CLINICAL DATA MANAGEMENT TRAINING
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INTORDUCTION

  1. Overview Of Data Management
  2. Data Acquisition

CASE REPORT FORM

  • CRF Desing And Development
  • Electonic Data Capture
  • Standard Operating Procedure
  • Data Privacy
  • Physical And Electronic Data Security
  • Electronic Data Capture Principles
  • Preparation And Preservation Of CRF
  • Completion Guidelines
  • CDM Presentation at investigator meetings
  • Prepare SAS analysis
  • datasets,tables,listings and figures as per specifications.
  • Map and migrate legacy datasets into CDISC SDTM and ADaM standard datasets.
  • Co-ordinate with the client and US-team for clarity of specifications,data issues,outlier etc

 

DATA STORAGE

  • Physical Storge

 

DATA ARCHIVAL

  • Database Validation ,Programming And Standards
  • Data Entry And Data Processing

 

DATA CLEANING

DATA TRANSMISSION

DATA MANAGEMENT

  • Dictonary Selection
  • Auto-Encoder
  • Safety Data Management And Reporting
  • Serious Adverse Event Data Reconciliation
  • Procedures
  • Assuring Data Quality
  • DATAbase Closure
  • Recommende standard oerating procedures
  • Clinical Data Archiving
  • Vendor Evaluation
  • Vendor Management

 

METRICS FOR CLINICAL TRIALS

  • Data Management Metrics
  • Cost
  • Time
  • Quality
  • Audit Of Clinical Trails

Choosing An Auditor

  • Planning The Audit
  • Conducting The Audit
  • Audit Checklist
  • Chronology Lists
  • Areas To Review
  • Regulatory Documentation
  • Clinical Documentation
  • CRF And Sourse Documentation Consistency
  • CRF Correlations
  • ADE Documentationand Reporting
  • Investigational Device Accountability Records
  • Special Challenges For Auditors
  • Using The Findings
  • The Audit Report

 

GLOBAL ISSUES

  • Introduction
  • Principles
  • Operational benefits of data interchange standards
  • Scientific benefits of data interchange standards
  • CDISC Standards
  • ODM –Operational Data Model

 

SDTM

  • ADaM–Analysis Dataset Model
  • Lab –Clinical Laboratory Data Model
  • Case Report Tabulation Data Definition Specificatio
  • Protocol Representation Standard
  • CDISC standards integration

 

CLINICAL TRIAL

  • Responsibilities of Sponsor
  • Post marketing surveillance
  • 21 CFR PART 11
  • Introduction
  • Electronic Records
  • Electronic Signatures

If you want to know more about Clinical Data Management Training do not hesitate to call +91-7774892805 or mail us on contact@intelogik.com

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