Preparing A Clinical Investigation Plan (CIP) For A Medical Device Study

MEDV09 - September 08 2010

Who would benefit?

This course is suitable for all those concerned with writing or reviewing clinical investigation plans. It is appropriate for and is largely aimed at those who are new to protocol production or have held such responsibility for a short time. This is may include, clinical monitors, research nurses from both industry and academia.

Course Objectives

At the end of the course delegates will understand:-

What preparing a CIP involves.
How to prepare a CIP.
The guidelines applicable to preparing CIPs.

Programme

The protocol is a document that descibes the objectives, design, methodology, statistical considerations and organisation of a clinical study and is regarded as an essential document. This practical workshop will take you through the evolution of a protocol from a primitive state to the final comprehensive document. This one day practical course will use real examples to develope a CIP:-

What is a CIP, what is it used for and why is it required?
Guidelines for protocol production, format and structure of the protocol.
Conducting literatures searches, how a protocol should be presented and what it should contain, ethical considerations and administrative procedures.
Key aspects of the protocol, scientific considerations, study design, types of studies, study rationale, safety and efficacy objectives, study population, methods of assessment.
Statistical considerations.

Training course booking form

Microsoft Word .doc - Click here to download
Adobe Acrobat .pdf - Click here to download

The form contains the prices and terms & conditions. Please return the completed form either:

As an attachment e-mailed to enquiries@medvance.co.uk,
By fax: +44 (0)1757 270055
By post to: Medvance Ltd, Medvance House, Burn Grange, Doncaster Road, Burn, Selby, North Yorkshire, YO8 8LA, United Kingdom

(NB: Please note that .pdf can only be printed, and then faxed or posted, and not re-edited. Some users may need to right click on the above links and click 'Save target as...'. In order to open/view PDF documents you will need Adobe Reader software installed which can be obtained free from Adobe's Website (click here))