How to be an Effective Clinical Trials Administrator (CTA)
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Improve your performance as a Clinical Trial Administrator and learn how the latest EU Directive will affect your working procedures

What Is The Course About?
This course is aimed at Clinical Trial Administrators (CTAs) and support staff with little or no knowledge of clinical research processes. In particular, this course will provide background information on the regulation, processes and functions that link in with the role of the CTA. In addition, the changing regulatory environment in Europe will be discussed and especially, how Directive 2001/20/EC on GCP in Clinical Trials will affect working procedures.

By the end of the course, you will be able to:
- Understand the controls and regulations in the industry.
- Understand the role of Ethics Committees
- Understand the importance of Trial Master Files and Standard Operating Procedures
- Understand the importance of patient protection in research
- Understand the audit/inspection process

The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.

Course Programme:
Coffee & Registration
Regulations in the Pharmaceutical Industry:
- The development of Good Clinical Practice
- The Clinical Trials Directive
The Protection of the Subject in Research:
- The role of the Ethics Committee
- The importance of Informed Consent
Essential Documents:
- Standard Operating Procedures
- Trial Master Files
- Centre Files
- ICH Section 8.0
12.30 - 13.30 Lunch
The Role of the Monitor - workshop
Audit & Inspections:
- Quality Issues
- Who are the Inspectors?
- How to prepare for their visit
Quiz:
- Interactive session summarising the topics of the day
 
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
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Key Details
Duration1 day
 
£590
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).