Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsWithout limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:
(a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and
(b) the name of, and the contact details for, the principal investigator for each trial; and
(c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and
(d) information about whether or not any conditions specified by
the committee have been met.