Good Clinical Practice (GCP) Training and Finding

According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often?

A. at least once a year

B. at intervals appropriate to the degree of risk to human subjects, but at least once per year

C. at intervals appropriate to the degree of risk to human subjects, but at least once during the accrual period of the trial

D. there is no guidance provided

According to ICH GCP, who may be asked the IRB/IEC to provide its written procedures and membership lists?

A. Investigator

B. Sponsor

C. Regulatory Authority

D. All of them

According to ICH GCP an IRB/IEC should safeguard the:

A. Rights and well-being of all trial subjects

B. Rights and safety of all trial subjects

C. Safety and well-being of all trial subjects

D. Rights, safety, and well-being of all trial subjects

GCP Training