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Protocol Amendments

Level:
Foundation
Area:
Drug Development
Code:
DDF29
Duration:
03:00:00
Workshop profile:
The workshop is intended for medical writers with little or no experience of writing protocol amendments, although basic knowledge of the clinical development process is expected. Moreover, it is recommended that participants had already taken Workshop DDF12 (Content and structure of clinical study protocols; version 2014) although this is not a must. Note: Until 2013 inclusive, the topic of protocol amendments had been part of Workshop DDF12. Therefore, anyone having taken DDF12 in 2013 or earlier is unlikely to fully benefit from Workshop DDF29.
Objective:
On completion of the workshop, participants should feel more confident in accepting medical-writing responsibility for the development of a CSP amendment; they should also feel encouraged to work towards thorough medical writing involvement in the preparation of CSP amendments.
Content:
The workshop will give an overview of what protocol amendments are and how to write them. Content and form of different amendment options (stand-alone amendment versus amended “integrated” CSP)he will be introduced. Key aspects of the process of amendment development will also be covered (Under which circumstances is a CSP amendment needed? How to develop the CSP amendment).