Question

Who else will need to approve before the subject may go on trial if a subject does not meet Inclusion/Exclusion criteria but is approved by the sponsor?

1) Ethics committee
2) Regulatory authority
3) Data monitoring committee
4) Principal investigator

Answer 1

If a subject does not meet the Inclusion/Exclusion criteria but is approved by the sponsor, it needs approval from the regulatory authority, ethics committee, and principal investigator before going on trial.

Step-by-step explanation:

If a subject does not meet the Inclusion/Exclusion criteria but is approved by the sponsor, it still needs to be approved by several other parties before it can go on trial:

1. Regulatory Authority: The regulatory authority is responsible for ensuring that the trial meets ethical, legal, and safety standards.
2. Ethics Committee: The ethics committee reviews the trial protocol to ensure that it respects the rights and welfare of the research subjects.
3. Principal Investigator: The principal investigator is the individual responsible for conducting the trial and is typically affiliated with the research institution.