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Weekly GCP Challenge

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Challenge: ICH GCP General Questions IV

Question Number 1:
According to ICH GCP before a trial is initiated what should be weighed against the anticipated benefit for the individual trial subject and society?
A
 potential dangers and costs
B
 foreseeable risks and inconveniences
C
 anticipated harm
D
 safety concerns and time requirements

Question Number 2:

Which of the following according to ICH GCP should guide the sponsor's audit plan and procedures for a trial audit?

  1. the importance of the trial to submissions to regulatory authorities
  2. the number of subjects in the trial
  3. the type and complexity of the trial
  4. the level of risk to trial subjects
  5. any identified problems
A
 None of them
B
 2, 3 and 4 only
C
 3 and 4 only
D
 All of them

Question Number 3:
According to ICH GCP what should the investigator do when they have prematurely unblinded the investigational product(s) for a subject?
A
 Withdraw the subject from the trial
B
 Promptly document and explain to the sponsor
C
 Ensure the minimum number of people know what the unblinded investigational products(s) is/are
D
 Complete a protocol violation form

Question Number 4:

According to ICH GCP the IRB/IEC should establish and document in writing and follow procedures for which of the following:

  1. Determining its composition
  2. Scheduling, notifying its members of, and conducting its meetings
  3. Determining the frequency of continuing review, as appropriate
  4. Training and Assessment for its members
A
 1 and 2 only
B
 1, 2 and 3 only
C
 1, 3 and 4 only
D
 All of them

Question Number 5:

According to ICH GCP which of the following may a sponsor consider establishing to assess the progress of a trial , including the safety data and critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify or stop a trial?
A
 IEC
B
 IRB
C
 IDMC
D
 Steering Committee

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