PP19 Take Advantage of CDISC Standards and Plan Your Study Specifications File
Source category: Poster Presentations
Author collections: Vara Sakampally
THE COMMUNITY ARCHIVE
PHUSE 2019 Papers ArchivePage 6
Browse indexed publications from PHUSE in 2019. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.
323 papers · Showing 201–240
PP20 Holon – What, Why and How
Source category: Poster
Author collections: Catharina Dahlbo
PP20 Metadata Framework for Script Repository and Development
Source category: Poster Presentations
Author collections: Vara Sakampally · Hanming Tu
PP21 ADaM Programming Made Easy – Common ADaM Templates and an SAS Macro Library
Source category: Poster
Author collections: Niels-Kristian Kjøller
PP22 Overlays Data Capture Architecture (ODCA): Providing a Standardised Global Solution for Data Capture
Source category: Poster
PP23 Modern Analytics within an Open-source SCE – Are We Still Dreaming?
Source category: Poster
Author collections: Sam Warden · Ali Dootson
PP24 Data Anonymisation & Risk Assessment – Process Map and Automation Efforts
Source category: Poster
Author collections: Lukasz Kniola
PP25 An Algorithm for Prioritising Time- constrained Clinical Trial Activities
Source category: Poster
Author collections: Andy Richardson
PP27 Vaccines Impact: Benefits for Human Health
Source category: Poster
Author collections: Mickael Borne
RW01 Utilising RWD and RWE: An Introduction to Core Concepts and Requirements
Source category: Real World Evidence
Author collections: Christopher Hurley · Aditya Gadiko
RW02 The Promise of Wearable Technology in Clinical Trials: A Proof of Concept to Deliver it?
Source category: Real World Evidence
RW03 Early Experiences Using SDTM to Organise Clinical Data Collected Using a Physical Activity Tracker
Source category: Real World Evidence
Author collections: Martin Gram · Gianluca Mortari
RW04 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis
Source category: Real World Evidence
Author collections: Jeff Abolafia
RW05 Using Natural Language Processing to Transform Real-world Data
Source category: Real World Evidence
Author collections: Jane Reed
RW06 Deriving Line of Therapy: An Algorithmic Approach in a Real-world Oncology Database
Source category: Real World Evidence
RW07 Analysing Real-world Data – Case Study
Source category: Real World Evidence
Author collections: Anik Chatterjee
SA01 Development of the Standard BIMO Process to Create the Clinsite Dataset
Source category: Submissions and Agencies
SA01 The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing: Synergies and Differences
Source category: Submissions & Agencies
Author collections: Jean-Marc Ferran
SA02 Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective
Source category: Submissions and Agencies
SA02 Machine-readable Data Not Required for the EMA...Really?
Source category: Submissions & Agencies
Author collections: David Izard
SA03 ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements
Source category: Submissions and Agencies
Author collections: Marianne Carames
SA03 High-quality Study Data Standards for Submission
Source category: Submissions & Agencies
Author collections: Majdoub Haloui · Ellen Asam
SA04 Processing Big Data from Multiple Sources
Source category: Submissions and Agencies
Author collections: Berber Snoeijer · Vijay Pasapula
SA04 Submission of Software Programs to Regulatory Agencies
Source category: Submissions & Agencies
Author collections: Maria Dalton
SA05 Approach of Programming Production Harmonized with Submission
Source category: Submissions & Agencies
Author collections: Chengxin Li
SA05 How Metadata Can Help Drive the Creation of Tables, Figures and Listings
Source category: Submissions and Agencies
Author collections: Judith Goud · Stephen Castellano
SA06 Developing SEND for CBER – Collaborative Workstream Initiative
Source category: Submissions & Agencies
Author collections: Lisa Lin · Susan DeHaven
SA06 Integrated Data and Document Anonymisation for Efficient Data Sharing
Source category: Submissions and Agencies
Author collections: Ali Dootson · Cathal Gallagher
SA07 Navigating FDA Requirements: ISS/ISE Build Strategies
Source category: Submissions and Agencies
Author collections: Priyank Patel
SA07 The Benefits, Challenges and Myths of SEND
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer
SA08 Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND)
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer
SA09 Impact of SEND Data on FDA Review of Nonclinical Studies
Source category: Submissions & Agencies
Author collections: Kevin Snyder
SA10 Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service
Source category: Submissions & Agencies
Author collections: Jesse Anderson · Christopher Bartlett
SA13 The Clinical Data Specialist Role Within Regulatory Review
Source category: Submissions & Agencies
Author collections: Joy Li
SA15 FDA View: Update on Study Data Submission
Source category: Submissions & Agencies
Author collections: Ethan Chen · Lilliam Rosario
SA17 Streamlining the Results Reporting for ClinicalTrials.gov and EudraCT
Source category: Submissions & Agencies
Author collections: Susruth Ganoothula
SAS Outputs in Excel Workbook Using ODS Excel
Source category: Coding Tips and Tricks
SAS/STAT High-performance Statistics Procedures Contrasted with their Legacy Counterparts
Source category: Analytics and Statistics
SD01 DR3 – A Tool to Create Define-XML (SDTM/ADaM with ARM)
Source category: Software Demonstrations
Author collections: Eric Weising
SD01 Formedix On: Advanced Metadata Management and Data Conversion
Source category: Software Development
Author collections: Kevin Burges