CDISC Library

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ADAKIEP Composite Endpoint
ADaM ADSL Dataset
ADaM BDS of Changes in Weight and/or Body Mass Index (BMI)
ADaM BDS for Average Glucose Measurements
ADaM BDS for time glucose measurements in range
ADaM Subject-level Analysis - ADSL Dataset
ADaM Basic Data Structure (BDS) using CRIT
ADaM Basic Data Structure (BDS) using PARAMCD
ADEXSUM Exposure
ADGFR Composite Endpoint
ADSL Endpoint
ADSL Composite Endpoint
Adverse Events (AE) with Device Event Reporting aCRF
All-cause Death
Analysis of Days Alive and Out of Hospital Composite Endpoint
Assay Kit and Properties
Background Heart Failure Maintenance Medications aCRF
Body Sites of Psoriasis Involvement at Baseline
Body Sites of Psoriasis Involvement at Baseline aCRF
Body Surface Area of Involvement (BSA)
Calculated Dose
Cardiac Surgery as an Acute Kidney Injury Risk Factor
Concomitant Insulin Treatment 
Death
Death aCRF
Device Event Reporting aCRF
Device Exposure aCRF
Device Identification aCRF
Device Identification    
Device Setting that are Changeable   
Devices Used by Subjects to Manage Diabetes aCRF
Diabetes Complications aCRF
Diabetes Device Generated Messages or Alarms  
Diabetes Diagnosis
Diabetes History 1
Diabetes ADSL Dataset
Diabetic Ketoacidosis Adverse Events
End-Stage Renal Disease
Fixed Device Properties and Settings 
Glomerular Filtration Rate 1
Glomerular Filtration Rate 2
Heart Failure Background Maintenance Medications
Heart Failure Lab Tests
Heart Failure Medical History
Heart Failure Medical History aCRF
Historical Start Date of Menstruation aCRF
History of Menarche 
History of  Autoimmune Disease  (other than Diabetes) aCRF
Hospitalization for Heart Failure
Hypoglycemia aCRF
Hypoglycemic Blood Glucose 1
Hypoglycemic Last Meal 1
Identification of Target Lesions and Measurements aCRF
Insulin Exposure aCRF
Japan CCCIDM SMIS: Dental Clinic Visit
Japan CCCIDM SMIS: Electrocardiogram (ECG)
Japan CCCIDM SMIS: Laboratory Data
Japan CCCIDM SMIS: Medical History, Family History, and Age of Symptom Onset
Japan CCCIDM SMIS: Smoking
Japan CCCIDM SMIS: Vital Signs
Laboratory Results Collected for each Diabetic Ketoacidosis Event
Meal Tolerance Testing aCRF
Menarche During a Study 
On-Study Crohn's Disease Background Medication, Non-study Drugs
On-Study Crohn's Disease Background Medication, Non-study Drugs aCRF
Orchidometer Examination aCRF
Pancreatic Adenocarcinoma Cancer Genomic Findings
Pancreatic Cancer ADTTE Survival and Duration of Follow-up
Pancreatic Cancer Cachexia
Pancreatic Cancer Laboratory Findings 
Pancreatic Cancer Medical History aCRF
Pancreatic Cancer Pathology Report 
Pancreatic Cancer Primary Tumor Characteristics
Pancreatic Cancer Radiation Therapy aCRF
Pancreatic Cancer Radiation Therapy 
Pancreatic Cancer Stent Placement
Pancreatic Cancer Study Treatment Infusion aCRF
Pancreatic Cancer Study Treatment Infusion 
Pancreatic Cancer Surgical History
Pancreatic Cancer Surgical History aCRF
Pancreatic Cancer ADSL Dataset
Pancreatic Cancer Body Composition Measurements
Pancreatic Cancer Ki67 Microscopic Findings
Pancreatic Enzyme Replacement Therapy
Pancreatic Neuroendocrine Cancer Genomic Findings
Patient Global Impression
Phototherapy Administration
Plaque Psoriasis Medical History aCRF
Population PK - Multiple Subjects, Multiple Studies
Prior Crohn's Disease - Dependency on Corticosteroid Treatments aCRF
Prior Phototherapy
Prior Psoriasis Treatments aCRF
Prior Treatments and Vaccination History
Proteinuria
Psoriasis Diagnosis
Renal Death 1
Renal Replacement Therapy
Renal Replacement Therapy 1 aCRF
Renal Replacement Therapy aCRF
Self-Monitoring Blood Glucose aCRF
Sequence Rearrangement Fusion
Serum Creatinine and eGFR
Short Variation Insertions and Deletions
Start Date of Menstruation During a Study aCRF
Static Physician Global Assessment
Target Lesion Assessment
Testicular Volume
Tolerance Test 3
Transthoracic Echocardiography, MUGA Scan
Treatment Dispensed and Returned
Treatment Dispensed and Returned - Combination Drug
Tumor Mutation Burden
Tumor Specimen Collection and Handling 
Unplanned Healthcare Visits for Heart Failure 
Urine Protein 1
Urine Protein 2
Vaccination History aCRF
Variable Number of Tandem Repeats
VAS for Itching and Quality of Life
 Diabetic Ketoacidosis - Device In-Use  At Time of Event aCRF
 Diabetic Ketoacidosis Adverse Events aCRF
 Pancreatic Cancer Stent Placement aCRF

