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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 - The Protocol

Question Number 1:
According to ICH GCP which section of the protocol should contain "A description of the measures taken to minimize/avoid bias"?
A
 Trial Objectives and Purpose
B
 Trial Design
C
 Assessment of Efficacy
D
 Statistics

Question Number 2:
According to ICH GCP which section of the protocol should contain "Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial"?
A
 Trial Objectives and Purpose
B
 Trial Design
C
 Treatment of Subjects
D
 Assessment of Efficacy

Question Number 3:
According to ICH GCP which section of the protocol should contain "Criteria for the termination of the trial"?
A
 Trial Objectives and Purpose
B
 Trial Design
C
 Treatment of Subjects
D
 Statistics

Question Number 4:
According to ICH GCP which section of the protocol should contain "Procedures for eliciting reports of and for recoding and reporting adverse event and intercurrent illnesses"?
A
 Trial Objectives and Purpose
B
 Trial Design
C
 Treatment of Subjects
D
 Assessment of Safety

Question Number 5:
According to ICH GCP which section of the protocol should contain "procedure for accounting for missing, unused and spurious data"?
A
 Trial Design
B
 Assessment of Efficacy
C
 Assessment of Safety
D
 Statistics

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