Hi Elizabeth,
The choice of CTN or CTX scheme, is with the local study sponsor and then with the HREC that reviews the protocol here in Australia. If the HREC has the expertise (technical/scientific) to assess the safety of the study, then CTN would be considered. Most of the studies are conducted under the CTN scheme and if the study has already been reviewed/approved by FDA, CTN would most likely be considered by the sponsor and HREC.
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Silvana Sekuloski PHD, RAC
Clinical Operations Manager
QIMR Berghofer Medical Research Institute
Brisbane
Australia
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Original Message:
Sent: 27-Apr-2017 14:12
From: Elizabeth Ashraf
Subject: CTX versus CTN in Australia
Hi,
I would welcome input about whether a CTN would support a US submission. I don't see why one would use the much longer CTX scheme rather than the CTN. Thanks for your help.
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Elizabeth Ashraf
Madison NJ
United States
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