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Medical Writing for Healthy Volunteer Studies

Level:
Advanced
Area:
Drug Development
Code:
DDA18a
Duration:
03:30:00
Workshop profile:
This workshop is for medical writers who would like to learn more about writing the documents needed for clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies). Participants should have basic knowledge of healthy volunteer study objectives and design (participants who do not have this knowledge should first take Workshop DDF39 An Overview of Healthy Volunteer Studies) and some experience in writing key clinical trial documents (informed consent forms, protocols, clinical study reports).
Objective:
Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers need to understand how these studies differ from clinical trials in patients and how the differences affect the documents required for these studies. After attending this workshop, the participant will understand the unique structural and content requirements of documents related to healthy volunteer studies.
Content:
This workshop will cover the following topics for healthy volunteer studies: • Key regulatory guidance documents • Protocols • Informed consent forms • Clinical study reports Note: Phase I studies in patients will not be covered. Note: This workshop has been revised to give more time to focus on writing the documents needed for clinical trials conducted with healthy volunteers.