GCP Fundamentals Quiz Quiz

1. Investigator Qualifications

   According to GCP, the investigator should be qualified by what?

   1. Expertise, training and experience
   2. Education, training and experience
   3. Training and experience
   4. Education and training
   5. Education, experties and training

2. Sponsor Responsibilities

   Which of the following is included in the sponsor responsibilities?

   1. Design study
   2. Finance study
   3. Audit study
   4. All of the above
   5. None of the above

3. Clinical Trial Conduct

   Who is the person responsible for the conduct of the clinical trial at a trial site according to GCP?

   1. Clinical research coordinator
   2. Monitor
   3. Investigator
   4. Sponsor
   5. Data Entry Clerk

4. Data Handling and Verification

   According to GCP, how should data from a clinical trial be handled and verified?

   1. Qualified data managers
   2. Appropriately qualified individuals
   3. Adequately trained individuals
   4. GCP does state any requirement
   5. Volunteers

5. GCP Principles

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

   1. Data accuracy
   2. Protection of trial subjects
   3. Process adherence
   4. Statistical quality checks
   5. Cost effectiveness

6. Ethics Committee Requirements

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

   1. They should have SOPs
   2. They should have one member who is independent of the trial site
   3. Their members should not be paid
   4. They should make decisions about approvals only at meetings
   5. They must hold regular meetings

7. Terms in GCP

   Which of the following words does not appear in GCP documentation?

   1. Placebo
   2. Medicine
   3. Medical
   4. Treatment
   5. Health

8. Sponsor Action for Non-Compliance

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

   1. Prompt action to secure compliance
   2. Immediate report to the regulatory authority
   3. Legal action against the site
   4. For cause audit
   5. Ignore the problem

9. CRO Definition

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

   1. Commercial
   2. Clinical
   3. Contact
   4. Contract
   5. Cooperative

10. Patient Information Sheet Responsibility

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

    1. The sponsor
    2. The investigator
    3. The Ethics Committee
    4. The auditor
    5. The regulatory authority

11. Audits

    According to ICH GCP, what is the purpose of an audit?

    1. To ensure the trial is profitable
    2. To ensure the quality of the data
    3. To ensure compliance with GCP and regulations
    4. Both B and C
    5. None of the above

12. Essential Documents

    According to GCP, what are essential documents?

    1. Documents which individually and collectively permit evaluation of the conduct of a study
    2. Documents that only the sponsor need to keep
    3. Documents to ensure regulatory compliance
    4. Documents that are easily accessable for the auditor
    5. Both C and D

13. Informed Consent

    What is the primary purpose of the informed consent process in clinical trials according to GCP?

    1. To obtain participants' signatures on a legal document
    2. To ensure participants understand the trial risks and benefits and voluntarily agree to participate
    3. To protect the investigator from legal liability
    4. To ensure that the study meets its enrollment targets
    5. To save time

14. Investigator's Brochure

    According to ICH GCP, what is the purpose of the Investigator's Brochure?

    1. A document for patients to understand the clinical trial
    2. A compilation of the clinical and non-clinical data on the investigational product
    3. A document containing the study protocol
    4. A brochure listing the investigators involved in the study
    5. A document for data management

15. Adverse Events

    According to GCP guidelines, what action should be taken when a serious adverse event occurs during a clinical trial?

    1. Ignore the event if it is not related to the study drug
    2. Report the event only if it is life-threatening
    3. Report the event immediately to the appropriate regulatory authority, ethics committee and sponsor
    4. Wait until the end of the trial to report all adverse events
    5. Report to the PI first