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10-Jun-2020 - 10-Jun-2020

J21 Data Management for Clinical Researchers

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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Course Details

Are you a clinical researcher who has to review and approve data management plans, but find yourself struggling to know what you should be looking for?  Do you have to select a Data Management vendor but don’t know how to evaluate their capabilities?  In this course we will explore data management terminology, data management plans, coding and (e)CRFs so that you can work more effectively with data management specialists.

Learning Objectives

 

• Understand clinical data management terminology

• Have a good understanding of data management plans, coding and design of (e)CRFs

• Communicate effectively with data management specialists within a clinical project team

Course Outline  

Data Management basics

• Objectives of data management

• Regulatory background

• Quality of data

• Computer systems

 

Data capture

• Design of (e)CRFs 

• Data standards – CDISC / CDASH

• External data – labs, Serious Adverse Event data

 

Data Management plans

• Flow of data (paper and electronic)

• Data validation – queries

• Links to risk-based monitoring

 

Coding of medical terminology

• Purpose of coding

• Adverse events – MedDRA

• Concomitant medications

• Medical history

 

Further topics

• Data privacy

• Submission data sets

• Data sharing

• The future of data management