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SOCRA CCRP Exam Questions
- Topic 1: Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.
- Topic 2: Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
- Topic 3: Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.
Free SOCRA CCRP Exam Actual Questions
Note: Premium Questions for CCRP were last updated On Apr. 07, 2026 (see below)
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.
21 CFR 56.111(a)(3): The IRB must ensure that subject selection is equitable.
21 CFR 50.25(a)(3): Requires disclosure of ''any compensation and/or medical treatments available if injury occurs.''
ICH E6(R2) 4.8.10(n): Informed consent should describe ''any compensation and/or reimbursement to subjects.''
Thus, compensation amounts must be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.
Correct answer: B (The amount of payments and compensation to subjects).
21 CFR 50.25(a)(3).
ICH E6(R2), 4.8.10(n).
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
21 CFR 56.109(a): IRBs must review all changes to informed consent before implementation.
ICH E6(R2) 4.8.2: If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.
Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
Minimal risk determination is a regulatory function of the IRB/IEC.
45 CFR 46.102(j): Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
45 CFR 46.109(a): The IRB has authority to approve, require modifications, or disapprove research, including assessment of risk level.
Investigators may propose a study as minimal risk, but only the IRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, Which option best is responsible for providing the audit certificate to the clinical site?
Audits are part of sponsor quality assurance to ensure trial compliance.
ICH E6(R2) 5.19.3: ''The sponsor's auditing procedures should include the provision of an audit certificate where required.''
ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.
IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.
Correct answer: D.
ICH E6(R2), 5.19.3.
ICH E6(R2), 8.2.20.
In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
The investigator has ultimate responsibility for site staff qualifications.
ICH E6(R2) 4.2.4: ''The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions.''
ICH E6(R2) 4.1.5: Investigator must maintain current documentation of staff qualifications.
While sponsors and monitors oversee compliance, accountability rests with the clinical investigator. Coordinators may implement duties, but do not hold legal responsibility.
Correct answer: B (The clinical investigator).
ICH E6(R2), 4.2.4.
ICH E6(R2), 4.1.5.
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