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CDISC online training offerings include courses and webinars. Online courses are divided into individual modules, allowing you to pace yourself throughout the course. Webinars address industry hot topics, along best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts.

CDISC is implementing a new online learning platform to better serve your training needs. The new platform will be available 3 December 2018. Until then, our online training system is unavailable. We apologize for the inconvenience and thank you very much for your patience.

 

Online Course Offerings

Name

Description

CDISC - ADaM001 - Introduction to ADaM

 

ADaM Module 1 covers the goals and mission, and introduces the fundamental principles of the Analysis Data Model, ADaM. (Language: English) (Course Length: 13:44)

 

CDISC - ADaM002 - ADaM Traceability, Rules and Best Practices

 

ADaM Module two defines and illustrates the concept of traceability, and presents the ADaM rules and best practices for creating variables and datasets. (Language: English) (Length: 34:36)

 

CDISC - ADaM003 - Design Concepts in ADaM

 

ADaM Module 3 describes the treatment concepts from an analysis perspective with an emphasis on the types and timing of treatments. (Language: English) (Length: 29:21)

 

CDISC - ADaM004 - Subject Level Analysis Dataset

 

 

ADaM Module 4 discusses the ADaM data structure Subject Level Structure and how the dataset is used to provide a source for denominators for populations of interest, stratification variables, and other important subject subgroups. (Language: English) (Length: 15:43)

 

 

CDISC - ADaM005 - Introduction to the Basic Data Structure

 

 

ADaM Module 5 discusses the Basic Data Structure or B-D-S, which is designed with the majority of analyses in mind. The structure is one or more records per subject per analysis parameter, per analysis time point, if applicable. (Language: English)

 

 

CDISC - ADaM006 - BDS Concepts

 

ADaM Module 6 will discuss why we have analysis concepts instead of using SDTM variables. (Language: English)

 

CDISC - BRIDG001 - Introduction to BRIDG

 

This module provides an overview of the BRIDG model regarding its scope, stakeholders and governance. Additionally, it provides a high level view into the organization of the model and introduces the various sub-domains of clinical research in the model.(Language: English) (Length: 54:49)

 

CDISC - BRIDG002 - BRIDG Activities

 

This module focuses on the BRIDG Activity class and its four subclasses: Defined, Planned, Scheduled and Performed. It provides examples for the key attributes of each kind of activity class and further explains the associations between the classes. (Language: English)(Length: 35:28)

 

CDISC - BRIDG003 - Common Sub-Domain

 

This module provides an in-depth review of the Common sub-domain of the BRIDG model. It explores the core concepts of entities associated with protocol-driven research - Person, Subject, Organization, Drug, Device and all the related classes. (Language: English) (Length: 20:25)

 

CDISC - BRIDG004 - Protocol Representation Sub-Domain

 

This module provides an in-depth review of the Protocol Representation sub-domain of the BRIDG model. It focuses on two main areas – Study Characteristics and Trial Design. Concepts from CDISC Trial Design Model, TDM, are represented in this sub-domain. (Language: English) (Length: 38:47)

 

CDISC - BRIDG005 - Study Conduct Sub-domain

 

This module provides an in-depth review of the Study Conduct sub-domain of the BRIDG model. It focuses on the performed activities, observations and observation results concepts of a study and provides attribute level examples for these three concepts. (Language: English) (Length: 27:00)

 

CDISC - BRIDG006 - Adverse Event Sub-Domain and Statistical Analysis Sub-Domain

 

This module provides an in-depth review of the Adverse Event sub-domain and an overview of the smaller Statistical Analysis sub-domain of the BRIDG model. Adverse Event includes safety issues involving people or products. (Language: English) (Length: 27:04)

 

CDISC - BRIDG007 - Data Types

 

This module provides an introductory overview on the HL7 Abstract Data Types standard. It mainly focuses on the types of complex data types leveraged in the BRIDG mode and provides few examples of some commonly used data types. (Language: English) (Length: 27:31)

