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Updated CCRP CBT & Valid CCRP Exam Topics

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SOCRA CCRP Exam Syllabus Topics:

Topic	Details
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.

Topic

Details

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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q26-Q31):

NEW QUESTION # 26
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?

A. A printout of the EDC record
B. A printout of the electronic medical record
C. The electronic medical record
D. The EDC record

Answer: D

Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51:Defines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).

NEW QUESTION # 27
During the closeout visit, a monitor is completing the documentation of reconciliation of investigational product. All packaging, as well as the used and unused investigational product, are being returned to the sponsor for disposition. Which of the following documents wouldNOTbe required to be filed at the research site?

A. Investigational product accountability forms
B. A certificate of investigational product destruction
C. Records of investigational product shipment
D. Investigational product inventory forms

Answer: B

Explanation:
Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).
* ICH E6(R2) 4.6.3:Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.
* ICH E6(R2) 8.2.14-8.2.16:Essential documents include shipment records, accountability logs, and inventory records.
However,certificates of destructionare generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.
Thus, the correct answer isD (Certificate of destruction).
References:
ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §8.2.14-8.2.16 (Essential documents).

NEW QUESTION # 28
A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?

A. The protocol
B. The data safety monitoring plan
C. The informed consent document
D. The Investigator's Brochure

Answer: A

Explanation:
Theprotocolgoverns all trial conduct, including whether subjects should be replaced when they withdraw.
* ICH E6(R2) 6.0:The protocol must contain "detailed information on trial design, methodology, statistical considerations, and the organization of the trial."
* ICH E6(R2) 6.9.2:The section on "Subject withdrawal or discontinuation" specifies "whether and under what conditions subjects may be replaced." Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only theprotocolprovides the operational answer regarding replacement.
Thus, the correct answer isB (The protocol).
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).

NEW QUESTION # 29
According to the CFR, when children who are wards of the state are enrolled into a clinical trial, what is required?

A. Assenting children must self-represent
B. The investigator must represent the children
C. The IRB/IEC must include a member who advocates for the children
D. Each child must have a patient advocate

Answer: C

Explanation:
Children who are wards of the state receiveadditional protectionsin clinical research.
* 45 CFR 46.409(b):For research involving wards, "the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided."
* The advocate must have background and experience to act in the child's best interest and cannot be associated with the research.
Thus, anIRB-appointed advocateis mandatory to ensure independent representation of the ward's rights.
References:45 CFR 46.409(b).

NEW QUESTION # 30
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?

A. Record storage plan
B. Case report forms
C. List of potential subjects
D. Recruitment materials

Answer: D

Explanation:
* ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.
* CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.
References:ICH E6(R2) §3.1.2; FDA Recruitment Guidance, 1998.

NEW QUESTION # 31
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