A Practical Exploration of SEND for CBER Submissions
Source category: Data Standards & Governance
Author collections: Jack Baker
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 14
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 261–280
A SAS Macro to Aid Assembly Review of M5 Module in Submission
Source category: Applications Development
Author collections: Jeff Xia
A SAS Macro to Support the Supplemental Qualifier Section in cSDRG
Source category: Submission Standards
A Standardized Reviewer’s Guide for Clinical Integrated Analysis Data
Source category: Submission Standards
Author collections: Srinivas Kovvuri · Kiran Kundarapu · Satheesh Avvaru · Randi McFarland
Automating Analysis Result Metadata
Source category: Submissions & Agencies
Author collections: Ghanshyam Jangid
Automation of the CDISC Pilot Study – From File-new to Submission Package in 20 Minutes
Source category: Application Development
Author collections: Stuart Malcolm
Bioresearch Monitoring Data Reviewer’s Guide (BDRG)
Source category: Submissions & Agencies
Damn*t, The Define!
Source category: Submission Standards
Author collections: Julie Ann Hood · Sarah Angelo
Digital Biomarkers in Clinical Submissions
Source category: Poster Presentations
Author collections: Unnat Patel · Vijay Pasapula
eCOA and SDTM: Bring Order to the Wild West
Source category: Submission Standards
Author collections: Vincent Allibone · Frank Menius · Monali Khanna
Explanations in the Study Data Reviewer’s Guide: How’s It Going?
Source category: Submission Standards
Author collections: Kristin Kelly
Explanations in the Study Data Reviewer’s Guide: How’s It Going?
Source category: Data Standards & Governance
Author collections: Kristin Kelly
FDA Advisory Committee Meetings– A Statistical Programmer’s Survival Guide
Source category: Submission Standards
Author collections: Phil Hall
FDA Study Data Technical Rejection Criteria (TRC): What You Need to Know!
Source category: Submissions & Agencies
Generating Bar Chat and Mutipanel graphs using SAS vs R for Regulatory Submission
Source category: Data Visualization and Reporting
Author collections: Girija Javvaji
Generating Forest and Kaplan Meier graphs for Regulatory Submission: Comparison of SAS and R
Source category: Data Visualization and Reporting
Author collections: Girija Javvaji · Sivasankar Konda
Generating Statistical Figures for Regulatory Submission: Comparison of SAS and R
Source category: Data Visualization
Author collections: Girija Javvaji · Sivasankar Konda
Going through an AdCom with the FDA: The Ultimate Programming Experience
Source category: Submissions & Agencies
Author collections: Frederikke Høyer
Harnessing AIML Technologies to Expedite Anonymisation of Unstructured Data: Implications for the EU CTR
Source category: Submissions & Agencies
Author collections: Muhammad Oneeb Rehman Mian
Health Authorities Inspections: What to Expect? A Statistical Programmer Experience
Source category: Submissions & Agencies