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Drug Safety for Medical Writers Part 2: Laboratory Data

Level:
Foundation
Area:
Drug Development
Code:
DDF23a
Duration:
03:00:00
Workshop profile:
This workshop is intended for medical writers who are new to writing the safety sections of clinical study reports or related safety summaries.
Objective:
This workshop is designed to give medical writers insight into the processes by which laboratory data, vital signs and ECG data are generated and recorded during clinical trials and the subsequent handling of these data. On completion of the workshop package, participants should be confident in their approach to writing the laboratory and other safety data sections of documents relating to clinical trials, particularly clinical study reports.
Content:
The role of the medical writer in preparing summaries of safety data are to take a large amount of information and to present the most important points in a useful and understandable format. The challenge for the writer is to identify what is important and to answer the readers’ questions before they have been asked. The collection of laboratory, vital sign and ECG data on a drug begins at the clinical trial level. All safety summaries are built upon this starting point. The aim of the workshop is to bring the data to life so that the writer can present safety data that are interesting to the reader.