The Role of Data Analytics Functions in Studies Utilising RWD for Submissions
Source category: Real-world Evidence
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 16
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 301–320
Trial Summary SDTM Domain Made Easy for Regulatory Submissions
Source category: Standards Implementation
Author collections: Kishore Pothuri
Using Janssen’s ADaM Submission RPA Bot to Successfully Prepare for Delivery of an ADaM Submission Package
Source category: Poster Presentations
Using SAS® to Prepare Postsecondary Data Partnership (PDP) Data Submission Files
Source category: Industry Applications
Author collections: Bobbie Frye
Vision and Demonstration of the OpenStudyBuilder for Supporting Structured Protocol Content and Submission Deliverables Using Concept-based Standards
Source category: Poster Presentations
Author collections: Martin Gram · Mikkel Traun
A Diagnostic Report for SAS Submission Programs
Source category: Applications Development
Author collections: Yang Gao · Christine Teng
A Lead Programmer’s Guide to a Successful Submission
Source category: Submission Standards
A Process to Validate Internal Developed R Package under Regulatory Environment
Source category: Strategic Implementation
Author collections: Madhusudhan Ginnaram · Amin Shirazi · Simiao Ye · Yalin Zhu · Yilong Zhang
Assembling Reviewer-friendly eSubmission Packages
Source category: Submission Standards
Author collections: Shefalica Chand
BIMO SAS Macros and Programming Tools
Source category: Submission Standards
Author collections: Mi Young Kwon
Challenges and Solutions for an ISM Development
Source category: Submission Standards
Author collections: Yanhong Li
China Center for Drug Evaluation, NMPA Electronic Study Data Submission Requirements
Source category: Submissions & Agencies
Author collections: Majdoub Haloui · Yanhong Li
Commercially Confidential Information in clinical data publishing
Source category: Submissions & Agencies
Author collections: Parveen Kumar
Common JumpStart Data Quality Findings
Source category: Submissions & Agencies
Author collections: Alan Shapiro
Concept of Generating Polished SAS Code for Regulatory Submissions
Source category: Poster Presentation
Author collections: Norihiko Oharu · Ravi Mokkarala
COVID-19 Presentation: CO02: Takeda’s COVID-19 Response to Aid Collection to Submission
Source category: Drug Development
Author collections: Veena Nataraj
Data Visualizations for Publication, Decision-making and Submission
Source category: Data Visualisations
Author collections: Maria Dalton
Design ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML in CDISC Era
Source category: Submission Standards
Author collections: Xiang Wang
Do's and Don’ts for PRCI Submissions
Source category: Poster Presentation
Author collections: Parveen Kumar
e-Submissions key difference of FDA and PMDA
Source category: ePosters