GCP Training Quiz For Clinical Research Professionals
1. The primary purpose of ______________ is to standardize study conduct and requirements among countries so that studies do not have to be repeated in individual countries.
A. Good Clinical Practice
B. ICH Guidelines
C. Declaration of Helsinki
D. Belmont report
2. During the drug development process, only 1 in 25 compounds was studied to make it into preclinical testing.
3. The main purpose of an IRB is to ensure that the data submitted to the FDA is accurate.
4. When an SMO is involved in the conduct of a study, they become ultimately responsible for how the study is conducted, removing this burden from the investigator.
5. You have been offered a study where the entire trial is to enroll 4000 subjects and to test the effectiveness of a new drug. This is most likely a phase _____ trial.
6. The purpose of a phase III trial is to evaluate whether a drug treats the condition it is expected to treat.
7. If your investigator wants to find the regulations that govern the policy, procedure, and process of the IRB, he/she could reference which of the below parts of the Code of Federal Regulations?
A. 45 CRF part 46
B. 21 CRF part 50
C. 21 CRF part 56
D. ICH Guidelines
8. Recent industry reports indicate the cost to develop one drug and bring it to the marketplace stands at:
A. 100 million
B. 550 million
C. 800 million
D. 1 billion
9. Your Investigator has a large financial interest in a pharmaceutical company that wants to have your site participate in a study of a new drug. From the list below, which would require your Investigator to “check yes” and disclose this interest:
A. $20,000 in stock options of Sponsor
B. $10,000 in speaker fees discussing the Sponsor’s products
C. $50,000 worth of equipment, provided to conduct the trial
D. $75,000 in stock of Sponsor
E. C and D
10. An IRB is required to review studies involving human subjects under FDA regulations but not those under HHS.
11. The IRB at your institution is very strict and has many institutional requirements. When, if ever, is your site allowed to utilize another IRB to review your studies?
A. This is never allowed.
B. Only when this process is pre-approved by your local IRB
C. When approved by the Sponsor
D. When approved by the Investigator
12. According to FDA regulations, the sponsor is responsible for interacting with the IRB in order to ensure human subject protection.
13. The following group(s) may represent a special population and, therefore additional oversight relative to human subject protection:
A. Medical school students
D. B & C
E. All of the above
14. One requirement of appropriate IRB review of clinical research involving humans includes the approval of the IRB chairman and one other scientific member of the committee.
15. Per the FDA Regulations, the IRB is required to conduct continuing review of protocols at least ___________.
B. Every 6 months
C. Based on the risk level of the trial
16. Your doctor wants to treat you with an approved drug for your illness. However, your diagnosis is not listed within the package insert of the medication. Your doctor notes this is considered off-label use. What would your physician need to utilize this therapy?
A. File an IND since the product is not FDA approved for your diagnosis
B. Obtain IRB approval since this is a protocol
C. This is considered the treatment of an individual patient, and the physician may prescribe as deemed appropriate.
D. Sponsor approval to use the drug in an off-label environment
17. Patients often participate in studies seeking treatment for their condition; therefore, its critical that research professionals distinguish study participation as not usually considered “treatment.”
18. Per ICH, the investigator is requested to inform a subject’s primary care physician of study participants provided the subject agrees to this notification.
19. Your subject reports that he has been having headaches for years, but they seem to have become more frequent since starting the study. The PI believes this is not related to the study medication. How would you likely report this event?
A. Does not require reporting since part of the subject’s medical history
B. Adverse event, since the complaint is more frequent.
C. Serious Adverse Event
D. Updated medical history form
20. You enroll someone in a study during her hospitalization. The subject develops pneumonia and has to stay an extra 2 days in the hospital. How is pneumonia reported?
A. SAE because it meets the criteria of prolonging hospitalization
B. Not reported since the subject was already hospitalized
C. Adverse event
D. Updated medical history form
21. If a subject dies while in a study, the sponsor has 24 hours to report this to the FDA.
22. ___________ is the term routinely used to describe any location where original data is recorded.
A. FDA Form 1572
C. Regulatory binder
D. Source document
23. In this lesson, the following items were used to define a successful clinical research professional.
B. Responsive and persistent
C. Only perform those tasks licensed or trained to do
D. All of the above
24. Per FDA Regulations, only a physician can be a sub-investigator.
25. Per FDA and ICH, the _________ is the individual with ultimate responsibility for local study conduct.