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Question No 1

Which of the following is an example of an additional protection required when conducting research on children?

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There must be an impartial advocate present during the consent process

The investigator must obtain age - appropriate assent as determined by the IRB/IEC

Parents must be present during all procedures

The study must be approved by a central pediatric IRB

Question No 2

A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?

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Question No 3

In accordance with the ICH GCP Guideline, when a sponsor transfers trial - related duties and functions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?

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Question No 4

During an internal compliance review, the site study team identified that a protocol - required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should

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Suspend all trial - related activities until the events of the deviation have been mitigated

Document and explain the deviation from the protocol

Assign another investigator to perform sample collections until an internal investigation is completed

Immediately report the observation to the regulatory authority

Question No 5

A coordinator for an ongoing industry - sponsored, multi - site Phase II clinical trial is taking an unexpected, long - term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial - related duties?

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