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SOCRA CCRP Exam Prep
Certified Clinical Research Professional (Page 12 )

Updated On: 29-Aug-2026
Page 5 of 27
PDF with 130 Questions

An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?

  1. The investigator/institution and the sponsor
  2. The investigator/institution and the delegated site staff
  3. The sponsor and the IRB/IEC
  4. The sponsor and the FDA

Answer(s): A

Explanation:

The protocol signature page documents agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.

ICH E6(R2) 8.2.2 (Signed protocol and amendments): Requires "the sponsor and investigator/institution to sign the protocol and amendments, confirming agreement."

ICH E6(R2) 4.5.1: "The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC."

The sponsor­investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols. These bodies approve or oversee, but do not formally enter into execution of the protocol.

Thus, the correct answer is A (The investigator/institution and the sponsor).


Reference:

ICH E6(R2), §8.2.2 (Signed protocol and amendments).

ICH E6(R2), §4.5.1 (Investigator compliance with protocol).



A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?

  1. Number of staff members
  2. Available storage square footage
  3. Storage facility temperature range
  4. Storage cost

Answer(s): C

Explanation:

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3: "The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s)."

ICH E6(R2) 4.6.4: "The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol."

During site qualification/selection, the monitor evaluates storage conditions -- particularly temperature ranges -- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer is C (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.


Reference:

ICH E6(R2), §5.13.3 (Product storage requirements).

ICH E6(R2), §4.6.4 (Investigator product storage responsibilities).



Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?

  1. A plan for the publication of study results is in place
  2. The selection of subjects is equitable
  3. The investigator has adequate access to patients eligible for the trial
  4. The sponsor is qualified to provide oversight of the trial

Answer(s): B

Explanation:

IRB/IEC review focuses on ethical protection of human subjects. Equitable subject selection is a cornerstone principle.

45 CFR 46.111(a)(3): "In order to approve research... the IRB shall determine that: Selection of subjects is equitable."

ICH E6(R2) 3.1.2: "The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects... with particular attention to trials that may include vulnerable subjects."

Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB's role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.

Thus, the correct answer is B (The selection of subjects is equitable).


Reference:

45 CFR 46.111(a)(3) (Equitable subject selection).

ICH E6(R2), §3.1.2 (IRB/IEC role).



The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?

  1. The sponsor failed to submit an accurate annual report of the study to the FDA
  2. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study
  3. An investigator failed to submit safety reports to the FDA
  4. The FDA issued a clinical hold, and 30 days have elapsed

Answer(s): D

Explanation:

The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.

21 CFR 312.44(b)(1): "The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury."

21 CFR 312.42(e): "If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND."

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed).


Reference:

21 CFR 312.44(b)(1) (Termination of an IND).

21 CFR 312.42(e) (Clinical hold procedures).



Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?

  1. Aplastic anemia requiring hospitalization, mentioned in the investigator's brochure
  2. An infection not related to the investigational drug requiring hospitalization for antibiotic therapy
  3. Death as a result of arrhythmias (irregular heart rhythm), not mentioned in the investigator's brochure and thought to be related to the use of the drug
  4. Death due to disease progression, mentioned in the investigator's brochure

Answer(s): C

Explanation:

Sponsors must report serious, unexpected, and suspected adverse reactions (SUSARs) to the FDA.

21 CFR 312.32(c)(2): "Any adverse experience associated with the use of the drug that is both serious and unexpected shall be reported... as soon as possible but no later than 7 calendar days after the sponsor's initial receipt of the information, if it is fatal or life-threatening."

ICH E2A 4.2: Requires expedited reporting of life-threatening or fatal SUSARs within 7 days.

Among the options, only (C) -- death from arrhythmias not previously identified in the Investigator's Brochure and suspected to be drug-related -- meets the definition of a SUSAR requiring 7-day expedited reporting. Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.

Thus, the correct answer is C.


Reference:

21 CFR 312.32(c)(2) (Expedited safety reporting).

ICH E2A, §4.2 (Expedited reporting of fatal/life-threatening adverse events).



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