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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 Jul. 06, 2026 (see below)
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).
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
ICH E6(R2) 5.6.1: ''The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial.''
This ensures transparency in compensation, reimbursement, and budget.
An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?
The Investigator's Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.
ICH E6(R2) 7.3: ''The sponsor should revise the IB as soon as new, significant information becomes available.''
ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.
Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.
Thus, the correct answer is D (No notification is required).
ICH E6(R2), 7.3 (Updating the Investigator's Brochure).
ICH E6(R2), 4.1.5 (Investigator responsibilities for informing staff).
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