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GCP Tests

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: RESEARCH

Question Number 1:
What words are missing from the following statement in ICH GCP: For XXXX the investigator should supply the sponsor and the IRB/IEC with any additional requested information?
A
 reported adverse events
B
 reported serious adverse events
C
 reported SUSARs
D
 reported deaths

Question Number 2:
What completes the ICH GCP wording: In obtaining and documenting informed consent the investigator should comply with the applicable regulatory requirements and should adhere to GCP and to the XX that have their origin in the Declaration of Helsinki?
A
 ethical approvals
B
 ethical considerations
C
 ethical principles
D
 ethical requirements

Question Number 3:
What completes the statement from ICH GCP: When using electronic trial data handling and/or remote electronic trial data systems the sponsor should maintain XXX for using these systems.
A
 SOPs
B
 Standards
C
 Specific Validation Records
D
 Security and Backup procedures

Question Number 4:
Section 5.18.3 in ICH GCP has the title:
A
 Evaluation and Specifics of Monitoring
B
 Extent and Nature of Monitoring
C
 Ethical Requirements of Monitoring
D
 Evaluation and Nature of Monitoring

Question Number 5:
Approval is defined in ICH GCP as: The XXXX of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, GCP and the regulatory requirements.
A
 approved decision
B
 appropriate decision
C
 affirmative decision
D
 acceptable decision

Question Number 6:
What words complete the statement in ICH GCP: The sponsor should determine for investigational products acceptable storage temperatures, storage conditions, storage times, XXXXX, and devices for product infusion, if any.
A
 resupply procedure
B
 relabelling and randomisation methods
C
 reconstitution fluids and procedures
D
 return storage conditions

Question Number 7:
Complete this statement from ICH GCP: neither the investigator, nor the trial staff, should XXX or unduly influence a subject to participate or to continue to participate in a trial.
A
 convince
B
 coerce
C
 compel
D
 change the opinion

Question Number 8:
Complete the statement from ICH GCP: Specifying that the investigator should promptly report to the IRB/IEC deviations from or changes of the protocol to eliminate immediate XX to the trial subjects.
A
 harm
B
 hospitalisation
C
 hazards
D
 harmful effects

 
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