A Macro Tool to Find and/or Split Variable Text String Greater Than 200 Characters for Regulatory Submission Datasets
Source category: Coding Tips & Tricks
Author collections: Venkata Madhira
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 25
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 481–500
A Macro Tool to Find and/or Split Variable Text String Greater Than 200 Characters for Regulatory Submission Datasets
Source category: Industry Solutions
Author collections: Venkata Madhira · Harish Yeluguri
Accessing the Metadata from Define-XML
Source category: Submission Standards
Author collections: Lex Jansen
Achieving Highest Quality and Usability of SEND through Industry and Regulatory Collaboration
Source category: Regulatory
Author collections: William Houser · Lou Ann Kramer
An eSubmission Tracking Tool for both Components and Timelines
Source category: Strategic Implementation
Author collections: Todd Case
Assuring Data Integrity and Data Quality in Sponsor Submissions
Source category: Regulatory
Automated Creation of Submission-ready Artifacts
Source category: Data Handling
Author collections: Silas Mckee · Lourdes Devenney
Automated Creation of Submission-Ready Artifacts
Source category: Data Handling
Author collections: Lourdes Devenney · Silas Mckee
Best Practice for Explaining Validation Results in the Study Data Reviewer’s Guide
Source category: Submission Standards
Author collections: Kristin Kelly
Best Practice for Explaining Validation Results in the Study Data Reviewer’s Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
Best Practices for Explaining Validation Results in the Study Data Reviewer's Guide
Source category: Data Standards and Governance
Author collections: Kristin Kelly
BIMO Listings - Check That Off Your NDA To-Do List
Source category: Regulatory
Author collections: Charanjit Kahlon · Bhavin Busa
Biomedical Informatics in the Office of New Drugs CDER/FDA
Source category: Regulatory
Author collections: Vaishali Popat
Breaking Away from Shell Scripts for Batch Mode Submissions on SAS GRID
Source category: Trends & Technologies
CDER’s Clinical Investigator Site Selection Tool
Source category: Regulatory
Challenges for Implementing Study Data Standardization Plan (SDSP) in Legacy Data Submission
Source category: Submission Standards
Challenges of Submitting Electronic Study Data to Two Authorities: The PMDA & FDA
Source category: Submissions & Agencies
Coming soon: ADNCA and the PK submission
Source category: Data Standards
Author collections: Luke Reinbolt
Common Data Related Review Issues and Prevention: A Statistical Reviewer’s Thoughts
Source category: Regulatory (FDA/PMDA)
Compare Pharmacokinetic Data Submission Processes in CDISC Environment
Source category: Application Development
Author collections: Xiaopeng Li · Shallabh Mehta