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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: ICH GCP General Questions

Question Number 1:

According to ICH GCP when planning trials the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure to which of the following

  1. the route [of administration]
  2. the dosages
  3. the duration
  4. the trial population

 
A
 1 and 2 only
B
 2 and 3 only
C
 2, 3 and 4 only
D
 All of them

Question Number 2:

According to ICH GCP monitors should be "thoroughly familiar" with which of the following:

  1. Investigational Product
  2. Protocol
  3. Written Informed Consent
  4. Sponsor SOPs
  5. GCP
  6. Applicable Regulatory Requirements
A
 2, 4 and 5 only
B
 2, 3, 4 and 5 only
C
 1, 2, 4 and 6 only
D
 All of them

Question Number 3:

Which of the following statements does not appear in ICH GCP in the subject entitled Adequate Resources?
A
 The Sponsor is responsible for ensuring that the investigator has an adequate number of qualified staff and adequate facilities available at all times for the duartion of the trial.
B
 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
C
 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.
D
 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

Question Number 4:

According to ICH GCP which of the following should be included in a monitoring report?

  1. summary of what the monitor reviewed
  2. significant findings/facts
  3. deviations and deficiencies
  4. conclusions
  5. actions taken or recommended to secure compliance
A
 None of them
B
 2, and 3 only
C
 1, 2, 3 and 5 only
D
 All of them

Question Number 5:

ICH GCP states that "Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should .................... while fully respecting the subject's rights". What is missing from the statement?
A
 identify and document the reason(s) where possible
B
 make a reasonable effort to ascertain the reason(s)
C
 make every effort to provide a comprehensive report of the reason(s)
D
 use all available information to explain the withdrawl

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