58. The licensing authority may publish guidance on—
(a)the application format and documentation to be submitted in an application for an ethics committee opinion, in particular regarding the information that is given to subjects, and on the appropriate safeguards for the protection of personal data;
(b)the format and contents of a request for authorisation of a clinical trial, as well as the documentation to be submitted to support that request, on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure;
(c)the presentation and content of any proposed substantial amendment to the clinical trial authorisation insofar as it relates to the protocol;
(d)the declaration of the end of the clinical trial;
(e)the collection, verification and presentation of adverse event or adverse reaction reports, together with decoding procedures for unexpected serious adverse reactions;
(f)the content of essential documents forming part of the trial master file;
(g)the elements to be taken into account when evaluating investigational medicinal products for the purpose of regulation 43(2).]
Textual Amendments
F1Regs. 57, 58 inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 23 (as amended by by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 7); 2020 c. 1, Sch. 5 para. 1(1)