THE COMMUNITY ARCHIVE

PHUSE Papers ArchivePage 72

Browse indexed publications from PHUSE. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.

3,716 papers · Showing 2841–2880

PHUSE · 2019Paper PP12PHUSE EU Connect 2019

PP12 Speed Breaker, Traffic Signal and Toll Gates of a Highway Journey of a Sponsor–Vendor Relationship

Anik Chatterjee; Anusuiya Ghanghas

Source category: Poster

Author collections: Anik Chatterjee · Anusuiya Ghanghas

PHUSE · 2019Paper PP13PHUSE EU Connect 2019

PP13 Seven Habits of Highly Effective (Validation Issue) Managers

Amy Garrett

Source category: Poster

Author collections: Amy Garrett

PHUSE · 2019Paper PP13PHUSE US Connect 2019

PP13 Tame Your SHARE with a Python and SAS

Terek Peterson; Michael Stackhouse

Source category: Poster Presentations

Author collections: Terek Peterson · Michael Stackhouse

PHUSE · 2019Paper PP14PHUSE US Connect 2019

PP14 Best Practices for the Preparation of the ISS/ISE Datasets

Aatiya Zaidi; Bhavin Busa

Source category: Poster Presentations

Author collections: Bhavin Busa

PHUSE · 2019Paper PP14PHUSE EU Connect 2019

PP14 Dynamic Footnotes – Be More Dynamic Than Your Statistician

Wilfried Esken

Source category: Poster

PHUSE · 2019Paper PP15PHUSE EU Connect 2019

PP15 Automating the blankcrf.pdf and Define-XML from Your Database Build

John Mcdade

Source category: Poster

Author collections: John McDade

PHUSE · 2019Paper PP15PHUSE US Connect 2019

PP15 SDSP (Study Data Standardization Plan) Case Studies and Considerations

Kiran Kundarapu; Nicole Gallegos

Source category: Poster Presentations

Author collections: Kiran Kundarapu

PHUSE · 2019Paper PP16PHUSE US Connect 2019

PP16 Have You Ever Wanted to Join a CDISC Team?

Amy Palmer

Source category: Poster Presentations

PHUSE · 2019Paper PP16PHUSE EU Connect 2019

PP16 Linked Data URIs

Kerstin Forsberg; Johannes Ulander

Source category: Poster

Author collections: Kerstin Forsberg · Johannes Ulander

PHUSE · 2019Paper PP18PHUSE EU Connect 2019

PP18 PHUSE CDISC Implementation Primer Project Overview and Update

Beate Hientzsch; Nick De Donder

Source category: Poster

Author collections: Beate Hientzsch · Nick De Donder

PHUSE · 2019Paper PP18PHUSE US Connect 2019

PP18 The Importance of Work Instructions When Creating Reviewer's Guides

Jennifer McGrogran

Source category: Poster Presentations

PHUSE · 2019Paper PP19PHUSE EU Connect 2019

PP19 Janssen Autism Knowledge Engine (JAKE) System in Autism Spectrum Disorder

Sarah Bonneux

Source category: Poster

PHUSE · 2019Paper PP19PHUSE US Connect 2019

PP19 Take Advantage of CDISC Standards and Plan Your Study Specifications File

Vara Sakampally; Siddarth Lokineni

Source category: Poster Presentations

Author collections: Vara Sakampally

PHUSE · 2019Paper PP20PHUSE EU Connect 2019

PP20 Holon – What, Why and How

Catharina Dahlbo

Source category: Poster

Author collections: Catharina Dahlbo

PHUSE · 2019Paper PP20PHUSE US Connect 2019

PP20 Metadata Framework for Script Repository and Development

Vara Sakampally; Hanming Tu

Source category: Poster Presentations

Author collections: Vara Sakampally · Hanming Tu

PHUSE · 2019Paper PP21PHUSE EU Connect 2019

PP21 ADaM Programming Made Easy – Common ADaM Templates and an SAS Macro Library

Niels-Kristian Kjøller

Source category: Poster

Author collections: Niels-Kristian Kjøller

PHUSE · 2019Paper PP22PHUSE EU Connect 2019

PP22 Overlays Data Capture Architecture (ODCA): Providing a Standardised Global Solution for Data Capture

Paul Knowles

Source category: Poster

PHUSE · 2019Paper PP23PHUSE EU Connect 2019

PP23 Modern Analytics within an Open-source SCE – Are We Still Dreaming?