 

CDISC - BRIDG008 - Constraints and Tags

 

This module provides an overview of the constraints and the tags, mapping tags, that are used in the BRIDG model. It specifically explains the various kinds of constraints and how they are represented in the BRIDG model. (Language: English) (Length: 19:50)

 

CDISC - BRIDG009 - Harmonization and Mapping

 

This module provides an overview of the BRIDG harmonization process. The focus here is to familiarize you with the harmonization artifacts and get you familiar with the process. It also reviews how the BRIDG mapping spreadsheet is used in that process. (Language: English) (Length: 22:01)

 

CDISC - CDASH001 - Introduction to CDASH

 

CDASH Module One covers the foundational concepts of CDASH, how it supports traceability in clinical research, its relationship to other CDISC standards and how to be create conformant CRFs. (Language: English) (Length: 34:07)

 

CDISC - CDASH002 - Header and Data Comments

 

CDASH Module 2 presents the data collection fields that are common to all case report forms, including identifiers and timing fields. It also presents information on collecting comments and other free text fields. (Course Length: 21:10) (Language: English)

 

CDISC - CDASH003 - Demographics

 

CDASH Module 3 describes the concepts that are collected in a Demographics domain, and the conventions for creating a Demographics CRF that conforms to CDASH best practices recommendations and supports traceability to the SDTM DM domain. (Language: English) (Length: 22:01)

 

CDISC - CDASH004 - CDASH Events Domains

 

CDASH Module Four covers the basic concepts for Events class domains and then the specifics of the Events domains published in CDASH V1.1. (Language: English) (Length: 31:28)

 

CDISC - CDASH005 - Interventions Domains

 

CDASH Module Five covers the basic concepts for Interventions class domains and then the specifics of the Interventions domains that are published in CDASH V1.1. (Length: 33:26) (Language: English)

 

CDISC - CDASH006 - Findings Domains

 

CDASH Module Six covers the basic concepts for Findings class domains and then the specifics of the Findings domains published in CDASH V1.1. (Language: English) (Length: 67:58)

 

CDISC - CDASH007 - Best Practice Recommendations

 

CDASH Module Seven covers the Best Practices for developing and designing case report forms, CRF, that are recommended in the CDASH Standard. (Language: English) (Length: 36:58)

 

CDISC - CDASH008 - Implementing CDASH in Your Data Stream

 

This module addresses good practices for implementing CDASH standards at the organizational level. It also presents information for creating non-standard data collection fields and non-standard CRF structures. (Language: English) (Length: 21:13)

 

CDISC - CT001 - Overview of Terminology

 

Controlled Terminology Module 1 covers a brief history of CDISC terminology, the primary objectives, and guiding principles, how terminology is developed and maintained, and the basics of how to find and use terminology, and request new terms. (Language: English)(Length: 27:03)

 

CDISC - CTJPN001 - Overview of Terminology Japanese Translation

 

Controlled Terminology Module 1 covers a brief history of CDISC terminology, the primary objectives, and guiding principles, how terminology is developed and maintained, and the basic of how to find and use terminology, and request new terms.(Language: Japanese)

 

CDISC - DEFINEXML001: Introduction to Define-XML

 

Define XML identifies how, and describes the primary components of, Define-XML relates to SDTM, SEND and ADaM. This module also focuses on how to access Define-XML specification and supporting files as well as navigating Define-XML specification. (Language: English) (Length: 40:56)

 

CDISC - PGx001 - Introduction to Pharmacogenomics Implementation Standards

 

Pharmacogenomics Module 1 provides a high level background on the PGx project and its underlying concepts. (Language: English) (Length: 25:43)

 

CDISC - PGx002 - Pharmacogenomics and Genetics (PGx) Standards Model

 

