CDISC for Newcomers (VIRTUAL Zoom)

• Describe the CDISC Standards Development process, standards models, implementation guides and therapeutic area user guides to recognize their value in clinical research.
• Identify individual CDISC standards to set the stage for implementation.
• Support the adoption of implementing CDISC standards early in the clinical research process.
• Interpret CDISC Therapeutic Area User Guides in order to implement them across foundational standards 
• Recognize how Define-XML organizes standards for as both machine-and human-readable metadata

Topic 1: What is CDISC?

Topic 2: Why Are Standards Needed?

Topic 3: Overview of Regulatory Requirements

Topic 4: Overview of CDISC Models

Topic 5: CDISC Connects Research Globally

Topic 6: Therapeutic Area User Guides

Topic 7: Data Exchange Standards

Topic 8: Implementing CDISC Standards

Topic 9: CDISC Library

Topic 10: How Does CDISC Work?

After purchasing a virtual training, you will automatically receive a Confirmation Email with the following:

• an order number
• link to the CDISC Learning Management System (LMS)

You can immediately access the online training materials in the LMS.

Within 24 hours, you will be assigned to your specific virtual Zoom seminar event.

You will receive a Training Booking Confirmation Email with the following:

• event details (including a Zoom meeting link)
• an iCal attachment

Please contact us if you do not receive these emails within 24 hours.

このコースを受講すると、次のことができるようになります

• Topic 1: CDISCとは？  
                  What is CDISC?
• Topic 2: なぜ標準が必要なのか？ 
                  Why Are Standards Needed?
• Topic 3: 規制要件の概要   
                  Overview of Regulatory Requirements
• Topic 4: CDISCモデルの概要   
                  Overview of CDISC Models
• Topic 5: CDISCは試験をグルーバルに結び付ける   
                   CDISC Connects Research Globally
• Topic 6: Therapeutic Area User Guides
• Topic 7: データ交換の標準   
                  Data Exchange Standards
• Topic 8: Traceability
• Topic 9: CDISCライブラリ   
                  CDISC Library
• Topic 10: どのように参加できるか？   
                   How Can You Get Involved?