-Assisted Approaches in Predicting and Evaluating Outcome of Clinical Trials and Submissions
Source category: Strategic Implementation & Innovation
Author collections: Ruohan Wang · Chris Qin
Navigating the Clinical Research Landscape: The Role of Regulatory Intelligence and LLMs
Source category: Standards Implementation
Author collections: Federica Citterio · Soundarya Palanisamy