Migration Summary - Content

	Event Date
Public Training in Tokyo, Japan	2 September 2019 - 6 September 2019
A Sneak Peek at the New Features and Capabilities of ODM v2.0	25 July 2019 - 25 July 2019
Controlled Terminology Updates for Q3	9 July 2019 - 9 July 2019
Updates of CDISC Standards SDTM v1.7/SDTMIG v3.3 (Chinese Language)	28 June 2019 - 28 June 2019
Therapeutic Area (TA) Standards Overview	20 June 2019 - 20 June 2019
PharmaSUG 2019	16 June 2019 - 19 June 2019
SCDM Hyderabad Single Day Event	15 June 2019
PhUSE CSS Conference	9 June 2019
Public Courses in Osaka, Japan	3 June 2019 - 7 June 2019
Public Courses in Frankfurt (Sulzbach), Germany	3 June 2019 - 7 June 2019

Newsletter Article

Displaying 111 - 120 of 486

CDISC Names Industry Veteran David A. Evans President and CEO	Fourth Quarter 2020
CDISC Names Peter Van Reusel Chief Standards Officer
CDISC Partners with Gevity to Facilitate Use of Electronic Health Record Data in Clinical Research	Second Quarter 2020
CDISC PhUSE Roundtable
CDISC President and CEO Visits Stakeholders in Japan	First Quarter 2020
CDISC Publishes First Standard Using Traditional Chinese Medicine	Third Quarter 2019
CDISC Receives Grant from the Helmsley Charitable Trust to Develop Type 1 Diabetes-Related Data Standards
CDISC Releases CDASH v2.0
CDISC Releases Free User Guide to Amplify Data for Studies Pertaining to COVID-19	Second Quarter 2020
CDISC Releases Interim User Guide for COVID-19	Second Quarter 2020

FAQ

Displaying 1 - 21 of 21

	FAQ Category
Does CDISC SHARE contain external non-CDISC standards like SNOMED, LOINC?	SHARE
Academic Integrity	Education
Another Community Question	Knowledge Base
Anti-Discrimination Policy	Education
Appropriate Student Behavior	Education
Are there QRS-like instruments for which the collected data would not be stored in the FT, QS, or RS domains?	QRS
CDISC Learner Records	Education
CDISC Learner Records	Education
General CEU Information	Education
General Course Costs and Payment Policies	Education
General Prerequisites	Education
I am interested in contributing to CDISC SHARE. How do I join?	SHARE
Learner Record Privacy and Information Security Policy	Education
Successfully Completing a Course	Education
What is included in a QRS Supplement?	QRS
What is the connection between CDISC SHARE and Controlled Terminology?	SHARE
What is the history of CDISC SHARE?	SHARE
What is the infrastructure that enables CDISC SHARE?	SHARE
Will companies be allowed to develop/add their custom elements and extend the Foundational Standards?	SHARE
Will I find electronic case report form (eCRF) vendor metadata in CDISC SHARE?	SHARE
With what standards does CDISC SHARE comply, beyond CDISC?	SHARE

Video

Displaying 1 - 15 of 15

Benefits of Membership and Volunteering	No
CDISC - Brand	No
CDISC’s Impact in Asia	No
Controlled Terminology	No
Impact for Academic Researchers	No
Introduction to ADaM	No
Introduction to SDTM Implementation Guide	No
Introduction to SEND Implementation Guide	No
Regulatory Requirements	No
TAUG	No
Traceability	No
What Are CDASH and the CDASH Model	No
What are SDTM and SDTM Concepts?	No
What is the CDASHIG?	No
Whiteboard	No

Basic Page, Article

Displaying 111 - 120 of 220

Healthcare Link Vendors

Home Page - Temp

IMI Consortia Members

Implementations

In-Person Public Courses - 2021 China Interchange

In-Person Training

Innovations

Interchange Presentations

News

Displaying 61 - 66 of 66

Testimonials

Displaying 71 - 73 of 73

News Link

Displaying 1 - 42 of 42

CDISC’s New Chief Standards Officer Looks To Improve Standards At “Inflection Point”

Improving Serious Adverse Event (SAE) Reporting In Clinical Trials

A Pragmatic Method for Transforming Clinical Research Data from the Research Electronic Data Capture “REDCap” to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and Evaluation of REDCap2SDTM

A pragmatic tool for drug discovery

Accelerating drug development for Alzheimer's disease through the use of data standards

Achieving End-to-End Traceability

Alzheimer's treatments: What's on the horizon?

