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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q117-Q122):

NEW QUESTION # 117
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB
/IEC will conduct the initial and continuing review of a study?

Answer: C

Explanation:
Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.
* ICH E6(R2) 4.4.1:"Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects."
* 21 CFR 312.66:"An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study." This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.
Thus, the correct answer isC (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibility before initiation).
21 CFR 312.66 (IRB responsibility in clinical investigations).


NEW QUESTION # 118
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

Answer: B

Explanation:
Sponsors are responsible for distributing safety updates across all investigators and the FDA.
* 21 CFR 312.55(b):"The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug." Other responsibilities fall elsewhere:
* Case histories (C) are maintained by investigators (21 CFR 312.62(b)).
* Progress reports to IRBs (D) are the investigator's duty (21 CFR 312.66).
* Administration of investigational drug (A) is managed by the investigator at site level.
Thus, the correct answer isB (Ensuring FDA and investigators are promptly informed).
References:
21 CFR 312.55(b) (Sponsor notification requirements).


NEW QUESTION # 119
Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?

Answer: D

Explanation:
* Belmont Report:"Respect for Persons" incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).
* Prisoners require special safeguards because of restricted liberty and potential coercion.
References:Belmont Report (1979).


NEW QUESTION # 120
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:

Answer: D

Explanation:
ICH directs investigators todocument and explainany 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 deviationfrom 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).
References:
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).


NEW QUESTION # 121
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?

Answer: D

Explanation:
Before an investigator can commit to conducting a trial, they must review thestudy protocol.
* ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.
* ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator's brochure and the current approved protocol.
Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.
References:ICH E6(R2), §§4.2.3, 4.5.1.


NEW QUESTION # 122
......

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