Event

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Event Date
Navigating the CDISC Learning System and Our Many Training Offerings -
Clinical Data e-Submission Updates in China -
CDISC Certification Launch -
PHUSE EU Connect -
Introducing the Analysis Results Standard: Project Start Up and Call for Volunteers -
Public Courses - 2020 US Virtual Interchange -
Introducing the Next Generation CDISC Library -
Linking Data in SDTM -
Type 1 Diabetes Pediatrics and Devices Publication -
CDISC for Newcomers (Virtual) -

Newsletter Article

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C3C Members at PharmaSUG China
C3C Upcoming Hands-on Workshop on NMPA eSub Datasets Validation
C3C Update
Call for Volunteers: SDTM Variable Definitions Sub-Team – Phase 2 Fourth Quarter 2019
Calling All Open Source Developers Third Quarter 2019
CDASH-SAE v2.0 Face-to-Face Team Meeting First Quarter 2020
CDISC 360 Featured Prominently at US Interchange Fourth Quarter 2019
CDISC 360 has Launched Second Quarter 2019
CDISC 360 is Rolling Strong Third Quarter 2019
CDISC 360 Project

FAQ

Video

Basic Page, Article

News

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China’s Center for Drug Evaluation of the National Medical Products Administration Commits to CDISC Standards
Danish Medicines Agency Requires CDISC Format for Assessment of Marketing Authorization Applications and Variations
Embleema and CDISC Partner to Develop Standards for Cell and Gene Therapy Product Monitoring
EORTC Quality of Life measures integrated in CDISC
Global Public Health Data Standard to Enable Vaccine Certification Interoperability
Helmsley Charitable Trust Commits $5.4 Million to CDISC to Transform Data Standards for Clinical Research
ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology
Korean CDISC Coordinating Committee Launched at 2019 Korea Summit
Lindus Health and CDISC Collaborate on Innovative AI Initiative to Standardize Clinical Trial Data for Accelerated Research
Linking Collaborative Committee Clinical For Informatization In Diabetes Mellitus (CCCIDM) Self-managed Item Sets (SMIS) To The CDISC Study Data Tabulation Model (SDTM) V3.4

Testimonials

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Quote
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The instructor was very nice and easy to unders

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The course was really clear, even for a newbie

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Structured overview (from beginning/starting po

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Very comprehensible.

