Forlíontar an creat reachtach sin leis na rialacha i dTreoir 2001/20/CE lena leagtar síos caighdeáin shonracha maidir le cosaint daoine is ábhar do thrialacha cliniciúla.
That legislative framework is supplemented by the rules in Directive 2001/20/EC laying down specific standards for the protection of clinical trial subjects.
tuairisc ar na socruithe chun cloí leis na rialacha is infheidhme maidir le bailiú, stóráil agus úsáid todhchaí samplaí bitheolaíochta ó dhaoine is ábhar do thrialacha cliniciúla, i gcás inarb infheidhme, mura rud é go mbeidh siad i ndoiciméad ar leithligh;
a description of the arrangements to comply with the applicable rules for the collection, storage and future use of biological samples from clinical trial subjects, where applicable, unless contained in a separate document;
Is é an cuspóir atá leis an údarú cearta, sábháilteacht agus folláine na ndaoine is ábhar do thrialacha cliniciúla a chosaint, agus iontaofacht agus stóinseacht na sonraí arna nginiúint leis an triail chliniciúil a áirithiú.
The purpose of the authorisation is to protect the rights, safety and well-being of clinical trial subjects and to ensure the reliability and robustness of the data generated by the clinical trial.
Is gá oibríochtaí iolracha a dhéanamh de bharr trialacha cliniciúla, lena n‐áirítear na táirgí íocshláinte imscrúdaitheacha a mhonarú, a iompar agus a stóráil, iad a phacáistiú agus a lipéadú, agus na táirgí sin a thabhairt do na daoine is ábhar do thrialacha cliniciúla agus faireachán a dhéanamh ar na daoine is ábhar ina dhiaidh sin, agus dramhaíl agus táirgí íocshláinte imscrúdaitheacha nár úsáideadh a dhiúscairt.
Clinical trials necessitate the performance of multiple operations, including the manufacture, transport and storage of the investigational medicinal products, packaging and labelling, the administration thereof to clinical trial subjects and subsequent monitoring of the subjects, and the disposal of waste and unused investigational medicinal products.