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Introduction to Data Management
Categories:
Pharmaceutical
Understand the importance of data management and the role of the data management team within the clinical research process.
What Is The Course About?
This course is suitable for everyone who is new to the industry or is working in a support role within or alongside a Data Management team.
By the end of this course, you will be able to:
- Recognise the importance of data management to the success of the clinical trial.
- Understand how the data management team interacts with other functions in the process
- Understand the importance of study design and the setting up of good data management
procedures and documents
- Understand the importance of quality data collection and data cleaning processes
The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.
Course Programme:
Welcome & Introduction
Overview of the Drug Development Process
- Phases of Drug Development
- Trial Design
The Role of Data Management
- What is Data Management?
- History
- Skills
- Interaction with Clinical Research and Statistics
Data Management Procedures
- Process Overview
- Tracking
- Monitoring
- Data Entry
- Data Validation & Query Management
- Coding / Laboratory Data
- Data Quality
Workshop Sessions
- CRF design concepts
- Reviewing clinical data
The Impact of ICH GCP
- What is ICH GCP?
- GCP for data management
- SOPs
Group Discussion
- Responsibilities of the secretary / administrator
- The study master files / checklist
Course Dates
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Location
Distance (approx)
Course Start Date
No. Days
Web price ex.VAT
Course Status
London
3 miles
Fri 05 Dec 08
1
£590
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Key Details
Provided by:
Rostrum Training Solutions Limited
Duration
1 day
£590
per delegate