Open the auxiliary access

Firefly Open Source Community

   Login   |   Register   |
New_Topic
Firefly Open Source Community › Embedded Board › ROC-RK3328-PC› 2026 Pass-Sure CCRP: New Certified Clinical Research ...
New Topic
Print Previous Topic Next Topic

[General] 2026 Pass-Sure CCRP: New Certified Clinical Research Professional (CCRP) Exam La

chriski432

140

Credits

0

Prestige

0

Contribution

registered members

Rank: 2

Credits
140

【General】 2026 Pass-Sure CCRP: New Certified Clinical Research Professional (CCRP) Exam La

Posted at 9 hour before      View：15 | Replies：0        Print      Only Author   [Copy Link] 1#
DOWNLOAD the newest Prep4away CCRP PDF dumps from Cloud Storage for free: https://drive.google.com/open?id=1e4XERyOJKmzFQ1VqXO3Hpq5DAXp606_7
Customizable practice tests comprehensively and accurately represent the actual Professional SOCRA CCRP Certification Exam pattern. Many students have studied from product and passed the Certified Clinical Research Professional (CCRP) (CCRP) test with ease. Our customers can receive questions updates for up to 1 year after purchasing the product. These free updates of questions will help them to prepare according to the latest syllabus.
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.

CCRP Guide Questions - CCRP Test Torrent & CCRP Exam TorrentIt is a truth universally acknowledged that the exam is not easy but the related CCRP certification is of great significance for workers in this field so that many workers have to meet the challenge, I am glad to tell you that our company aims to help you to pass the examination as well as gaining the related certification in a more efficient and simpler way. During recent 10 years, our CCRP Exam Questions have met with warm reception and quick sale in the international market. Our CCRP study materials are not only as reasonable priced as other makers, but also they are distinctly superior in the following respects.
SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q130-Q135):NEW QUESTION # 130
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?
  • A. Sponsor
  • B. Clinical investigator
  • C. IRB/IEC
  • D. Program manager
Answer: B
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 # 131
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
  • A. Within 15 working days
  • B. Within 10 working days
  • C. Within 7 working days
  • D. Immediately
Answer: D
Explanation:
ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:
* ICH E6(R2) 4.11.1: "The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol... identifies as not needing immediate reporting." Therefore, "Immediately" (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.
References:
ICH E6(R2) Good Clinical Practice, §4.11.1 (Safety reporting by investigators).===========

NEW QUESTION # 132
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
  • A. The FDA may inspect them only if the IRB/IEC formally requests inspection
  • B. The FDA may inspect them at reasonable times, in a reasonable manner, but may not take copies unless requested with an affidavit
  • C. The FDA does not have regulatory authority to inspect them
  • D. The FDA may inspect them at reasonable times, in a reasonable manner, and may take copies of IRB
    /IEC records
Answer: D
Explanation:
The FDA has full regulatory authority to inspect IRB/IEC records.
* 21 CFR 56.115(b):"The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained... at reasonable times and in a reasonable manner." Thus, FDA mayinspect and copyIRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.
Incorrect options:
* (A) limits authority incorrectly.
* (C) is false - FDA explicitly regulates IRBs.
* (D) is false - FDA does not need IRB invitation.
Correct answer:B.
References:
21 CFR 56.115(b).

NEW QUESTION # 133
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 sub-investigator with the scientific training and expertise to conduct the investigation
  • D. The addition of a new test that is intended to improve monitoring the subject for an adverse effect
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 # 134
Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?
  • A. Dignity
  • B. Beneficence
  • C. Justice
  • D. Respect for Persons
Answer: D
Explanation:
* Belmont Report:"Respect for Persons" incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).
* Prisoners require special safeguards because of restricted liberty and potential coercion.
References:Belmont Report (1979).

NEW QUESTION # 135
......
There are three different versions of our SOCRA CCRP preparation prep including PDF, App and PC version. Each version has the suitable place and device for customers to learn anytime, anywhere. In order to give you a basic understanding of our various versions on our Certified Clinical Research Professional (CCRP) CCRP Exam Questions, each version offers a free trial.
CCRP Valid Practice Questions: https://www.prep4away.com/SOCRA-certification/braindumps.CCRP.ete.file.html
P.S. Free & New CCRP dumps are available on Google Drive shared by Prep4away: https://drive.google.com/open?id=1e4XERyOJKmzFQ1VqXO3Hpq5DAXp606_7
https://www.torrentexam.com
Reply

Use props Report

Return to List
High mode
B Color Image Link Quote Code Smilies
You need to log in before you can reply Login | Register

This forum Credits Rules

  •  

Service Hotline : (+86)18688117175
Contact us
E-mail : global@t-firefly.com
Copyright © 2014-2022, FIREFLY TECHNOLOGY CO.,LTD. All Rightts Reserved. 粤ICP备14022046号-2
Quick Reply Back to top Back to list