Course Details

One day classroom course with a mix of presentations and workshop sessions

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. By the end of this course participants will be able to:

• Describe the process of data cleaning
• Identify the different types of data checks that can be performed
• Outline the data query process.

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

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