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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 Sep. 06, 2026 (see below)
Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
India has aligned national regulations with ICH-GCP.
DCGI/ICMR Guidelines (India): Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.
China and Brazil are harmonizing, but full official adoption is noted in India.
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?
21 CFR 56.109(a): IRB must review and approve any protocol amendments before implementation.
ICH E6(R2) 4.5.2: Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtain IRB approval for revised protocol and ICF.
An approved investigational device exemption (IDE) permits a device to be:
An Investigational Device Exemption (IDE) allows an unapproved medical device to be used in a clinical investigation.
21 CFR 812.1(a): ''An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.''
It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).
Thus, the correct answer is A (Shipped lawfully for clinical study).
21 CFR 812.1(a) (IDE exemption provisions).
After completion of a Phase III trial, which document should IRB/IEC retain?
21 CFR 56.115(a)(5): IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
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).
21 CFR 312.44(b)(1) (Termination of an IND).
21 CFR 312.42(e) (Clinical hold procedures).
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