GCP Quiz 1

According to GCP the investigator "should be qualified by..."

• Expertise, training and experience

• Education, training and experience

• Training and experience

• Education and training

Sponsor responsibilities include

• Design study

• Finance study

• Audit study

• All of the above

The person responsible for the conduct of the clinical trial at a trial site.

• Clinical research coordinator

• Monitor

• Investigator

• Sponsor

How does GCP define who should handle and verify the data from a clinical trial?

• Qualified data managers

• Appropriately qualified individuals

• Adequately trained individuals

• GCP does state any requirement

According to the principles of GCP, what is the most important consideration when conducting a clinical trial?

• Data accuracy

• Protection of trial subjects

• Process adherence

• Statistical quality checks

Which of the following is NOT a requirement for Ethics Committees under GCP?

• They should have SOPs

• They should have one member who is independent of the trial site

• Their members should not be paid

• They should make decisions about approvals only at meetings

Which of the following words does not appear in GCP?

• Placebo

• Medicine

• Medical

• Treatment

According to ICH GCP what action should the sponsor take in the event of non-compliance by investigational site staff?

• Prompt action to secure compliance

• Immediate report to the regulatory authority

• Legal action against the site

• For cause audit

According to ICH GCP what does the C in CRO stand for?

• Commercial

• Clinical

• Contact

• Contract

According to GCP who is responsible for the content of the Patient Information Sheet?

• The sponsor

• The investigator

• The Ethics Committee

• The auditor