Pharmacogenomics (PGx) Module 2 describes the new domains and variables added to the SDTM model to support genetic and genomic, specimen and biomarker data.(Language: English) (Length: 37:25)

 

CDISC - PGx003 - Mapping Pharmacogenomics and Genetics

 

Through a series of use cases, Pharmacogenomics Module 3 illustrates how to identify and map molecular biology data to SDTM data structures. Hands-on exercises provide practice with these methods. (Language: English)(Length: )

 

CDISC - PK001 - Introduction to PK Analysis

 

Pharmacokinetics (PK) Module 1 is an introduction to the basic concept of pharmacokinetics (Language: English) (Length: 33:33)

 

CDISC - SDTM001A - An Introduction to the Study Data Tabulation Model

 

FREE COURSE: The CDISC standards, process, participants and an introduction to the Study Data Tabulation Model and it’s documentation set. (Language: English) (Length: 24:25)

 

CDISC - SDTM002A - SDTM Basics

 

This curricula contains the training and the assessment of SDTM002A. (Language: English) (Length: 29:33)

 

CDISC - SDTM003A - Basics of the SDTM Implementation Guide

 

This curricula contains the training and the assessment of SDTM003A. (Language: English) (Length: 24:26)

 

CDISC - SDTM004A - Special Purpose Domains: Demographics

 

Describes the purpose and organization of the Special Purpose domain: Demographics. (Language: English) (Length: 19:50)

 

CDISC - SDTM005A - General Observation Classes

 

An introduction to the General Observation classes as well as the Relationship and Trial Design domains and the variable types used in each. (Language: English) (Length: 31:06)

 

CDISC - SDTM006A - Timing and Grouping Variables

 

This module introduces the role of Timing and Grouping variables in SDTM. Timing variables are used to tell when an observation occurred either by actual date or time, a descriptor if an actual date or time is not available.(Language: English) (Length: 49:26)

 

CDISC - SDTM007A - Controlled Terminology

 

This module introduces the use of controlled terminology in SDTM. A definition is provided along with rules for controlled terminology usage. (Language: English) (Length: 27:12)

CDISC - SDTM008A - Interventions Domains

 

This module introduces the variables included in the Interventions General Observation Class. Details are provided for the 3 Interventions Domains - Exposure, Concomitant Medications and Substance Use. The role each domain is explained as well as how, when and why you would use the variables in each domain. Examples are provided to help solidify the student’s understanding of the material contained in each module. (Language: English) (Length: 27:15)

 

CDISC - SDTM009A - Events Domains

 

This module introduces the variables included in the Events General Observation Class. Details are provided for the 5 Events Domains - Adverse Events, Medical History, Disposition, Protocol Deviations, and Clinical Events. (Language: English) (Length: 33:17)

 

CDISC - SDTM010A - Findings Domains

 

Details are provided for 10 Findings Domains - Vital Signs, ECG, Labs, Inclusion-Exclusion, Physical Exam, Questionnaires, Subject Charactertistics, Drug Accountability, Microbiology and Pharmacokinetics. (Language: English) (Length: 61:54)

 

CDISC - SDTM011A - Findings About

 

Module 11 describes the Findings About domain along with five use cases. (Language: English) (Length: 20:10)

 

CDISC - SDTM012A - RELREC - Relating Records and Datasets in SDTM

 

Module 12 presents the Related Records or RELREC dataset. RELREC is used to show collected relationships between individual records for a subject, and relationships between whole domains. (Language: English) (Length: 15:31)

 

CDISC - SDTM013A - Supplemental Qualifiers

 

Supplemental Qualifiers allow us to add non-standard, sponsor-defined variables to our data in SDTM. This module presents the dataset structure that is used for Supplemental Qualifiers, the method for linking them to their related data, and examples. (Language: English) (Length: 23:07)

 

CDISC - SDTM014A - Creating Custom Domains

 

Module 14 presents the purpose of custom domains and how to create them. (Language: English) (Length: 13:31)

