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Medical Writing and Quality Control: Clinical Study Reports

Level:
Foundation
Area:
Professional Techniques
Code:
PTF4
Duration:
03:00:00
Workshop profile:
The workshop is aimed towards medical writers at all levels of experience, and whether working in a freelance capacity, or within a CRO environment, or for a pharmaceutical company. It will be an ideal forum for those who either have no quality control (QC) system in place, or are looking to develop one, whilst those with experience of working with, or implementing QC systems will be able to explore and share best practice. It is not necessary to have attended any other workshops.
Objective:
For a medical writer the correct application of a QC process minimises errors in the factual presentation of data, rectifies spelling mistakes and ensures accurate document structure. At the end of the workshop, participants should have an understanding of why it is important to have a QC procedure in place for written documents including clinical study reports, when in the writing process QC should be implemented, and how to document the results.
Content:
The importance of QC in medical writing will be covered. The consequences of not implementing and following a QC process will be discussed. QC requirements, who should perform the task, and how to carry it out will all be addressed. The workshop is designed to both inform and share experiences; therefore interaction of participants will be actively encouraged. Although the workshop is applicable to other types of medical writing it will primarily use clinical study reports as working examples.