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The SOCRA CCRP pdf questions learning material provided to the customers from Braindumpsqa is in three different formats. The first format is PDF format which is printable and portable. It means it can be accessed from tablets, laptops, and smartphones to prepare for the Certified Clinical Research Professional (CCRP) exam. The SOCRA CCRP Pdf Format can be used offline, and candidates can even prepare for it in the classroom or library by printing questions or on their smart devices.

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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q108-Q113):

NEW QUESTION # 108
In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?

A. The addition of a new test that is intended to improve monitoring the subject for an adverse effect
B. The addition of a sub-investigator with the scientific training and expertise to conduct the investigation
C. A significant change in an investigator's financial interest in the investigational product
D. A change in the manufacturing site for the investigational product

Answer: D

Explanation:
The U.S. Code of Federal Regulations (CFR) specifies when sponsors must notify FDA of changes to investigational drug studies under 21 CFR 312.30. A protocol amendment is required if there is:
A change to the protocol (e.g., objectives, design, subject population, dosing, or procedures).
The addition of a new investigator.
A change in the chemistry, manufacturing, or controls (CMC) that could significantly affect product quality or safety.
Among the listed options, a change in the manufacturing site (D) directly falls under significant manufacturing changes, requiring FDA submission. Changes in investigator financial interests (B) are covered under 21 CFR 54 and reported separately, not as protocol amendments. Addition of a sub-investigator (C) does not require a formal amendment, only site-level documentation and delegation log update. Addition of a monitoring test (A) may affect the protocol, but not necessarily mandate an amendment unless it changes objectives or subject safety endpoints.
Therefore, the correct answer is D. This ensures FDA oversight of product safety, efficacy, and compliance with CMC standards before investigational use.
References:
21 CFR 312.30 (Protocol amendments).
21 CFR 312.23(a)(7) (Chemistry, manufacturing, and controls information).

NEW QUESTION # 109
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?

A. The protocol
B. Staff training
C. Adequate resources
D. Proper equipment

Answer: A

Explanation:
Before an investigator can commit to conducting a trial, they must review thestudy protocol.
* ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.
* ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator's brochure and the current approved protocol.
Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.
References:ICH E6(R2), §§4.2.3, 4.5.1.

NEW QUESTION # 110
For a Significant Risk device study, an investigator must report within 5 working days which event?

A. Withdrawal of FDA approval
B. Emergency deviation
C. Unanticipated adverse effect
D. Completion of investigation

Answer: B

Explanation:
* 21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well- being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.
* Unanticipated adverse device effects have a 10-day reporting window.
References:21 CFR 812.150(a)(4).

NEW QUESTION # 111
In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:

A. 15 years
B. 2 years
C. 3 years
D. 5 years

Answer: B

Explanation:
TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57 (c)and21 CFR 312.62(c).
* 21 CFR 312.57(c):"A sponsor shall retain the records and reports... for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified."
* 21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.
This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.
Thus, the correct answer isA (2 years).
References:
21 CFR 312.57(c) (Sponsor record retention).
21 CFR 312.62(c) (Investigator record retention).

NEW QUESTION # 112
A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?

A. The sponsor
B. The site's legal counsel
C. The IRB/IEC
D. The clinical investigator

Answer: C

Explanation:
Therisk-benefit ratiois a core responsibility of the IRB/IEC.
* 21 CFR 56.111(a)(2):"Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result."
* ICH E6(R2) 3.1.2:IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.
Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.
Thus,IRB/IEC is directly responsible for approving the risk-benefit ratio.
References:
21 CFR 56.111(a)(2).
ICH E6(R2), §3.1.2.

NEW QUESTION # 113
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