Clinical trial controls - Clinical trial approval

Question 1

What is non-clinical testing

Answer 1

Involves testing of the investigational products in laboratory experiments or on animals

Question 2

Does non-clinical testing require regulatory approval

Answer 2

No

Question 3

What is clinical testing

Answer 3

Investigational products are administered to human subjects in the context of a clinical research study to verify the products’ safety and efficacy.

Question 4

Approvals required for clinical trials in human subjects

Answer 4

1. Regulatory approval by HSA,
2. Ethics approval by the relevant Institutional Review Board, or IRB.

Question 5

basic legal requirements for clinical research studies

Answer 5

1. Ethics approval from an IRB;
2. Informed consent obtained from the subject or a legal representative; and
3. The reporting of serious adverse events that arise during the study.

Question 6

_______ of the Human Biomedical Research Act lists the types of clinical research studies that are excluded from the ambit of the Act

Answer 6

Second Schedule

Question 7

Types of clinical research studies that are excluded from the Human Biomedical Research Act

Answer 7

1. Clinical trials of health products conducted in accordance with HPA 2007
2. Clinical trials of medicinal products conducted in accordance with Medicines Act 1975

Question 8

Which products’ clinical trials do Human Biomedical Research Act apply to

Answer 8

Class 1 CTGTP, medical devices

Question 9

Which products’ clinical trials do Health Products (Clinical Trials) Regs apply to

Answer 9

TP, Class 2 CTGTP

Question 10

Which products’ clinical trials do Medicines (Clinical Trials) Regs apply to

Answer 10

Medicinal products e.g., CPM

Question 11

Class 2 CTGTP vs Class 1 CTGTP: which is higher risk?

Answer 11

Class 2

Question 12

Clinical research materials are exempted from _____ requirements

Answer 12

1. Dealer licensing (for manufacture, import and supply)
2. product registration