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From Protocol to Study Report: What’s In-between?

Level:
Foundation
Area:
Drug Development
Code:
DDF6b
Duration:
03:00:00
Workshop profile:
This workshop is designed for medical writers who are new in the field of regulatory writing and clinical development. The workshop will provide an overview of the conduct of a clinical trial. Although the workshop does not go into detail about each of the topics addressed, it will serve as a basis for more specialised workshops.
Objective:
After the workshop the participants should have an understanding of how a clinical study is conducted and how individual patient data collected at an investigational site are converted into the study results. This workshop aims to provide an overview of the different steps of a clinical trial (clinical phase, data management, statistical analysis) with an emphasis on the handling of patient data. Based on this overview a medical writer should be able to improve the description of study conduct and study results in an integrated study report.
Content:
Based on pre-workshop reading of the most relevant ICH guidelines, the different steps of a clinical trial will be discussed. This will include the clinical phase (basic regulatory requirements, monitoring), data management (data entry, data cleaning, coding, electronic data capture) and statistics (analysis plan, steps of analysis). The flow of data from the investigational site to the study report will be summarised. Participants will identify relevant information needed for the preparation of a study report.