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??
A.
The sponsor
B.
The investigator/institution
C.
The IRB/IEC
D.
The external source
Correct Answer: B
Explanation:
The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and
ensuring qualified, trained staff—regardless of employment source. Exact extracts:
ICH E6(R2) 4.1.1: “The investigator should be qualified… and have adequate resources to properly
conduct the trial.”
ICH E6(R2) 4.1.5: “The investigator should ensure that all persons assisting with the trial are
adequately informed about the protocol, the investigational product(s), and their trial-related duties
and functions.”
ICH E6(R2) 4.2.5: “The investigator may delegate… but retains responsibility for the conduct of the
trial at the site.”
Therefore, the investigator/institution (B) must implement procedures and oversight to maintain
integrity of trial duties.
Reference:
ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and
oversight).
Question #2 (Topic: demo questions)
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:
A.
Suspend all trial-related activities until the events of the deviation have been mitigated
B.
Document and explain the deviation from the protocol
C.
Assign another investigator to perform sample collections until an internal investigation is completed
D.
Immediately report the observation to the regulatory authority
Correct Answer: B
Explanation:
ICH directs investigators to document and explain any deviation, with prompt reporting to IRB/IEC
only when deviations are implemented to eliminate immediate hazards or as required. Exact
extracts:
ICH E6(R2) 4.5.3: “The investigator should document and explain any deviation from the approved
protocol.”
ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported
as soon as possible.
Here, absent immediate hazard, the required action is documentation and explanation (B).
Reference:
ICH E6(R2) Good Clinical Practice, §4.5.3 (Compliance with protocol; deviations).
ICH E6(R2) §3.3.7; §4.5.2 (Reporting deviations implemented to eliminate immediate hazards).
Question #3 (Topic: demo questions)
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?
A.
The investigator
B.
The IRB/IEC
C.
The CRO
D.
The sponsor
Correct Answer: D
Explanation:
Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract: ICH E6(R2)
5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,
but the ultimate responsibility for the quality and integrity of the trial data always resides with the
sponsor.” Hence, D is correct. Reference: ICH E6(R2) Good Clinical Practice, §5.2.1 (Sponsor/CRO).
Question #4 (Topic: demo questions)
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?
A.
Immediately
B.
Within 7 working days
C.
Within 10 working days
D.
Within 15 working days
Correct Answer: A
Explanation:
ICH requires immediate reporting of all SAEs to the sponsor (except those protocol-identified as not
requiring immediate reporting). Exact extract:
ICH E6(R2) 4.11.1: “The investigator should report all serious adverse events immediately to the
sponsor except for those SAEs that the protocol… identifies as not needing immediate reporting.”
Therefore, “Immediately” (A) is correct. The other timeframes are not aligned with ICH GCP for initial
SAE notification from investigator to sponsor.