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Very well presented course with sufficient numb

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The instructor followed the schedule to finish

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The instructor did a great job explaining what

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The instructor clearly has experience with Defi

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The course was the right level of detail for my

Huge Difference for Programming

It makes a huge difference for programming when

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
Advancing Vision 2030: SCDM and CDISC Strengthen Their Collaboration for the Clinical Data Community
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
CDISC US Interchange 2019 Keynote Address in Full
CDISC's New 360i Helps Move Trial Design From Manual To Modern
CDISC’s 2025 AI Innovation Challenge
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
Powering Standards With Code: The Role Of Open Source In CDISC 360i
Powering Standards With Code: The Role Of Open Source In CDISC 360i
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
Webinar Recap: Accelerating Medical Device Trials with Data Harmonization

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
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
Deciding When to Use Phase, Period, and Subperiod 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
Guideline on When to Use AP-QRS Domains vs. QRS Domains for QRS Instruments Related to Associated Persons Yes
How Do I Represent a Pre-specified Finding? Yes
How should I represent whether a physical exam was performed in SDTM? Yes
How to Avoid ADaM Dataset and Variable Name Conflicts When Creating SDTM Domain and Variable Names 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 "study subject" Instead of "study participant"? 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

Webinar

Therapeutic Area Version

Standard Version

Company

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Membership Level Company Address
Astrix Technology Gold

125 Half Mile Rd
Suite 200
Red Bank, NJ 07701
United States
Asymchem Clinical (Clin-nov) Gold

Room 1805, Building C1, Yicheng Center, Changchunqiao Rd. 11, Haidian
Haidian Qu
Beijing Shi, 100190
China
Atorus Research Gold

3553 West Chester Pike #315
Newton Square, PA 19073
United States
Avenzo Therapeutics Gold

12707 High Bluff Drive, Suite 200
San Diego, CA 92130
United States
Avidity Biosciences Gold

10578 Science Center Dr. Suite 125
San Diego, CA 92121
United States
Axtria Gold

300 Connell Drive, 5th Floor
Berkley Heights, NJ 07922-2781
United States
Basilea Pharmaceutica Ltd. Gold
Bayer Healthcare Platinum
BeiGene Inc. Platinum

United States
Beijing BioVoice Technology Co., Ltd. Gold

United States

Courses

Instructors

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Zhijun (Stanley) Wei

Restricted

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2016 Europe Interchange Presentations
2016 International Interchange Presentations
2016 Japan Interchange Presentations
2017 China Interchange Presentations
2017 Europe Interchange Presentations
2017 International Interchange Presentations
2017 Japan Interchange Presentations
2018 China Interchange Presentations
2018 Europe Interchange Presentations
2018 Japan Interchange Presentations
2018 US Interchange Presentations
2019 China Interchange Presentations
2019 Europe Interchange Presentations
2019 Japan Interchange Presentations
2019 US Interchange Presentations
2019 US Interchange Presentations
2020 Europe Interchange Presentations
2020 Japan Interchange Presentations
2020 Technicon - Americas
2020 Technicon - Asia-Pacific
2020 Technicon - EMEA
2021 Technicon
CDISC 360
CDISC 360
CDISC Standards from the Start at ARO Council
CDISC/Microsoft Industry Stakeholder Workshop
Education - India Price Sheet for Online Courses
Education eBlast Host
Frankfurt 2017 Training Redirect
IntraChange 2017
President and Chief Executive Officer
QA Restricted
Send F2F
SHARE Exports (Safe)
Standards
Summer 2017 IntraChange
Test Redirect Link
Test Restricted
Test Vimeo - Static Embed
Working Group Meeting 2018

Team

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Published
Merson Laura Blue Ribbon Commission Yes
Misawa Hidetoshi Blue Ribbon Commission Yes
Nadolny Patrick Board of Directors Yes
O Callaghan Jennifer Blue Ribbon Commission Yes
O Donnell Rhona Board of Directors Yes
Okada Mihoko Board of Directors Yes
Palm U lo Blue Ribbon Commission Yes
Picone Maria Blue Ribbon Commission Yes
Pochon Phil Blue Ribbon Commission Yes
Pulkstenis Erik Board of Directors Yes
Structure Not Ready