Sam Warden; Ali Dootson

Source category: Poster

Author collections: Sam Warden · Ali Dootson

PHUSE · 2019Paper PP24PHUSE EU Connect 2019

PP24 Data Anonymisation & Risk Assessment – Process Map and Automation Efforts

Lukasz Kniola

Source category: Poster

Author collections: Lukasz Kniola

PHUSE · 2019Paper PP25PHUSE EU Connect 2019

PP25 An Algorithm for Prioritising Time- constrained Clinical Trial Activities

Andy Richardson

Source category: Poster

Author collections: Andy Richardson

PHUSE · 2019Paper PP27PHUSE EU Connect 2019

PP27 Vaccines Impact: Benefits for Human Health

Mickael Borne

Source category: Poster

Author collections: Mickael Borne

PHUSE · 2019Paper RW01PHUSE EU Connect 2019

RW01 Utilising RWD and RWE: An Introduction to Core Concepts and Requirements

Christopher Hurley; Aditya Gadiko

Source category: Real World Evidence

Author collections: Christopher Hurley · Aditya Gadiko

PHUSE · 2019Paper RW02PHUSE EU Connect 2019

RW02 The Promise of Wearable Technology in Clinical Trials: A Proof of Concept to Deliver it?

Jennifer Bradford

Source category: Real World Evidence

PHUSE · 2019Paper RW03PHUSE EU Connect 2019

RW03 Early Experiences Using SDTM to Organise Clinical Data Collected Using a Physical Activity Tracker

Martin Gram; Gianluca Mortari

Source category: Real World Evidence

Author collections: Martin Gram · Gianluca Mortari

PHUSE · 2019Paper RW04PHUSE EU Connect 2019

RW04 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis

Jeff Abolafia

Source category: Real World Evidence

Author collections: Jeff Abolafia

PHUSE · 2019Paper RW05PHUSE EU Connect 2019

RW05 Using Natural Language Processing to Transform Real-world Data

Jane Reed; Thierry Breyette

Source category: Real World Evidence

Author collections: Jane Reed

PHUSE · 2019Paper RW06PHUSE EU Connect 2019

RW06 Deriving Line of Therapy: An Algorithmic Approach in a Real-world Oncology Database

Matthew Thompson

Source category: Real World Evidence

PHUSE · 2019Paper RW07PHUSE EU Connect 2019

RW07 Analysing Real-world Data – Case Study

Anik Chatterjee; Sibasish Saha

Source category: Real World Evidence

Author collections: Anik Chatterjee

PHUSE · 2019Paper SA01PHUSE EU Connect 2019

SA01 Development of the Standard BIMO Process to Create the Clinsite Dataset

Hilde Delanghe

Source category: Submissions and Agencies

PHUSE · 2019Paper SA01PHUSE US Connect 2019

SA01 The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing: Synergies and Differences

Jean-Marc Ferran

Source category: Submissions & Agencies

Author collections: Jean-Marc Ferran

PHUSE · 2019Paper SA02PHUSE EU Connect 2019

SA02 Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective

Delphine Kerzerho; Hiren Naygandhi

Source category: Submissions and Agencies

PHUSE · 2019Paper SA02PHUSE US Connect 2019

SA02 Machine-readable Data Not Required for the EMA...Really?

David Izard

Source category: Submissions & Agencies

Author collections: David Izard

PHUSE · 2019Paper SA03PHUSE EU Connect 2019

SA03 ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements

Marianne Caramés

Source category: Submissions and Agencies

Author collections: Marianne Carames

PHUSE · 2019Paper SA03PHUSE US Connect 2019

SA03 High-quality Study Data Standards for Submission

Majdoub Haloui; Ellen Asam

Source category: Submissions & Agencies

Author collections: Majdoub Haloui · Ellen Asam

PHUSE · 2019Paper SA04PHUSE EU Connect 2019

SA04 Processing Big Data from Multiple Sources

Berber Snoeijer; Vijay Pasapula

Source category: Submissions and Agencies

Author collections: Berber Snoeijer · Vijay Pasapula

PHUSE · 2019Paper SA04PHUSE US Connect 2019

SA04 Submission of Software Programs to Regulatory Agencies

Maria Dalton

Source category: Submissions & Agencies

Author collections: Maria Dalton

PHUSE · 2019Paper SA05PHUSE US Connect 2019

SA05 Approach of Programming Production Harmonized with Submission

Chengxin Li

Source category: Submissions & Agencies

Author collections: Chengxin Li

PHUSE · 2019Paper SA05PHUSE EU Connect 2019

SA05 How Metadata Can Help Drive the Creation of Tables, Figures and Listings

Judith Goud; Stephen Castellano

Source category: Submissions and Agencies

Author collections: Judith Goud · Stephen Castellano

PHUSE · 2019Paper SA06PHUSE US Connect 2019

SA06 Developing SEND for CBER – Collaborative Workstream Initiative

Lisa Lin; Susan Dehaven

Source category: Submissions & Agencies

Author collections: Lisa Lin · Susan DeHaven

PHUSE · 2019Paper SA06PHUSE EU Connect 2019

SA06 Integrated Data and Document Anonymisation for Efficient Data Sharing

Ali Dootson; Cathal Gallagher

Source category: Submissions and Agencies

Author collections: Ali Dootson · Cathal Gallagher