Singapore legislation
Regulation 5
Regulation 5
Principal investigator, etc.
Subregulation 1
The sponsor must ensure that the clinical trial is conducted by or under the supervision of a principal investigator who —
is a qualified practitioner or qualified pharmacist; and
is qualified by education, training and experience, and has adequate resources, to properly conduct the trial.
Subregulation 2
A principal investigator must declare to the institutional review board whose approval for the clinical trial is being sought, every direct and indirect financial interest which the principal investigator, and any person assisting the principal investigator in the trial, has in the trial.
Subregulation 3
A principal investigator must ensure that —
the medical care given to a subject in the clinical trial, and all medical decisions relating to the trial made on behalf of the subject, are the responsibility of at least one investigator who is a qualified practitioner referred to in paragraph (a) of the definition of “qualified practitioner” in regulation 2(1); and
the dental care given to a subject in the trial, and all dental decisions relating to the trial made on behalf of the subject, are the responsibility of at least one investigator who is a qualified practitioner referred to in paragraph (b) of the definition of “qualified practitioner” in regulation 2(1).
Subregulation 4
Only the following persons in a clinical trial may treat, or administer any investigational product of the trial to, a subject of the trial:
an investigator who is a qualified practitioner;
a person who is assisting, and acting under the instructions of, such investigator.
Subregulation 5
Despite paragraph (4), in an emergency, any qualified practitioner may treat a subject if it is in the interest of the subject.
Subregulation 6
A principal investigator and any person assisting the principal investigator must conduct the clinical trial in accordance with these Regulations.