Assertion: imp | /r/HasProperty | shipped to clinical sites
Facets:
value: prior
type: TEMPORAL
Source sentences:
text: Whilst there is no specific requirement preventing IMP being shipped to clinical sites prior to step two of the process, there would need to be appropriate, robust controls in place to prevent supply to the clinical trial investigator for administration to trial participants before the licensing authority has approved the clinical trial and a favourable opinion has also been received by an ethics committee (Article 9 of Directive 2001/20/EC and regulations 12 and 13 of SI 2004/1031 in the UK).