Data Management for Clinical Researchers

Hosted at: The Institute of Clinical Research Training Suite

Starts On: June 11, 2019

Finishes: June 11, 2019

10

CPD Points

The Course

This Course has been cancelled. Please contact the Office for more information.

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

We are unable to provide online booking to this course at the moment, if you need to attend this course please contact us at:

Tel: 01628 501701, Email: info@icr-global.org