International - Clinical Investigation

Question 1

True or False the FDA requires Approval for all classes of devices.

Answer 1

False. The FDA required an Investigation device exception (IDE) for significant risk devices only.

Question 2

Name the two different pathways for Clinical investigation in Australia.

Answer 2

CTN – Clinical trial notification
No review by TGA
Documents submitted to HREC(Human research ethics committee) - Form and fee and good to go

CTX – clinical trial Exemption - Higher risk devices
Review by TGA for product safety
HREC will review for scientific/ethical issues

Question 3

True or False, Only High risk devices require approval for clinical trials in Canada

Answer 3

False.

Canada requires an ITA - Investigation Testing Authorization for all Class II, III, and IV devices.

Question 4

Generally speaking, all international Clinical Investigations must be carried out under what agreement?

Answer 4

The Helsinki Deceleration.

Question 5

Are there any Standards that can be reverenced for Clinical Investigations?
A)No, reference the regulations only.
B)Yes, there is an ISO standard.
C)No, only a handful of guidance documents

Answer 5

Answer B, yes there is:
ISO 14155:2011
Clinical Investigation of medical devices for human subjects - good clinical practices.

Question 6

Which of the following are important aspects of performing a clinical investigation?
A)Protect participants rights, safety and health
B)Ensure scientific conduct
C)Result credibility
D)Define sponsor(manufacturer) and Principal investigators and responsibilities
E)All of the above

Answer 6

E) All of the Above

All of the above items are important regardless of the country the clinical trial is being performed in.