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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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q87-Q92):

NEW QUESTION # 87
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. A certificate of investigational product destruction
B. Investigational product inventory forms
C. Investigational product accountability forms
D. Records of investigational product shipment

Answer: A

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 # 88
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

A. IRB/IEC requirements for reporting to the regulatory authority
B. Sponsor's SOPs
C. Requirements for storage of the investigational product
D. Written information to be provided to the subjects

Answer: A

Explanation:
Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.
* ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.
* Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).
However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor's scope.
That responsibility lies with investigators and IRBs under21 CFR 56.108(b).
Thus, the correct answer isD.
References:
ICH E6(R2), §5.18.4.
21 CFR 56.108(b).

NEW QUESTION # 89
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?

A. The study coordinator
B. The IRB/IEC
C. The institutional administrator
D. The sponsor

Answer: D

Explanation:
* ICH E6(R2) 5.2.1:"The sponsor is responsible for implementing and maintaining quality assurance and quality control systems... including allocation of trial-related duties."
* Although tasks may be delegated to CROs or site staff, accountability remains with thesponsor.
References:ICH E6(R2), §5.2.1.

NEW QUESTION # 90
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?

A. At least weekly
B. Once a year until study close-out
C. Every 4-6 weeks until study close-out
D. In a timely manner before, during, and after the study

Answer: D

Explanation:
Monitoring ensures trial integrity and subject safety.
* ICH E6(R2) 5.18.3:"The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial."
* Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).
It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.
Correct answer:C (Timely manner before, during, and after).
References:
ICH E6(R2), §5.18.3.

NEW QUESTION # 91
A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?

A. A brochure from the training course
B. An updated performance review summary
C. An updated curriculum vitae
D. The letter documenting the promotion to a CRC

Answer: C

Explanation:
The regulatory binder (investigator site file) must contain documents verifying qualifications of all personnel.
These include curricula vitae (CVs), professional licenses, and training certificates.
ICH E6(R2) 4.1.5: "The investigator should ensure that all persons assisting with the trial are qualified by education, training, and experience... Current curriculum vitae and/or other relevant documents evidencing qualifications should be maintained."
21 CFR 312.53(c)(1): Sponsors must select investigators qualified "by training and experience," and investigators must provide sufficient documentation, typically updated CVs.
Letters of promotion (A), training brochures (B), or performance reviews (C) may remain in personnel files but are not required regulatory documents. The only acceptable regulatory proof is an updated CV (D), which reflects the individual's training and qualifications for their new role.
Therefore, the correct answer is D (Updated CV). This ensures compliance with ICH and FDA requirements for staff qualification documentation in clinical research.
References:
ICH E6(R2) Good Clinical Practice, §4.1.5 (Investigator responsibilities for staff qualification).
21 CFR 312.53(c)(1) (Investigator qualifications and documentation).

NEW QUESTION # 92
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