Pharma school ICH GCP Questions with correct answers

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol CORRECT ANSWER c. CTA and Ethics Committee Approval What C is missing from this statement in ICH GCP: The sponsor should provide insurance or should indemnify (legal and financial ____________) the investigator against claims arising from the trial, except for claims arising from malpractice and/or negligence? section 5.8.1 a. Compensation b. Coverage c. Costs d. Compliance CORRECT ANSWER b. Coverage Complete this statement from ICH GCP: neither the investigator, nor the trial staff, should _________ or unduly influence a subject to participate or to continue to participate in a trial. a. Convince b. Coerce c. Compel d. Change the opinion CORRECT ANSWER b. Coerce What does ICH GCP state about how to preserve the independence and value of an audit? section 5.19.3d