Regulation 4

an obligation of the sponsor in regulations 6, 8(1), 9(1), 10(3) and (5), 11(1) and (3), 12 and 25(1)(a)(ii) and (b)(ii) and (2)(b) is an obligation of the lead sponsor of the trial; and

an obligation of the sponsor in any other provision of these Regulations is an obligation of each of the sponsors of the trial in relation to the part of the trial for which the sponsor has assumed responsibilities as sponsor (unless the provision specifies otherwise) and a reference to the trial in that provision is to that part of the trial.

the sponsor or, in a clinical trial with more than one sponsor, the lead sponsor, must —

evaluate during the trial on an ongoing basis the safety of the investigational product; and

promptly notify all principal investigators of the trial and, in a clinical trial with more than one sponsor, all other sponsors and all principal investigators of the trial, of —

any information which suggests that the safety of the subjects of the trial could be adversely affected (including of any USADR occurring in any subject of the trial); and

any findings which could impact the conduct of the trial; and

in a clinical trial with more than one sponsor, every sponsor that is not a lead sponsor must —

promptly report to the lead sponsor any serious adverse event which occurs in a subject during the trial, and furnish to the lead sponsor a detailed written report on the event as soon as possible thereafter, other than any serious adverse event specified in the protocol as not requiring immediate reporting;

promptly report to the lead sponsor any information which suggests that the safety of any subject of the trial could be adversely affected;

promptly report to the lead sponsor any findings which could impact the conduct of the trial; and

provide such information to the lead sponsor as may be necessary for the lead sponsor to comply with the obligations of the lead sponsor under these Regulations in relation to the trial.