 

CDISC - SDTM015A - Trial Design

 

Module 15 presents the Trial Design domains in SDTM. Trial Design domains are a way to include information about the protocol in a standard structure that is useful in a data repository. (Language: English) (Length: 32:13)

 

CDISC - SDTM016A - Special Purpose Domains

 

Module 16 presents the Special Purpose domains for Comments, Subject Elements and Subject Visits. (Language: English) (Length: 20:56)

 

CDISC - SDTM017A - Define-XML

 

Module 17 covers the Define-XML file, including what information to include in the dataset, variable and value-level metadata and associated information. It focuses on the content rather than the xml programming necessary to produce the files. (Language: English) (Length: 31:36)

 

CDISC - SDTM019 - New Interventions Domains in SDTMIG v3.2

 

SDTM, Module 19 describes the interventions domains that were first published in SDTMIG v3.2 and provides examples of how they can be used. (Language: English) (Length: 24:03)

 

CDISC - SDTM020 - New Events Domains in SDTMIG v3.2

 

SDTM, Module 20 describes the events domain that was first published in SDTMIG v3.2 and provides examples of how it can be used. (Language: English( (Length: 8:11)

 

CDISC - TA001 - Overview of Therapeutic Area User Guides

 

FREE COURSE: TA User Guide 001 provides an overview of the structure of Therapeutic Area UGs. It describes concept maps and metadata, shows the relationship between foundational standards and TA User Guides, and also discusses how to review draft TA User Guides.(Language: English) (Length: 1:15:42)

 

CDISC - TA002 - Asthma User Guide

 

TA002 is intended to provide a better understanding of the asthma indication, how to read and interpret the concept maps, and how to manage asthma data through the lifecycle of a clinical study. (Language: English)(Length: 60:19)

 

CDISC - TA010 - Diabetes

 

FREE COURSE: Therapeutic Standards Area Module 10 is intended to provide a better understanding of the Diabetes indication, how to read and interpret the concept maps and SHARE metadata, and how to develop data structures for Diabetes data through the life cycle of a clinical study. (Language: English)(Length: 53:36)

 

CDISC - TA016 - Breast Cancer

 

FREE COURSE: Therapeutic Standards Area Module 16 is intended to provide a better understanding of the Breast Cancer indication, how to read and interpret the concept maps, and how to develop data structures for breast cancer data through the lifecycle of a clinical study.(Language: English)(Length: 67:08)

 

CDISC - TA018 - Dyslipidemia

 

FREE COURSE: Therapeutic Area Standards Module 18 is intended to provide a better understanding of Dyslipidemia, how to read and interpret concept maps, and how to develop structures for Dyslipidemia data through the lifecycle of a clinical study. (Language: English) (Length: 35:50)

 

CDISC - TA019 - Chronic Obstructive Pulmonary Disease

 

FREE COURSE: Therapeutic Area Standards Module 19 is intended to provide a better understanding of COPD, how to read and interpret concept maps, and how to develop structures for COPD data through the lifecycle of a clinical study.(Language: English)(Length: 87:29)

 

CDISC - TA023 - Malaria

 

FREE COURSE: Therapeutic Area Standards Module 23 is intended to provide a better understanding of how to model Malaria clinical research data using CDISC standards. (Language: English) (Length: 1:34)

CDISC - The Future of eClinical With CDISC

 

FREE COURSE: The Translational Research Informatics,TRI, center in Kobe, Japan, founded in 2002, is committed to the innovation of medical technologies by facilitating the transfer of basic medical research findings to clinical practice. (Language: Japanese)

 

CDISC Mini-Training: Associated Persons Domains - Who, What, When, Where Why, How?

