Paragraph 1 InterpretationF1

In this Schedule—

• “end of trial date” is the date of the conclusion of the trial that is specified in the protocol of a clinical trial and which, in the case of a clinical trial conducted in other countries as well as the United Kingdom, is the end of the date of the trial in all the participating countries;

• “the new rules” means these Regulations as in force on and after the relevant day;

• “new rules clinical trial” means a clinical trial which is not an old rules clinical trial;

• “old committee” means an ethics committee recognised under the old rules that has been abolished or has ceased to operate as an ethics committee for the purposes of these Regulations;

• “the old rules” means these Regulations as in force immediately before the relevant day;

• “old rules clinical trial” is to be construed in accordance with paragraph 2(1)(a);

• “the relevant day” means the day on which this Schedule comes into force.

Where, by virtue of this Schedule, the old rules continue to apply, regulation 2 of the old rules applies to the interpretation of the old rules, except in so far as it is necessary for regulation 2 of the new rules to apply to their interpretation in order to give effect to a provision of this Schedule (for example, because a new committee is performing functions of an old committee).

For purposes of this Schedule, “sponsor”, in the context of the old rules, has the meaning given in regulation 3 of the old rules.

Regulation 53 of the new rules applies to both the new rules and the old rules.