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Medical Writing for Non-interventional and Database Studies

Level:
Advanced
Area:
Drug Development
Code:
DDA29
Duration:
03:30:00
Workshop profile:
This workshop addresses writers dealing with or interested in documents for non-interventional (observational) studies for epidemiology, real life safety and efficacy, health economics, and quality of life. This is a development of the DDA 9 workshop with an emphasis on the new opportunities to design studies using existing clinical databases. Participants should have at least 2 years of medical writing experience with study related documents (e.g. protocol, CSR, scientific publication).
Objective:
This workshop provides you with the definition of non-interventional studies, how they differ from randomized controlled clinical trials (RCT) and what is the regulatory background for these differences. The diversity of types of non-interventional studies will be explained, with special emphasis on recent study designs using existing clinical databases instead of study specific databases. It will be explained how documents for non-interventional studies are prepared by medical writers (in particular protocols and study reports), in particular how writing will differ from RCTs.
Content:
What is non-interventional research. Definition of non-interventional studies. Scientific Goals of Non-Interventional Studies. Different Designs of Non-interventional Studies. Use of Databases in Non-interventional Studies. Are Non-Interventional Studies Scientifically Valid? Documents for Non-interventional Studies, similarities and differences to RCT documents (SAP, Protocols, ICF, Reports, Publications, Transparency Reporting). Specific ways to describe Non-interventional Study design and study results. Differences in discussion and interpretation of the data compared to RCTs.