C-Path, CHDI and CDISC Announce Therapeutic Area User Guide for Huntington’s Disease

CDER Plots Pilot Project to Test CDISC Standard

CDISC launches COVID-19 research standards task force

CDISC Releases Data Management Guidance for COVID-19 Trials

CDISC US Interchange 2019 Keynote Address in Full

Clinical trials haven’t harnessed the digital revolution — TransCelerate’s latest initiative aims to change that

Clupea, KIT to establish Korea's 1st CDISC standard-based non-clinical big data platform

Cross-Stakeholder Collaboration: Advancing Research Through Common Protocol Templates

Data harmonisation for information fusion in digital healthcare: A state-of-the-art systematic review, meta-analysis and future research directions

Data Management Landscape is Still Changing, Are We Adapting Fast Enough?

Data Standards and ePRO Systems: A Road Less Travelled?

Data Standards in IDEA-FAST

EMA launches pilot project on analysis of raw data from clinical trials

End-to-end innovation in a regulated environment: applying spectral flow cytometry to clinical sample testing

FDA Binding Guidance: A Pivotal Milestone for CDISC Standards - Applied Clinical Trials

FHIR-to-CDISC Project Seeks to Facilitate Use of EHR Data in Clinical Research

Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up

Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy

How Standardization Can Be An Innovation In Clinical Outsourcing

How TransCelerate, Microsoft, Accenture, and CDISC are Working to Revolutionize Digital Data Flow

Making Data Speak the Same Language

New CDISC Standards Make Sites’ AE Reporting Easier

Presenting and Sharing Clinical Data using the eTRIKS Standards Master Tree for tranSMART

SDTM vs CDASH: Why You Need Both!

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical

The Turning Point for Clinical Research: Global Data Standardization

Therapeutic Area Data Standards for Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC)

TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability

TransCelerate BioPharma & CDISC Collaborate on SAE Data Collection Standard

TransCelerate BioPharma Commences Collaborative Development of a Novel Digital Data Flow Solution for Study Start-Up

Use of CDISC Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Using a therapeutic area user guide to multiply research investments

