Regulation 8
Application for clinical trial certificates
of Medicines (Clinical Trials) Regulations 2016
Subregulation 1
The sponsor must apply to the Authority for a clinical trial certificate for each principal investigator of the clinical trial, before the commencement of the trial.
Subregulation 2
The application for any clinical trial certificate must be made in the form and manner specified on the Authority’s website.
Subregulation 3
Where the application is for a clinical trial certificate for a clinical trial in an emergency situation, the Authority must not issue any clinical trial certificate for the trial unless a principal investigator who is conducting the trial and 2 specialists who are not conducting the trial certify in writing that —
the trial needs to be conducted on potential subjects who are facing a life-threatening situation to determine the safety or efficacy of a medicinal product;
available treatments or procedures are unproven or unsatisfactory;
there is a reasonable prospect that participation in the trial will directly benefit the potential subjects because —
the potential subjects are facing a life-threatening situation that necessitates intervention;
the appropriate non-clinical and clinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the proposed use of the medicinal product to provide a direct benefit to the potential subjects; and
the risks associated with the trial are reasonable in relation to what is known about —
the medical condition of the potential subjects;
the risks and benefits of standard therapy, if any; and
the risks and benefits of the proposed use of the medicinal product;
the potential subjects are unable to consent to being subjects as a result of their medical condition;
it is not feasible to obtain consent from the legal representatives of the potential subjects within the window period;
there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the trial; and
the trial cannot practicably be carried out if the consents referred to in regulation 16 must be obtained.