Regulation 31 Suspension or termination of clinical trial

the licensing authority have objective grounds for considering that—

is no longer satisfied (either generally or at a particular trial F4location);

the licensing authority have information raising doubts about the safety or scientific validity of the trial, or the conduct of the trial at a particular trial F5location; or

the trial has lapsed in accordance with regulation 26 and the sponsor has not notified the licensing authority that the trial has ended,

in a case where the suspension or termination applies to the trial generally, on—

in a case where the suspension or termination applies to the conduct of a trial at a particular trial location, on—

whether the notice applies to the trial generally or to one or more of the trial F8locations;

whether the notice requires suspension or termination of the trial F9in whole or in part, and, if it applies to part of the trial, to which part it applies;

if the notice requires suspension of the trial—

whether suspension or termination is to take effect immediately on receipt of the notice or on such date as may be specified in the notice.

where the notice has not been served on the sponsor, the sponsor;

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the relevant ethics committee;

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inform him that the authority is minded to issue a notice suspending or terminating the trial F14(in whole or in part), or the conduct of a trial at a particular F15location, and of the reasons why they are so minded; and

advise him that they may, within one week of the date of the notice, furnish the authority with written representations as to whether the trial, or the conduct of the trial at a particular location, should be so suspended or terminated.