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[Hardware] CCRP Valid Practice Questions, CCRP Valid Exam Pdf

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【Hardware】 CCRP Valid Practice Questions, CCRP Valid Exam Pdf

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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.

Free PDF SOCRA - Useful CCRP - Certified Clinical Research Professional (CCRP) Valid Practice QuestionsThe PDFVCE is one of the top-rated and renowned platforms that have been offering real and valid Certified Clinical Research Professional (CCRP) (CCRP) practice test questions for many years. During this long time period countless Certified Clinical Research Professional (CCRP) (CCRP) exam candidates have passed their dream Certified Clinical Research Professional (CCRP) (CCRP) certification exam and they are now certified SOCRA professionals and pursuing a rewarding career in the market.
SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q83-Q88):NEW QUESTION # 83
On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?
  • A. 16 May 2022
  • B. 15 May 2022
  • C. 16 May 2021
  • D. 15 May 2034
Answer: A
Explanation:
Record retention requirements ensure regulatory access to data even after development is discontinued.
* 21 CFR 312.62(c):"An investigator shall retain records... for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified."
* In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil after the 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).
Options A and B are premature; D (2034) is far beyond requirements.
Thus, the correct answer isC (16 May 2022).
References:
21 CFR 312.62(c) (Investigator record retention).
21 CFR 312.57(c) (Sponsor record retention).

NEW QUESTION # 84
In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?
  • A. A significant change in an investigator's financial interest in the investigational product
  • B. A change in the manufacturing site for the investigational product
  • C. The addition of a new test that is intended to improve monitoring the subject for an adverse effect
  • D. The addition of a sub-investigator with the scientific training and expertise to conduct the investigation
Answer: B
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 # 85
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
  • A. The audit certificate
  • B. The master randomization list
  • C. The final trial closeout monitoring report
  • D. The completed subject identification code list
Answer: D
Explanation:
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.
* ICH E6(R2) 8.3.21:"Subject Identification Code List - A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."
* ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer isB (Completed Subject Identification Code List).
References:
ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), §8.4 (Essential documents for trial closure).

NEW QUESTION # 86
A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?
  • A. After investigator documents explanation in chart
  • B. After sponsor revises eligibility and IRB approves amendment
  • C. After repeat test confirms 1.6
  • D. After monitor approves deviation
Answer: B
Explanation:
* ICH E6(R2) 4.5.1:"The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC."
* Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.
Thus, enrollment requires protocol amendment and IRB approval.
References:ICH E6(R2), §4.5.1.

NEW QUESTION # 87
During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?
  • A. IRB/IEC's procedures
  • B. Dispensing pharmacy's procedures
  • C. Regulatory authority's procedures
  • D. Sponsor's procedures
Answer: D
Explanation:
* ICH E6(R2) 5.13.3:The sponsor is responsible for the supply, storage, and final disposition of investigational product.
* 21 CFR 312.59:Sponsors must assure return or proper disposition of unused supplies.
* Sites must followsponsor's written proceduresfor reconciliation, return, or destruction, not IRB or pharmacy processes.
References:ICH E6(R2) §5.13.3; 21 CFR 312.59.

NEW QUESTION # 88
......
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