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
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
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
User Acceptance Testing (UAT)
- Introduction to UAT
- Need for UAT
- Aim of UAT
- When to do UAT
- Main steps involved in a UAT
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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