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1. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
A) There are no circumstances under which this person can be enrolled.
B) Locate a translator and have them work with the person.
C) Get an impartial witness involved in consenting this person.
D) Have the Principal Investigator consent the person.
2. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?
A) Accept this site and implement and maintain QA and QC systems with written SOPs.
B) Accept this site and plan to undertake routine safety evaluations of the IP.
C) Before accepting this site, report the risk to the trial sponsor and await their decision.
D) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
3. Which statement does NOT represent a study monitor's responsibilities?
A) Provide communication between the sponsor and the PI.
B) Verify that the PI has adequate qualifications and resources to conduct the study.
C) Check the accuracy and completeness of case report forms with source documents.
D) Report serious adverse events to the IRB/IEC.
4. Which of the following should be considered when implementing a risk-based monitoring plan?
A) On-site monitoring frequency may change depending on the quality of the data.
B) Centralized monitoring must be incorporated in any trials.
C) Monitoring schedule must be pre-defined in the monitoring plan.
D) 100% source document review is mandatory.
5. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A) Register IP in IWRS, quarantine and notify sponsor of the excursion.
B) Quarantine IP without registering in IWRS and request replacement from sponsor.
C) Register IP in IWRS and continue with subject allocation.
D) Dispose of IP and request replacement from sponsor.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: A | Question # 5 Answer: A |
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