1.
Which of these is a scope the certification program is based on?
Correct Answer
A. Good clinical practice
Explanation
The correct answer is Good clinical practice. Good clinical practice refers to a set of international ethical and scientific quality standards that govern the design, conduct, recording, and reporting of clinical trials. It ensures that the rights, safety, and well-being of trial subjects are protected and that the data generated is reliable and credible. The certification program is based on these principles to ensure that individuals have the necessary knowledge and skills to conduct clinical trials in accordance with these standards.
2.
Which of these is a code that guides the clinical research?
Correct Answer
C. ICH GCP E6
Explanation
ICH GCP E6 is the correct answer because it refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guideline E6. This guideline provides a standardized framework for the design, conduct, and reporting of clinical trials. It ensures the protection of human subjects and the reliability and integrity of the data generated during clinical research.
3.
What body regulates the exam?
Correct Answer
A. SOCRA
Explanation
SOCRA stands for Society of Clinical Research Associates. It is a professional organization that promotes excellence in clinical research by providing education, training, and certification to individuals involved in the field. SOCRA does not regulate exams directly, but it does offer certification exams for clinical research professionals. Therefore, it can be inferred that SOCRA indirectly regulates the exam by setting the standards and requirements for certification in the field of clinical research.
4.
Which of these can take the CCRP exam?
Correct Answer
D. All of the above
Explanation
All of the mentioned professionals - Clinical Specialists, Data Managers, and Statisticians - are eligible to take the CCRP exam.
5.
Which of these is a way to test the exam?
Correct Answer
A. CBT
Explanation
CBT stands for Computer-Based Testing, which is a method of administering exams using a computer or electronic device. This allows for a more efficient and standardized way of testing as it eliminates the need for paper-based exams. CBT can include various question formats such as multiple-choice, fill in the blanks, and essay questions. It also allows for immediate scoring and feedback, making it a popular choice for many educational institutions and certification programs.
6.
What committee administers the exam independently?
Correct Answer
A. Certification
Explanation
The committee that administers the exam independently is the Certification committee. This committee is responsible for ensuring that the exam is conducted impartially and without any external influence. They oversee the entire process, from setting the exam questions to grading the results, to ensure that the certification process is fair and unbiased.
7.
How many years does the certification last for?
Correct Answer
A. 3
Explanation
The certification lasts for 3 years.
8.
Which of these organisations certifies the exam?
Correct Answer
B. NCCA
Explanation
The correct answer is NCCA. The NCCA, or National Commission for Certifying Agencies, is an organization that provides accreditation to certification programs. They evaluate and ensure that the certification process meets industry standards and that the certification is valid and reliable. Therefore, NCCA is the organization that certifies the exam.
9.
What does SOCRA mean?
Correct Answer
A. Society of Clinical Research Associates
Explanation
SOCRA stands for Society of Clinical Research Associates. This organization is dedicated to the advancement of clinical research professionals and promotes excellence in the field. They provide education, training, and certification opportunities for individuals involved in clinical research. By choosing the correct answer, it shows an understanding of the acronym and its significance within the clinical research community.
10.
Which of the following options does the certification not require one to be?
Correct Answer
D. Studentship
Explanation
The certification does not require one to be a student. It may require membership, education, and work experience, but studentship is not a requirement.