THE COMMUNITY ARCHIVE

CDISC Papers and PresentationsPage 20

Browse practical discussions of clinical data standards, from collected observations to analysis datasets and supporting metadata. Use the more focused ADaM, SDTM and Define-XML collections to follow a particular stage of the workflow.

856 papers · Showing 381–400

PharmaSUG · 2021Paper AD-162PharmaSUG 2021

Generating Synthetic CDISC Clinical Trial Data.

Jose Lacal

Source category: Applications Development

PHUSE · 2021Paper DH11PHUSE US Connect 2021

Get Ready in One Click: Clean SDTM Datasets by Using Library Backend Rules

Annelies Van Zeveren; Sofie Stynen

Source category: Data Handling & Data Engineering

Author collections: Annelies Van Zeveren · Sofie Stynen

PHUSE · 2021Paper TT01PHUSE US Connect 2021

How the R Programming Language Handles the CDISC Library API

Joseph Hinson

Source category: Trends & Technology

Author collections: Joseph Hinson

PHUSE · 2021Paper SI08PHUSE EU Connect 2021

How to Be Traceable in ADaM

Angelo Tinazzi

Source category: Standards Implementation

Author collections: Angelo Tinazzi

PHUSE · 2021Paper DH04PHUSE EU Connect 2021

How to Handle Large Data Volumes in SDTM Using Continuous Glucose Monitoring as an Example

Ari Siggaard Knoph; Martin Gram

Source category: Data Handling & Data Engineering

Author collections: Ari Siggaard Knoph · Martin Gram

PHUSE · 2021Paper DS08PHUSE US Connect 2021

Industry Metrics for Extensions of CDISC Terminology

Sergiy Sirichenko

Source category: Data Standards and Governance

Author collections: Sergiy Sirichenko

PHUSE · 2021Paper DS04PHUSE EU Connect 2021

Introduction to Handling Efficacy Data in CDISC Standard Datasets

Kate Booth

Source category: Data Standards & Governance

Author collections: Kate Booth

PHUSE · 2021Paper CT04PHUSE EU Connect 2021

Learnings Using R for Creating CDISC Data for Analysis and Reporting Purposes!

Gustav Söderström; Nicole Major

Source category: Coding Tips & Tricks

Author collections: Gustav Söderström · Nicole Major

PHUSE · 2021Paper DH05PHUSE US Connect 2021

Mapping Missing QRS Responses in the SDTM

Mahesh Minnakanti; Vinita Dora

Source category: Data Handling & Data Engineering

Author collections: Mahesh Minnakanti · Vinita Dora

PharmaSUG · 2021Paper MD-044PharmaSUG 2021

Multiple Successful Submissions of Medical Device Clinical Trial Data in the US and China using CDISC

Phil Hall; Tikiri Karunasundera; Subendra Maharjan; Vijaya Vegesna

Source category: Medical Devices

Author collections: Phil Hall

PHUSE · 2021Paper DS02PHUSE US Connect 2021

Neurological Examination and Procedure Results in SDTM: Challenges and Solutions

Shivam Kumar

Source category: Data Standards and Governance

Author collections: Shivam Kumar

PharmaSUG · 2021Paper FDA-006cPharmaSUG 2021

OBE update in CDISC

Jiang (Jessica) Hu

Source category: FDA Tuesday

PHUSE · 2021Paper SA03PHUSE EU Connect 2021

Preparing PK/PD ADaM Datasets and eCRTs Data Package for FDA Submission

Junying Zhang

Source category: Submissions & Agencies

Author collections: Junying Zhang

PHUSE · 2021Paper RW04PHUSE EU Connect 2021

Real-world Data, CDISC SDTM, HL7 FHIR and the Future of Regulatory Submissions

Jozef Aerts

Source category: Real-world Evidence

Author collections: Jozef Aerts

PHUSE · 2021Paper CT01PHUSE EU Connect 2021

SAS Formats On The Fly Using ADaM Datasets

John Hendrickx

Source category: Coding Tips & Tricks

Author collections: John Hendrickx

PHUSE · 2021Paper ML10PHUSE US Connect 2021

SDTM Mapping and Conversion Using NLP

Eric Weising

Source category: Machine Learning & Connected Health

Author collections: Eric Weising

PHUSE · 2021Paper DS05PHUSE US Connect 2021

SDTM, ADaM and Database Normal Forms Implementation

Andrii Borzenkov

Source category: Data Standards and Governance

Author collections: Andrii Borzenkov

PHUSE · 2021Paper DS06PHUSE US Connect 2021

Standing Room Only Presentation: DS06: CDISC Analysis Results Standard

Bess LeRoy

Source category: Data Standards and Governance

Author collections: Bess LeRoy

PHUSE · 2021Paper RS02PHUSE US Connect 2021

The Case for Pandemic-disrupted Studies and Challenges Implementing CDISC and FDA COVID-19 Guidelines for NDA Submissions

Vidya Muthukumar

Source category: Regulatory Environment

Author collections: Vidya Muthukumar

PharmaSUG · 2021Paper SI-173PharmaSUG 2021

The Tortoise and the Hare – Lessons Learned in Developing ADaM Training

Alyssa Wittle

Source category: Strategic Implementation

Author collections: Alyssa Wittle