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A serious adverse event (SAE) is defined in the Regulations as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation, that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or...
Licence holders are required to notify NHSBT of serious adverse events (SAEs) or serious adverse reactions (SARs) within 24 hours of discovery. Establishments should take note that a full investigation of an event or reaction is not required for the purposes of initial reporting.
The HTA was asked to provide information on how many, if any, cases of imported human body tissue for use in medical research or medicines have been successfully imported from the People’s Republic of China to the UK since 2010.
The HTA was asked to provide information on its intranet and IT services.
The HTA commissioned Savanta ComRes to run a professional evaluation in early 2020.
These reports provide valuable insight into:
Staff at HTA-licensed establishments should refer to the Governance and Quality Systems section of the HTA’s Code of Practice B on Post-mortem Examination.
All information relating to donor and organ characterisation must be kept for a period of 30 years from the date of retrieval of the organ.