PharmaSchool: Data Management for CRAs and Project Managers

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: CTM007

Enquire about course | Previous Feedback

Duration: 1 Day

Description

The course is designed to give an overview of the entire data management process used in clinical trials, and looks at the parts of the process where the clinical team should be involved. This course will focus on data cleaning, giving the delegates an understanding of the different types of data checks that can be performed and the query process.

Who is it suitable for?

Anyone involved in the management or conduct of clinical trials including

CRAs/Monitors
Project Managers
Trial Coordinators
Research Managers
Investigators
Site Staff
Data Managers who are new to the role


Course Content:

Data Management Set-up

CRF Design 
Database design
Data Management Plan
Edit/Validation Check Specifications Types of checks
Manual/automatic checks
Query text
Testing edit checks


Project Documentation

CRF Receipt & Data Entry

CRF Storage & Tracking
Pre-entry review
Data Entry 

Data Cleaning and Query Production

Query process
Data Handling Conventions

Coding 

Why we code
Common coding queries

Lab data 

Checking lab data against CRF data
Common problems with lab data cleaning

Quality Control 

Types of QC
When to do QC
What is a clean database

Database close/lock

Database Close process
Blind review process
Database Lock


Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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Previous Course Feedback: Data Management for CRAs and Project Managers
Customer: Pharma
Number of Participants: 18
How well fulfilled were your personal objectives for this course?
Fully (89%)
Well (11%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (89%)
Fair amount (11%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (83%)
Fair amount (17%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.1
Participant Feedback :
Just what I needed, really needed to know this for a long time
Well structured and very useful
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