Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

• A.China
• B.Switzerland
• C.Brazil
• D.India

Comment: *

Name: *

Email: *

Verification: *

An approved investigational device exemption (IDE) permits a device to be:

• A.Shipped lawfully for the purpose of conducting a clinical study
• B.Sold and marketed for profit
• C.Used on a patient who is not enrolled on a clinical study
• D.Marketed as a humanitarian device

Comment: *

Name: *

Email: *

Verification: *

According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

• A.OHRP
• B.Investigator/institution
• C.Regulatory authority
• D.DSMB

Comment: *

Name: *

Email: *

Verification: *

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

• A.Execute material transfer agreement
• B.Ship under dangerous goods requirements
• C.Obtain IRB/IEC approval for revised protocol and ICF
• D.Notify enrolled subjects

Comment: *

Name: *

Email: *

Verification: *

While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?

• A.A subject's signature is missing on the copy of the summary of the short form consent
• B.A copy of the consent document was not provided to a subject
• C.Only the signatures of the person obtaining consent and the witness appear on the copy of the summary of the short form consent
• D.The sponsor-generated informed consent template is missing required elements

Comment: *

Name: *

Email: *

Verification: *