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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 Mar. 01, 2026 (see below)
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.
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. The Subject Identification Code List is a key essential document for ensuring traceability while maintaining confidentiality.
ICH E6(R2) 8.3.21: ''Subject Identification Code List --- A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.''
ICH E6(R2) 8.4: Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. The subject code list ensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer is B (Completed Subject Identification Code List).
ICH E6(R2), 8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), 8.4 (Essential documents for trial closure).
Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?
The Belmont Report (1979), issued by the U.S. National Commission, identifies three core ethical principles guiding human subject research:
Respect for Persons (informed consent, autonomy, protection of vulnerable populations).
Beneficence (maximize benefits, minimize harms).
Justice (fairness in subject selection and treatment).
The Nuremberg Code (1947) was developed post-WWII to prevent unethical experiments.
The Declaration of Helsinki (1964, updated) is a World Medical Association document guiding international physician research ethics.
The ICH Guidelines (1996) outline harmonized regulatory requirements for good clinical practice.
Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.
Thus, the correct answer is D (The Belmont Report).
The Belmont Report (1979), National Commission for the Protection of Human Subjects.
45 CFR 46 (Human Subject Protections).
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?
Investigators are obligated to inform subjects of new information that may affect their willingness to continue.
ICH E6(R2) 4.8.2: ''If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner.''
21 CFR 50.25(b)(5): Consent must include a statement that ''significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided.''
Thus, the investigator must communicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer: C.
ICH E6(R2), 4.8.2.
21 CFR 50.25(b)(5).
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