 

Agenda: This installment in the CDISC Mini Training series covers the application of Associated Persons domains in studies and best practices for creating and submitting Associated Persons data (Duration: 55:32) (Language: English) (Original Date: Apr 23 2015) (Panelist: Alyssa Wittle)

 

CDISC Mini-Training: Automating Clinical Standards

 

Agenda: This installment in the CDISC Mini Training series covers the case for clinical data standards and clinical data standards automation, leveraging CDISC Standards automation and implementing a company metadata repository.(Duration: 68:50) (Language: English) (Original Date: 21 May 2015) (Panelists: Dan Kesack and Jim LaPointe)

 

CDISC Mini-Training: CDISC Mini-Training: Why is CDASH the way CDASH Is

 

You may provide feedback below. If you would like to access more CDISC live mini-training events, please visit the membership area of the CDISC website. (Language: English) (Length: 50:09)

 

CDISC Mini-Training: Deconstructing ADRS - Tumor Response Analysis Data Set

 

This installment in the CDISC Mini-Training series describes the experience of working with an already-existing data set used for the analysis of tumor responses. The focus will be on the ADaM implementation and lessons learned. (Language: English) (Length: 50:09)

 

CDISC Mini-Training: Ensuring USUBJID is Unique for an Individual in an Application

 

This installment in the CDISC Mini Training series covers best practices for ensuring that consistent single USUBJID value is assigned to each individual with data in an application. (Language: English) (Length: 81:01) (Original Date of Delivery: 12 FEB 2015) (Panelist: Monica Mattson, Mark Sullivan, and Gary Walker)

 

CDISC Mini-Training: EPOCH - What It Is and How to Handle It

 

Agenda: This installment in the CDISC Mini Training series covers the EPOCH Variable SDTM Trial Design History. The regulatory background of the variable and how to build epochs and arms from elements. (Language: English) (Duration: 44:54) (Original Date: Oct 22 2015) (Panelist: Diane Wold, Ph.D.)

 

CDISC Mini-Training: Null Flavors - A Tool for Handling Missing and Awkward Data v2

 

This installment in the CDISC Mini Training series describes null flavors. When a piece of data is not available in the expected form, a null flavor can be used to provide information on why it's missing or on how it may be available in an alternate form. (Language: English)

 

CDISC Mini-Training: Reference Time Points vs. Time Point Reference

 

Agenda: This installment in the CDISC Mini Training series covers relative timing vs. time points for collection. Topics include the key concepts of variables used in relative timing and collection time points. (Language: English) (Length: 37:44) (Original Date of Delivery: 07 APR 2016) (Panelist: Lauren Shinaberry and Jerry Salyers)

 

CDISC Mini-Training: Results Level Metadata: What, How and Why

 

This installment in the CDISC Mini-Training series provides an overview of results-level metadata. Panelists: Frank Dilorio and Jeffrey Abolafia. (Language: English) (Length: 01:19)

 

CDISC Mini-Training: SEND for Clinical Research Professionals

 

This installment in the CDISC Mini Training series covers the benefits of SEND and how the standard works with SDTM. The mini training will also compare non-clinical and clinical study conduct, designs, and data. Please note that CDISC members can access these trainings by visiting the Members Only Webinar Archive at CDISC.org. (Duration: 54:08) (Language: English) (Original Date: 10 DEC 2015) (Panelist: Gitte Frausing)

 

CDISC Mini-Training: Some Considerations When Designing ADaM Datasets

 

This installment in the CDISC Mini Training series focuses on the issues related to the many variables defined and recommendations on creating user-defined variables in the ADaM Implementation Guide. (Language: English)

 

CDISC Mini-Training: The Need for Human Intelligence in Assessing SDTM v2

 

This installment in the CDISC Mini-Training series describes why experienced people are required for study data compliance-assessment and remediation processes.(Language: English)

 

CDISC Mini-Training: The World of Standards: CDISC and Beyond

 

This installment in the CDISC Mini-Training series discusses the wider importance of using standards. Panelist: Kit Howard. (Language: English) (Length: 1:16)