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Exam Overview
Exam Code CCRP
Exam Name Certified Clinical Research Professional (CCRP)
Vendor SOCRA
Total Questions 130
Last Updated 26-Oct, 2026
Free CCRP Questions Get Premium Access
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Free CCRP Practice Questions

Explore 4 free practice questions for the SOCRA CCRP exam and review the answers and explanations to support your preparation.

  1. Question 1

    Single answer

    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??

    • Option A:
      The sponsor
      Correct
    • Option B:
      The investigator/institution
      Correct
    • Option C:
      The IRB/IEC
      Correct
    • Option D:
      The external source
      Correct
    Show Answer & Explanation Hide Answer & Explanation

    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).

  2. Question 2

    Single answer

    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:

    • Option A:
      Suspend all trial-related activities until the events of the deviation have been mitigated
      Correct
    • Option B:
      Document and explain the deviation from the protocol
      Correct
    • Option C:
      Assign another investigator to perform sample collections until an internal investigation is completed
      Correct
    • Option D:
      Immediately report the observation to the regulatory authority
      Correct
    Show Answer & Explanation Hide Answer & Explanation

    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).

  3. Question 3

    Single answer

    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?

    • Option A:
      The investigator
      Correct
    • Option B:
      The IRB/IEC
      Correct
    • Option C:
      The CRO
      Correct
    • Option D:
      The sponsor
      Correct
    Show Answer & Explanation Hide Answer & Explanation

    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).

  4. Question 4

    Single answer

    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?

    • Option A:
      Immediately
      Correct
    • Option B:
      Within 7 working days
      Correct
    • Option C:
      Within 10 working days
      Correct
    • Option D:
      Within 15 working days
      Correct
    Show Answer & Explanation Hide Answer & Explanation

    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.