PharmaSchool: Understanding Data Management in Clinical Trials

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTM010

Enquire about course | Previous Feedback

Duration: 1 Day

The Course is designed to equip the delegate with an understanding of the key components of data management of clinical trials. This understanding includes the documents, the process and the terminologies.
The course is designed to give an overview of the entire data management process, focusing on how to perform optimal data cleaning, which starts from designing a good CRF, implementing a robust Data Management Plan, learning about the different types of data checks that can be performed and understanding why we need to collect quality data. The delegates will learn how to proactively perform ongoing data cleaning and understand how each member of the trial team is involved in this process.

Outline Agenda

Overview of the process

Components of data management
Documents and processes

CRF Design 

Design principles
What to include in a CRF

 Database design

Requirements of a clinical database
Database testing
Database Go-Live, post production changes

Data Management Plan

What should be included in a DMP
Who should review and approve

Validation Check Specifications

Types of checks: Automatic vs manual checks
What sort of checks should be performed
Testing validation checks

Data Cleaning and query production

Query process and query text
Diary Cards and Questionnaires
Reconciling lab data against CRF data, common problems with lab data cleaning
How to effectively manage the data cleaning process, utilising project management tools, team data review
What is a clean database, why do we need it and how to achieve it

Coding

Why we code, how we code
Common coding queries

Database close/lock

Database Close    
Blind review
Database

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Previous Course Feedback: Understanding Data Management in Clinical Trials
Customer: NHS Group
Number of Participants: 17
How well fulfilled were your personal objectives for this course?
Fully (82%)
Well (18%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (88%)
Fair amount (12%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (82%)
Fair amount (18%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.2
Participant Feedback :
Excellent course that explains exactly what we should be doing
Well timed course to give practical ideas and exercises
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