View source for Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify

{{ReferenceData
|has_document=Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
|module=4
|unit=4.1.4
|scope=HM
|doc_part=D
Who should notify
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00049-Ser-Ver ++ TAG-00017-Spo-die ++ TAG-00148-Con-rsc ++ TAG-00183-Aut-Ver ++ TAG-00111-Agr-chr
|tags_display=[[Glossary:TAG-00049-Ser-Ver|Serious breach]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00148-Con-rsc|CRO]], [[Glossary:TAG-00183-Aut-Ver|Authorised representative]], [[Glossary:TAG-00111-Agr-chr|Written agreement]]
|comment=Notification arrangements for serious breaches
|content=D. Arrangements for notification
Who should notify?
The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a legal representative or contract research organisation (CRO)), if this function has been delegated by the Sponsor to another party. In accordance with Statutory Instrument 2004/1031 as amended by Statutory Instrument 2006/1928, the Sponsor retains legal responsibility even if the function is delegated (Regulation 3.12). The CRO is also legally responsible for compliance with the legislation in relation to functions delegated by the Sponsor to the CRO (Regulation 3.8). However, in the interests of subject safety, reporting should not be delayed by discussion over reporting responsibility.
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}}