Data Management for Clinical Researchers

Hosted at: The Institute of Clinical Research Training Suite

Starts On: June 10, 2020

Finishes: June 10, 2020


CPD Points

The Course

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

Course Documentation

To apply for this course, prices are dependent on your membership status:
Acceptance by WorldPay ensures that your place is booked and guaranteed
To pay by invoice please contact ICR on 01628 501700
Guest ICR Member ICR Member (Academic)
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£550.00 £550.00