PART 11Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
Meaning of “good clinical practice accreditation scheme”35
In this Part—
“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and
“Phase 1 trials” are clinical trials to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
Fees for applications for membership and certificates36
1
The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £126.
2
The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £67.