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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: Informed Consent - Missing Words

Question Number 1:
In ICH guidance on content of informed consent which words are missing from the following: "The trial procedures to be followed, including .........."
A
 the number of visits
B
 all invasive procedures
C
 all non-routine procedures
D
 the number and type of samples to be obtained

Question Number 2:
In ICH guidance on content of informed consent which word(s) is/are missing from the following: "The trial treatments and the probability for ......."
A
 Adverse Events
B
 Treatment failure
C
 random assignment to each treatment
D
 placebo control

Question Number 3:
In ICH guidance on content of informed consent which word(s) is/are missing from the following: "That the subject's participation in the trial is ......."
A
 subject to investigator approval
B
 of benefit to future patients
C
 essential
D
 voluntary

Question Number 4:
In ICH guidance on content of informed consent which word(s) is/are missing from the following: "That records identifying the subject will be ......."
A
 kept confidential
B
 made publicly available
C
 subject to review by regulatory authorities
D
 kept for 15 years

Question Number 5:
In ICH guidance on content of informed consent which word(s) is/are missing from the following: "The approximate ......."
A
 duration of the trial
B
 number of assessments
C
 time of publication of results
D
 number of subjects involved in the trial

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