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How to Prepare For CCRP Certified Clinical Research Professional (CCRP)?

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SOCRA CCRP Exam Syllabus Topics:

Topic
Details

Topic 1

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.

Topic 2

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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q110-Q115):

NEW QUESTION # 110
In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB/IEC for review?

A. The sponsor
B. The Food and Drug Administration
C. The investigator
D. The contract research organization

Answer: C

Explanation:
Theinvestigatorbears direct responsibility for ensuring IRB/IEC review and approval before initiating a study or implementing any amendments.
* ICH E6(R2) 4.4.1:"Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, and any other written information to be provided to subjects."
* 21 CFR 312.66:"An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study." While sponsors may provide protocol documents, the legal obligation to submit and maintain IRB/IEC approval rests with the investigator at each site. CROs act under sponsor delegation but cannot replace investigator accountability.
Thus, the correct answer isB (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibilities).
21 CFR 312.66 (Investigator assurance of IRB oversight).

NEW QUESTION # 111
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?

A. Clinical investigator
B. Sponsor
C. IRB/IEC
D. Program manager

Answer: A

Explanation:
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties."This responsibility cannot be delegated to sponsor or IRB.
References:ICH E6(R2), §4.2.4.

NEW QUESTION # 112
Which case history documents must be at both sponsor and site?

A. Study visit notes
B. Case report forms (CRFs)
C. Medical records
D. Signed informed consent forms

Answer: B

Explanation:
* ICH E6(R2) 1.11:CRFs are documents used to record protocol-required data reported to sponsor.
* Sites keep originals; sponsor retains copies.Consent forms and medical records stay at site only.
References:ICH E6(R2), §1.11.

NEW QUESTION # 113
Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

A. 492 mg/m²
B. 444 mg/m²
C. 400 mg/m²
D. 420 mg/m²

Answer: B

Explanation:
370 × 1.20 =444 mg/m².
Accurate dosing calculations are critical for protocol adherence and patient safety.
References:Standard pharmacology dose adjustment principles; ICH E6(R2) §4.5.1.

NEW QUESTION # 114
Upon completion of a study, the investigator should do which of the following?

A. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
B. Provide the IRB/IEC a final report, but only if the study has a positive outcome
C. Ensure that all payments from sponsor have been received
D. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome

Answer: D

Explanation:
Investigators must formally close out a trial with the IRB/IEC.
* ICH E6(R2) 4.13.2:"Upon completion of the trial, the investigator/institution should provide the IRB
/IEC with a summary of the trial's outcome."
* 21 CFR 312.66:Reinforces investigator's duty to keep IRB informed throughout study lifecycle.
This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).
Thus, the correct answer isA (Provide final report to IRB/IEC).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).

NEW QUESTION # 115
......

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