Section 18: The sponsor
consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.
18. The sponsor
(1) Subject to the approval of the Council, a sponsor and an investigator
may be the same person.
(2) Every sponsor shall comply with the terms and conditions of any trial
licence issued to him.
(3) Every sponsor shall designate an investigator who shall be based in
Mauritius and be responsible for the conduct of the trial within Mauritius.
(4) Every sponsor shall be responsible for implementing and maintaining
quality assurance and quality control systems with written standard operating procedures.
(5) A sponsor of a clinical trial shall notify the Council in writing of any
serious breach of—
(a) the conditions and principles of good clinical practice in connection with that trial; or
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Revised Laws of Mauritius
(b) the trial licence issued by the Council.
(6) For the purpose of this section, “serious breach” means a breach
which is likely to affect to a significant degree—
(a) the safety or physical or mental integrity of a subject; or
(b) the scientific value of a clinical trial.