CDASH Bundle (Modules 1-8)

This course bundle contains the following training modules:

• CDASH001: Introduction to CDASH

• CDASH002: Header and Data Comments

• CDASH003: Demographics

• CDASH004: CDASH Events Domains

• CDASH005: Interventions Domains

• CDASH006: Findings Domains

• CDASH007: Best Practice Recommendations

• CDASH008: Implementing CDASH in Your Data Stream

Module 1:

Learning Outcomes:

• Describe the CDASH standard and how it supports traceability in clinical research and how it aligns with other CDISC standards

• Recognize the value of using CDISC controlled terminologies in CDASH implementation

• Create case report forms that are conformant to the CDASH standard

Language: English | Video Duration: 41:38 | CEUs: 0.1

Module 2:

Learning Outcomes:

• Identify “common” fields in CDASH study data

• Successfully implement core designations for header data

• Understand how to collect free text fields in CDASH

Language: English | Video Duration: 19:38 | CEUs: 0.1

Module 3:

Learning Outcomes:

• Recognize values that are collected in the DM domain and those that are not

• Identify the basic rules for collecting DM data in a way that conforms to CDASH and supports traceability to SDTM

• List the steps required to collect and tabulate RACE data in a regulatory submission

Language: English | Video Duration: 19:23 | CEUs: 0.1

Module 4:

Learning Outcomes:

• Successfully implement Events class domains in CDASH

• Recognize which variables can be used in Events class domains in CDASH

• Describe the purpose and rules for individual Events class domains in CDASH

Language: English | Video Duration: 13:08 | CEUs: 0.1

Module 5:

Learning Outcomes:

• Accurately describe the purpose and basic concepts of Interventions domains for data collection

• Apply basic CDASH principles to the creation of Interventions class CRFs

• Identify the fields that are needed for each CRF based on the Interventions class

• Successfully use timing fields correctly in CRFs based on the Interventions class

Language: English | Video Duration: 33:47 | CEUs: 0.1

Module 6:

Learning Outcomes:

• Successfully implement data in the Findings class domains in CDASH

• Determine variables that can be used in Findings class domains in CDASH

• Use controlled terminology to create variables and Prompts in Findings data collection

• Use timing fields correctly in Findings class domains in CDASH

Language: English | Video Duration: 63:37 | CEUs: 0.1

Module 7:

Learning Outcomes:

• Explain CDASH Best Practice Recommendations for creating CRFs

• Describe the importance of cross-functional review in creating CRFs

• Design CRFs that support high-quality data collection

• Explain the importance of using standard CRF libraries in CDASH

Language: English | Video Duration: 35:28 | CEUs: 0.1

Module 8:

Learning Outcomes:

• Describe basic principles of good cross-functional standardization

• Create data collection fields that do not exist in CDASH

• Create data collection fields that do not exist in SDTM

• Create custom domains in CDASH

Language: English | Video Duration: 19:42 | CEUs: 0.1