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Information on clinical trials and reports.
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11.—(1) Every person who conducts a clinical trial shall—
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(a) in respect of any place under his control which the Minister reasonably believes is being or has been used in connection with the trial, permit any person, duly authorised by the Minister, to inspect such place for the purpose of determining whether or not the permission to undertake the trial is being or was complied with,
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(b) comply with any request for information in relation to the progress of the trial which the Minister or any person duly authorised by him may from time to time request, and
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(c) upon becoming aware of or suspecting any adverse reaction affecting a participant as a consequence of the trial being conducted, forthwith report that fact to the Minister.
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(2) Every person, other than the person conducting the trial, who administers a substance or preparation for the purpose of a clinical trial shall, upon becoming aware of or suspecting any adverse reaction as a consequence of the substance or preparation being administered, forthwith report that fact to the person conducting the trial.
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