Regulation 30 Fees for inspections relating to good clinical practice in clinical trials

Unless regulation 44 applies a fee in accordance with paragraphs 2 and 3 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—

(a)

is—

(i)

conducting, or has conducted, a clinical trial, or

(ii)

performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),

in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or

(b)

has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.