Hi all,
Do you have recommendations regarding the preparation of clinical study reports (CSRs) for multiple regions, and mainly regarding the appendices of the reports. Do you produce a single CSR for multiple regions, including all appendices with e.g. for appendix 16.1.5 the signatures of the EU investigators? What about the BRIC regions (Brazil, Russia, India and China), Australia, and Japan? Thanks in advance, Clarisse
-------------------------------------------
Clarisse Stone RAC
Manager, Electronic Documents
Galderma R&D
Cranbury NJ
United States
-------------------------------------------