View source for Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A

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{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| HM
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! Document part
| Article 29A
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Sponsor obligation to notify licensing authority of serious breaches
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== Content ==
29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of -
(a) the conditions and principles of GCP in connection with that trial; or
(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach.
(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree –
(a) the safety or physical or mental integrity of the subjects of the trial; or
(b) the scientific value of the trial