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The Clinical Study Protocol: Content and Structure

Level:
Foundation
Area:
Drug development
Code:
DDF12
Duration:
03:30:00
Workshop profile:
The workshop is intended for medical writers with little or no experience of writing clinical study protocols (CSPs), although basic knowledge of the clinical development process is expected.
Objective:
The objective of this workshop is to introduce participants to the elements of the CSP. The emphasis will be on the formal content and structure of the CSP document; aspects of the process of CSP preparation, as well as indication-specific content, will only be marginally mentioned. On completion of the workshop, participants should feel more confident in accepting responsibility for the development of a CSP; in line with this, they should feel encouraged to work towards medical writing involvement in CSP preparation.
Content:
The idea of this workshop is based on the following scenario: a sound and approved CSP outline is given to a medical writer who is charged with the preparation of the complete CSP document including all attachments. Assuming maximum freedom, what should a good CSP document look like? Which type of information should be included, and how should it be grouped? To this end, the workshop will include a discussion of the principles that should drive the selection of CSP content elements, followed by a proposed detailed structure of a CSP document.