Preview to Lessons in CDM - Learners' Request

Clinical Data Interchange Standards Consortium (CDISC)

  • Introduction to CDISC
  • Need of CDISC
  • Origin of CDISC
  • Importance of CDISC
  • How does CDISC work
  • CDISC Standards:
  • Foundational or data content standards
  • Standard for Exchange of Nonclinical Data(SEND)
  • Protocol Representation Model (PRM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Study Data Tabulation Model (SDTM)
  • Analysis Data Model (ADaM)
  • Data exchange standards
  • Therapeutic areas

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Discrepancy Management 

  • Discrepancy Management - Introduction
  • Importance/Need of Discrepancy Management
  • Introduction to Discrepancy with examples
  • Generation of Discrepancies in Clinical trial
  • Identification of Discrepancies
  • Kinds of Discrepancies
  • System generated
  • User generated
  • Resolution of Discrepancies in:
  • EDC system
  • Paper-based study

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SAE Reconciliation

  • Definition of Serious Adverse Event (SAE)
  • Collection of SAE during Clinical trial
  • Introduction to SAE Reconciliation
  • Need for SAE Reconciliation
  • SAE Reconciliation -Method
  • Data checked during SAE Reconciliation
  • Points to consider before SAE Reconciliation


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User Acceptance Testing (UAT)

  • Introduction to UAT
  • Need for UAT
  • Aim of UAT
  • When to do UAT
  • Main steps involved in a UAT

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Data Manager

  • Introduction to Data Manager
  • Overview of Data Manager role in CDM
  • Tasks performed by Data Manager in the CDM process
  • Competencies & Skills required to become a Data Manager
  • Education required to become a Data Manager
  • Organizations where Data Managers can work


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Klinibytes Lessons




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Testimonials

Comments from the students/learners who have benefitted from our learning content

your videos helped me to get a job as a case handler two years ago! Now, I love the field and am being trained as a Domain specialist for IT teams! thank you!


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OMG this is one of the best videos i have seen on trial overview. I am not a medical or research person but working for a pharmaceutical company and wanted an overview. You explained it very well. Thanks a bunch


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