Transcription of Australian clinical trial handbook
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Australian clinical trial handbook
Australian clinical trial handbook Guidance on conducting clinical trials in Australia using unapproved therapeutic goods Version , August 2021 Therapeutic Goods Administration Australian clinical trial handbook August 2021 Page 2 of 62 Copyright Commonwealth of Australia 2021 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so.
Reports from post-market studies----- 42. Clinical trial phases and stages _____ 43 ... performance and/or safety of the product. It is therefore necessary that clinical trials are ... • medical devices (including in vitro diagnostic medical devices (IVDs) ) • biologicals (including human cell and tissue -based therapeutic goods, or live ...
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