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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.

Test: ICH GCP General Questions II

Question Number 1:

According to the Monitor's Responsibilities section of ICH GCP which of the following should be "clearly reported on the CRF"

  1. visits that the subject fails to make
  2. tests that are not conducted
  3. examinations that are not performed
A
 1 and 3 only
B
 1 and 2 only
C
 2 and 3 only
D
 1, 2 and 3

Question Number 2:

According to ICH GCP which of the following should be explained in the informed consent discussion and written informed consent?

  1. The subject's responsibilities
  2. The approximate number of subjects involved in the trial
  3. The aspects of the trial that are experimental
  4. The trial treatment(s) and the probability for random assigment to each treatment
A
 1 only
B
 1 and 3 only
C
 1, 2 and 4 only
D
 All of them

Question Number 3:

According to ICH GCP when using electronic trial data handling and/or remote electronic trial data systems the sponsor should:

  1. Maintain SOPs for using these systems
  2. Ensure that the systems are designed to permit data changes in such a way that data changes are documented and there is no deletion of entered data
  3. Maintain adequate backup of the data
  4. Safeguard the blinding
A
 1 and 3 only
B
 1 and 4 only
C
 1, 2 and 3 only
D
 All of them

Question Number 4:

According to ICH GCP if the sponsor discontinues the clinical development of an investigational product who should they notify?

  1. all the regulatory authorities
  2. all the trial investigators/institutions
  3. all the subjects
  4. all the IRBs/IECs
A
 1 only
B
 1 and 2 only
C
 1 and 4 only
D
 All of them

Question Number 5:

According to ICH GCP which of the following statements are true about record retention?

  1. The sponsor should inform the investigator in writing of the need for record retention
  2. The sponsor should notify the investigator in writing when the trial related records are no longer needed
  3. It is the responsibility of the investigator to notify the IRB/IEC when the trial related records are no longer needed
A
 1 only
B
 1 and 2 only
C
 All of them
D
 None of them

 
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