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SOCRA CCRP Practice Test Questions Answers

Exam Code: CCRP (Updated 130 Q&As with Explanation)
Exam Name: Certified Clinical Research Professional (CCRP)
Last Update: 07-Dec-2025
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Questions Include:

  • Single Choice: 130 Q&A's

  • CCRP Overview

    Other SOCRA Exams

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    CCRP Questions and Answers

    Question # 1

    In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:

    A.

    Printed, signed, and dated

    B.

    Managed within a validated computer system

    C.

    Entered into an electronic case report form

    D.

    Restricted to authorized clinical trial personnel

    Question # 2

    A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?

    A.

    The data safety monitoring plan

    B.

    The protocol

    C.

    The Investigator's Brochure

    D.

    The informed consent document

    Question # 3

    A sponsor is permitted to charge for an investigational drug but must provide what documentation?

    A.

    CMS approval letter

    B.

    Orphan product evidence

    C.

    IRB attestation of institutional cost burden

    D.

    Evidence of potential clinical benefit and significant advantage

    Question # 4

    A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:

    A.

    Phase I

    B.

    Phase II

    C.

    Phase III

    D.

    Phase IV

    Question # 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?

    A.

    The sponsor

    B.

    The investigator/institution

    C.

    The IRB/IEC

    D.

    The external source

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