How to Write a Protocol for a Clinical Study
Categories: Pharmaceutical
What Is The Course About?
This course is intended for people who have to write clinical protocols, whether they be medical writers or other clinical research personnel. The course will provide a detailed breakdown of how to get started when writing a protocol, the advantages and disadvantages
of different study designs and what should be included in each section of the main body of the
protocol. The course will be informal and interactive and by the end of the day the delegates will have a better understanding of the need to write a ‘good’ protocol.

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

Course Programme: 
 Introduction
Getting Started
- regulations, guidelines, sources of information, teamwork
Basics Of Study Design
- Building up a picture of the study (study schedule and flow diagram)
- Advantages and disadvantages of different study designs
The Study Summary
- Putting together the skeleton for the study
The Body Of The Protocol
- Giving clear instructions so that the study will be conducted as intended
- Filling in the details
- The ‘standard’ sections
Appendices
- What should be appended
Protocol Amendments
- When, why & how?
Review Of The Day
 
Course Dates
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
Tools
 
Key Details
Duration1 day
 
£590
per delegate