Document ID: chunk:federal_register_of_legislation:C2022A00026:clause:1_28s:p1
Version: federal_register_of_legislation:C2022A00026
Segment Type: clause
Provision Reference: sch 1 cl 28S (pt 1/2)
Character Range: 52527–55245

28S  Clinical trial licences and clinical practice licences—requirement for ongoing monitoring protocols and to notify adverse events
 (1) A person who is or was the holder of a clinical trial licence must have in place, and comply with, protocols for:
 (a) monitoring the pregnancy of trial participants who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and
 (b) monitoring the ongoing health and development of children born as a result of such pregnancies; and
 (c) seeking the ongoing engagement of trial participants referred to in paragraph (a), and children referred to in paragraph (b), in relation to such monitoring; and
 (d) notifying in accordance with subsection (3) adverse events, for those participants or children, that the person becomes aware of as a result of monitoring referred to in paragraph (a) or (b) of this subsection.
 (2) A person who is or was the holder of a clinical practice licence must have in place, and comply with, protocols for:
 (a) monitoring the pregnancy of patients who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and
 (b) notifying in accordance with subsection (3) adverse events, for those patients, that the person becomes aware of as a result of monitoring referred to in paragraph (a) of this subsection.
 (3) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware of an adverse event for a trial participant referred to in paragraph (1)(a), a child referred to in paragraph (1)(b) or a patient referred to in paragraph (2)(a), the person must notify the adverse event to:
 (a) the NHMRC Licensing Committee; and
 (b) the Secretary; and
 (c) such other persons as are prescribed by the regulations for the purposes of this paragraph;
within the period, in a form and manner, and in accordance with any other requirements, specified in the regulations.
 (4) Without limiting subsection (3), the regulations may require a notification to be in the form approved by the CEO of the NHMRC and to contain any information required by the form.
 (5) A person who is or was the holder of a clinical trial licence or a clinical practice licence must not include in a notification for the purposes of subsection (3) the name, or any other information that could be used to discover the identity, of:
 (a) a trial participant or patient; or
 (b) a child of a trial participant or patient.
 (6) Despite subsections (1), (3) and (5), in the case of a clinical trial licence a person is not subject to a requirement under any of those subsections unless the