Use of Real-Time Application for Portable Interactive Device (RAPID) for Data safety and Patient Out
Source category: Regulatory
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 28
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 541–560
Using SAS® Visual Investigator to Enforce Model Tuning Best Practices in a Regulatory Environment
Source category: Conference presentation
Want Submission-Ready Datasets Package from the Get-Go?
Source category: Submission Standards
Author collections: Kishore Pothuri · Bhavin Busa
Want Submission-Ready Datasets Package from the Get-Go?
Source category: Standards Implementation
Watch Out For Blind Spots While Keeping Up With the Speed of Evolving Standards and Regulations
Source category: Submission Standards
Author collections: Srinivas Veeragoni
What Medical Reviewers Can Do With Standardized Data and Metadata Received in Module 5
Source category: Regulatory (FDA/PMDA)
Author collections: Eileen Navarro
Why organizations need MDR systems to manage metadata?
Source category: Submission Standards
Author collections: Abhinav Jain
A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices
Source category: Data Standards
Author collections: Carey Smoak
A Precision-strike Approach to Submission Readiness: How to Prepare Your Filing Teams for Consistent Excellence
Source category: Posters
Author collections: Michael Hagendoorn · Tony Chang
An FDA Submission Experience Using the CDISC Standards
Source category: Regulatory
Author collections: Angelo Tinazzi · Cedric Marchand
Assessing New CFDARequirements on Data Integrity Using Risk-Based Monitoring and Enrolment Pattern
Source category: Regulatory
Awareness from Electronic Data Submission to PMDA and FDA — Lesson & Learnt from hands-on experiences —
Source category: Submission Standards
Author collections: Yuichi Nakajima · Takashi Kitahara · Ryan Hara
Considerations and Conventions in the Submission of the SDTM Tumor and Response Domain
Source category: Data Standards & Governance
Author collections: Jerry Salyers · Fred Wood
Considerations and Conventions in the Submission of the SDTMIG Tumor and Response Domains
Source category: Data Standards
Author collections: Jerry Salyers · Fred Wood
Converting Legacy Data to "ADaM-like" Data for Making Efficient Regulatory Response
Source category: Data Handling
The publisher-listed Slides file is currently unavailable.
Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
Source category: Submission Standards
Author collections: Lex Jansen
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide
Source category: Submission Standards
Author collections: David Izard · Kristin Kelly
End-to-End Traceability from Protocol Development to Submission
Source category: Standards Implementation
Author collections: Mikkel Traun · Trine Danø Klingberg
Evaluation of Re-identification Risk for Anonymized Clinical Documents
Source category: Regulatory
Extension Studies - CDISC Submission Challengesand Scenarios
Source category: Regulatory