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Welcome to your Test your knowedge of Good Clinical Practice (GCP)

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1. What is the most important consideration during a clinical trial ?
2. Who is responsible for trial conduct at the site ?
3. What does ICH GCP defines as: “A document describing the objective(s), design, methodology, statistical considerations, & organization of a trial.”
4. Prior to starting a clinical trial, the protocol must be approved by the:
5. What must be obtained from all potential trial subjects before they take part in the trial ?
6. What is the minimal frequency for continuing review conduct by the Institutional Review Board / Independent Ethics Committee (IRB/IEC) regardless of the degree of risk to human subjects ?
7. What is the minimum number of members on an IRB/IEC ?
8. There must be at least one IRB/IEC member with the following characteristic:
9. How long must the IRB/IEC maintain their records securely ?
10. What is the general purpose of the Investigator’s Brochure ?
11. What word is missing about Informed Consent: “Neither the investigator, nor the trial staff, should ______________ or unduly influence a subject to participate or to continue to participate in a trial.”
12. What does GCP say about CRF corrections: “Any change or correction to a CRF should be dated, initialled, and explained (if necessary) and should not _________________”
13. What WORD IS MISSING? “All serious adverse events (SAEs) should be reported immediately to the sponsor except for _______________”
14. The investigator must conduct the trial in compliance with 3 requirements. Which is not one of them ?
15. Which of the following is not one of the 3 main goals of clinical trial monitoring ?
16. What does GCP say about the required extent of monitoring activities ?
17. What essential document does the following refer to ? “________ is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures.”
18. What is described in the following GCP definition: “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”
19. What is described by the following GCP definition: “An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial”.
20. What does ICH GCP describe as: “The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.”
21. What documents the existence of the subject and substantiates integrity of trial data collected ?
22. What document, created in 1964, provides the foundation for ethical considerations in clinical research ?
23. Which of the following statements best describes an Adverse Event ?
24. What term describes “Documentation that allows reconstruction of the course of events.”
25. What is a term for “An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.”