Section 16: Suspension or cancellation of trial licence

16. Suspension or cancellation of trial licence (1) Subject to subsection (2), the Council may, after giving the sponsor and the investigator written notice of its intention and allowing them not less than 14 days to make representations to the Council, suspend or cancel a trial licence and order the suspension or the termination of a clinical trial where— (a) the clinical trial has not started within 12 months of the date on which the trial licence was issued; (b) the clinical trial has started and has been suspended for more than 6 months; (c) the sponsor or the investigator has, in connection with the clinical trial, trial licence or application for the licence, given false or misleading information; (d) the clinical trial is not being conducted in accordance with this Act or any condition imposed under section 13; or (e) there has been such change in the scientific reasons or circumstances that the clinical trial is no longer justified. (2) (a) The Council may, where it is satisfied that the health, welfare, safety or protection of a subject is being or is likely to be compromised, forthwith suspend a trial licence and order the suspension of a clinical trial. (b) The Council shall, where it has made an order under paragraph (a)— (i) forthwith give written notice of its decision to the sponsor and the investigator; (ii) invite them to make representations on the matter within 7 days; and C25A – 13 [Issue 4] Clinical Trials Act (iii) not later than 14 days after the receipt of any representations or, if no representations have been received, within 14 days of the issue of the notice under subparagraph (i), determine whether or not the trial licence shall be cancelled and the clinical trial terminated. (3) The Council shall cause to be published in the Gazette and on the website of the Ministry such particulars as it thinks fit of any trial licence which is suspended or cancelled. (4) Where a clinical trial is discontinued under section 25 (2), or is suspended or terminated under this section, its sponsor shall incur the cost of— (a) any treatment which a subject of the clinical trial may require; (b) any insurance cover to be contracted for the subject. PART VI – CONDUCT OF CLINICAL TRIALS (Part VI came into operation on 24 September 2011.)