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Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to improve and strengthen UK clinical trials legislation.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How and when to submit research applications to ARSAC Guide to submitting research applications to the Administration of Radioactive Substances Advisory Committee (ARSAC). From: Contents ARSAC) research approval for all your research projects where the protocol: requires the administration of radioactive substances specifies the frequency, activity or processing for an administration that would otherwise be considered standard care You do not need to obtain ARSAC research approval for research projects where: the protocol does not specify any administrations of radioactive substanc...