Migration Summary - Content

	Event Date
PHUSE Virtual CSS 2020	21 September 2020 - 23 September 2020
A Sneak Peek at the 2020 US Virtual Interchange	1 September 2020 - 1 September 2020
QRS "Office Hours"	27 August 2020 - 27 August 2020
CDISC for Newcomers (Virtual - Japan)	25 August 2020 - 25 August 2020
CDISC for Newcomers (Virtual; Japanese)	29 July 2020 - 29 July 2020
Leveraging Clinical Research Data Standards in Academia: What’s in it for Me?	28 July 2020 - 28 July 2020
Introducing the CDASH eCRF Project + CDISC Standards for Animal Rule Studies	21 July 2020 - 21 July 2020
CDISC for Newcomers (Virtual)	15 July 2020 - 15 July 2020
QRS Updates: Logically Skipped Items, EVAL and More	14 July 2020 - 14 July 2020
CDISC for Newcomers (Virtual; Mandarin)	9 July 2020 - 9 July 2020

Newsletter Article

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CDISC and PhUSE Implementation Primer Project
CDISC at PharmaSUG	Second Quarter 2019
CDISC Certification is Here!	Fourth Quarter 2020
CDISC China Coordinating Committee (C3C) Members Reunion at DIA China
CDISC COVID-19 Resources: Impact Report
CDISC Education in Uganda
CDISC Education Receives IACET Accreditation
CDISC Education: The Many Ways to Advance Your Standards Knowledge
CDISC EU Interchange 2021
CDISC European Coordinating Committee (E3C) Update

FAQ

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	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

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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

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CDISC Library API Documentation

CDISC Library Archive - Q1 2020 - Preview

CDISC Library Benefits

CDISC Library Reports

CDISC Library User Contacts

CDISC Organization & Values

CDISC PRM Toolset v1

CDISC Strategic Plan

CDISC User Networks

CDISC 新来者 - 学术研究者

News

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SEND Virtual Meetings: Public Broadcast Hosted by FDA

Trial Master File Reference Model Group Officially Affiliates with CDISC

Updated common protocol templates align clinical trial objectives, endpoints

Veeva’s Dan Crawford Elected Chair of CDISC Advisory Council

Vulcan FHIR® Accelerator Connects CDISC, HL7, and ICH M11 in a Project to Digitize Exchange of Clinical Research Protocols

Testimonials

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	Quote
SDTM Theory and Application	It was really a good training by a highly exper
SDTM Theory and Application	I found the whole course to be extremely useful
SDTM Theory and Application for Medical Devices	Even despite challenging technical issues in th
SDTM Theory and Application for Medical Devices	SDTM modeling for topics related to medical dev
SEND Implementation	The overall structure of the training was excel
SEND Implementation	The course was very comprehensible for people w
SEND Implementation	I found this course very informative and helpfu
SEND Implementation	The whole course was a great experience.
SEND Implementation	I liked having the implementation guide summari
SEND Implementation	I enjoyed learning about the different domains

News Link

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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

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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

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Webinar

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CDISC Public Webinar Series - Standards Updates and Additions - CDAD TAUG v1.0

CDISC Public Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates

CDISC Public Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates - Q1 2018

CDISC Public Webinar Series - Standards Updates and Additions - SDTM v1.7 Public Review

CDISC Public Webinar Series - What's New, What's Next

CDISC Public Webinar Series - What's New, What's Next - Broadcast #2

CDISC Public Webinar: Package 36 Controlled Terminology Publication Update/Package 37 Public Review

CDISC Public Webinar: Type 1 Diabetes Program Kick Off

CDISC Standards and Real-World Data

CDISC Standards Public Webinar - T1D Pediatrics and Devices Scoping Results Webinar

Therapeutic Area Version

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Schizophrenia Therapeutic Area User Guide v1.0

Schizophrenia Therapeutic Area User Guide v1.1

Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Traditional Chinese Medicine - Coronary Artery Disease-Angina Therapeutic Area User Guide v1.0

Traumatic Brain Injury Therapeutic Area User Guide v1.0

Traumatic Brain Injury Therapeutic Area User Guide v1.1

Tuberculosis Therapeutic Area User Guide v1.0

Tuberculosis Therapeutic Area User Guide v2.0

Vaccines Therapeutic Area User Guide v1.0

Vaccines Therapeutic Area User Guide v1.1

Standard Version

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Exchange Mechanism 1.0

Exchange Mechanism 1.0.2

Glossary v10.0

Company

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	Membership Level	Company Address
Blueprint Medicines Corporation	Platinum	45 Sidney Street Cambridge, MA 02139 United States
Boehringer Ingelheim Pharmaceuticals	Platinum	United States
Bristol-Myers Squibb	Platinum	311 Pennington-Rocky Hill Road Pennington, NJ 08534 United States
C&R Research	Gold	Gangnam-gu Seoul 06199 South Korea
Caidya	Platinum	3800 Paramount Parkway, Suite 100 Morrisville,, NC 27560 United States
Calian	Gold	770 Palladium Dr, 4th Floor Ottawa ON K2V 1C8 Canada
Canadian Center for Vaccinology	Gold	5850-5980 University Avenue Halifax NS B3k 6R8 Canada
Capish Nordic AB	Gold	22 Malmö Sweden
CDISC	Platinum	401 West 15th street Austin, TX 78701 United States
Celerion	Gold	22-24 Lisburn Road Belfast Northern Ireland Ireland