< Back
EMWA Logo EMWA Logo

GCP Training for Medical Writers

Level:
Foundation
Area:
Drug Development
Code:
DDF20
Duration:
03:00:00
Workshop profile:
This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.
Objective:
An understanding of the principles of GCP and how they can be applied in the writing and reviewing of clinical research documents e.g. informed consent forms, clinical study protocols, and regulatory documents e.g. clinical study reports, clinical overviews and summaries.
Content:
The first part of the workshop will provide an overview of the principles of GCP, including the Declaration of Helsinki, the ICH E6 GCP Guideline and the Clinical Trial Directive 2001/20/EC and its amendments. The second part of the workshop will focus on how to ensure that documents are GCP-compliant, and the cross-checks that can be made, particularly when writing clinical study reports.