2026 SOCRA CCRP: Updated New Certified Clinical Research Professional (CCRP) Exam Simulator

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SOCRA CCRP Exam Syllabus Topics:

TopicDetails
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.|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 2
  • 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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q71-Q76):

NEW QUESTION # 71
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

Answer: B

Explanation:
* 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 obtainIRB approval for revised protocol and ICF.
References:21 CFR 56.109(a); ICH E6(R2) §4.5.2.


NEW QUESTION # 72
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?

Answer: A

Explanation:
The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid... when considering the adequacy and completeness of the written information to be provided to the subjects."
* 21 CFR 56.109(b):"The IRB shall require that information given to subjects as part of informed consent is in accordance with §50.25.The IRB may require that information, in addition to that specifically mentioned in §50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects." This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.
Thus, the correct answer isA (At any time, at the discretion of the IRB/IEC).
References:
ICH E6(R2), §3.1.2 (IRB responsibilities).
21 CFR 56.109(b) (IRB review of informed consent).


NEW QUESTION # 73
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?

Answer: A

Explanation:
Theinformed consent processmust include all basic elements listed in federal regulations.
* 21 CFR 50.25(a)(4):Requires "a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject."
* ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.
This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.
Incorrect options:
* A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.
* B: Financial disclosures may be required for IRB review, not subject-facing.
* C: Subjects do receive a copy, but it is not a required consentelementin regulations.
Correct answer:D.
References:
21 CFR 50.25(a)(4).
ICH E6(R2), §4.8.10(c).


NEW QUESTION # 74
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?

Answer: A

Explanation:
The sponsor holds ultimate responsibility for trial oversight and compliance.
* ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must "take prompt action to secure compliance" and, if necessary, terminate participation of the investigator/institution.
* 21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.
While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.
References:ICH E6(R2) §5.20.1; 21 CFR 312.56(b).


NEW QUESTION # 75
According to ICH GCP, an electronic data capture (EDC) system must:

Answer: A

Explanation:
* ICH E6(R2) 5.5.3(g):Requires audit trails for any data changes, recording date, time, and person responsible.This ensures traceability and regulatory compliance.
Other restrictions (B-D) are not mandated under ICH.
References:ICH E6(R2), §5.5.3(g).


NEW QUESTION # 76
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