Using Health IT Data Standards to Boost Interoperability for Clinical Research

Knowledge Base

Displaying 1 - 56 of 56

A Short History of CDISC and SAS Transport Files	Yes
Are These Findings Just Repeats or Were They Scheduled at Time Points?	Yes
Assessing Causality	Yes
Avoiding SDTM and ADaM Dataset and Variable Name Conflicts	Yes
Can I add this variable to my SDTMIG dataset?	Yes
CDISC ADaM Phases, Periods, and Subperiods: A Case Study	No
CDISC-Annotated CRF Repository in Japanese	Yes
Changing Event Severity	Yes
Concept Maps for a Finding with Increasing Levels of Detail	Yes
Concept Maps for Adverse Events with Increasing Levels of Detail	Yes
Concept Maps for Substance Administration with Increasing Levels of Detail	Yes
Considerations for Using CDISC Standards in Observational Studies	Yes
Controlled Terminology: FAQs	Yes
Country Coding	Yes
Do I have to use the variable labels in the SDTMIG?	Yes
Does QNAM Need to Start with a Domain Code?	Yes
Domain vs. Dataset: What's the Difference?	Yes
Domains are Topic-based, Except When They're Based on Structure	Yes
How Do I Represent a Pre-specified Finding?	Yes
How should I represent whether a physical exam was performed in SDTM?	Yes
Implementation of COVID-19 Pandemic Impact Standards	No
IS Domain Scope Update for the SDTMIG v3.4: A Development History and the Difficulties of Standardizing Complicated Biological Processes	Yes
LOINC and the SDTM	Yes
Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library	No
Making Sense of the Various ADaM Documents	Yes
Oncology Disease Response (RS) Supplements	Yes
Pre-specified Events and Pre-specified Findings	Yes
Providing Review-Ready Results in SDTM	Yes
QA Knowledge Base	No
SDTM and CDASH: Why You Need Both	Yes
SDTM Structure Diagrams	Yes
SDTM Timing Variables for Pre-study Findings	Yes
Sex and Gender	Yes
Special Values: "MULTIPLE" and "OTHER"	Yes
Standardized Lab Units	Yes
Study Subject Site Transfers Example	Yes
Study Subject vs. Experimental Unit	Yes
Subject Visits and COVID-19	Yes
TAUG Examples of SDTM Domains	Yes
Test Academic	No
Test Academic - Masquerade	No
The Magic that Happens between CDASH and SDTM	Yes
Translating CDASH "PRIOR" and "ONGO" to SDTM relative timing variables	Yes
UCUM and CDISC Codelists	Yes
Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE)	Yes
Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis	Yes
Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms using a CDISC ODM API	Yes
Variable Metadata Has Changed in SDTM v2.0. How Does This Affect SDTMIG v3.4?	Yes
What Do We Mean When We Say Provisional?	Yes
When Did That Happen? A Brief Guide to Representing Timing in SDTM.	Yes
When Would I Use ISO8601 Interval Format?	Yes
Where Does My Lab Data Go in SDTMIG v3.4?	Yes
Why Are Certain SDTM Variables "Not for Use in Human Clinical Trials"?	Yes
Why is an Image like a Specimen?	Yes
Why Not Just Use SNOMED?	Yes
Why Would a Standards Development Organization Make Non-standard Variables Available on their Website?	Yes

Resource

Displaying 41 - 48 of 48

Webinar

Displaying 111 - 120 of 247

Controlled Terminology Updates for Q4 2022 - P52 publication/P53 public review

Controlled Terminology: P43 Publication and P44 Public Review

Controlled Terminology: P44 Publication, P45 Public Review, Paired Codelists, and CT Relationships

CORE Volunteer Onboarding Training Webinar

COSA Quarterly Spotlight - Q1 2023

COSA Quarterly Spotlight - Q2 2023

COSA Quarterly Spotlight - Q3 2023

COSA Quarterly Spotlight - Q4 2023

Therapeutic Area Version

Displaying 71 - 73 of 73

Standard Version

Displaying 111 - 120 of 138

SDTMIG v3.2 Conformance Rules v1.0

SEND Conformance Rules v3.0

SEND Conformance Rules v4.0

SEND Conformance Rules v5.0

SENDIG - Developmental and Reproductive Toxicology (DART) v1.0

Company

Displaying 111 - 120 of 423

	Membership Level	Company Address
Data4knowledge	Platinum	Byledet 15, Hovesdstaden 2820 Gentofte Denmark
DATAMAP GmbH	Gold	D-79111 Freiburg Germany
DF/Net Research, Inc.	Gold
DIcore Group, LLC	Gold	12 Wilkeshire Blvd Randolph, NJ 07869 United States
Digital Infuzion	Platinum
DNDi	Platinum	15 Chemin Camille-Vidart 1202 Geneva Switzerland
DOT WORLD CO., LTD.	Gold	Chuo-ku, Tokyo 104-0032 Japan
DP Clinical	Gold	9201 Corporate Blvd Suite 250 Rockville, MD 20850 United States
Droice Labs	Gold	424 West 33rd Street, 7th Floor – #7892 New York , NY 10001 United States
DT&CRO	Gold	15F, 126, Teheran-ro, Gangnam-gu Seoul 06234 South Korea