6. When is the Abbreviated New Drug Submission (ANDS) used?
For generic products
For minor changes in formulation
For brand-name products
For changes in the way of administration
7. In which year was the Declaration of Helsinki originally adopted?
1971
1957
1964
1998
8. Which document allows selling a therapeutic product in Canada?
NOC (Notice Of Compliance)
NOL (No Objection Letter)
NON (Notice of Non-Compliance)
None of the above
9. Which section of the protocol should contain "Medication(s) and treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial"?
Trial Design
Treatment of Subjects
Assessment of Efficacy
Trial Objectives and Purpose
10. Why are preclinical studies important?
To determine pharmacokinetics
All of the above
To determine drug metabolism
To determine drug toxicology
To determine the highest tolerated dose
11. Which set of principles for human research was adopted as a result of the inhumane experiments of Karl Brandt and Josef Mengele on prisoners during WW2?
Nuremberg Code
Informed Consent
Belmont Report
ICH GCP
12. What does FBC stand for?
Ferrous Blood Concentration
Full Blood Count
Full Biochemistry Count
Formal Blood Control
13. The study monitor is responsible for overseeing general health of all subjects and assuring that they meet eligibility criteria
False
True
14. What are Phase II studies usually called
Toxicity study
Efficacy study
Dose ranging study
Confirmatory study
15. Who provides insurance & indemnity to trial subjects in case of trial related injury?
The Medical insurance of the subjects
The Sponsor
The institution of the Investigator, who is responsible for the patient care
The CRO
16. Where are the Canadian requirements for investigational Medical Devices found?
In the Canadian Medical Devices Regulations
In the Food and Drug Act
All of the above
n the ICH GCP Guidelines
17. What are the new Phase 0 studies usually called
Exploratory study
Dose determination study
Confirmatory study
Toxicology study
18. Who usually participates in Phase I clinical trials?
About 80-100 patients with the target disease
Less than 100 healthy voluntary subjects.
Small number of voluntary patients
100-200 healthy voluntary subjects
19. What are the usual timelines for a non-commercial Ethics Committee Approval ?
60 to 90 days
30 days
30 to 60 days
120 days
20. Monitors are required by GCP to inform investigators of observed deficiencies during the monitoring process and define the actions, necessary by the investigator to correct the observed deficiencies.
