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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.

• 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

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