1.
What is the job growth in terms of percentage of a clinical laboratory technologist?
Correct Answer
B. 14%
Explanation
The correct answer is 14%. This means that the job growth for clinical laboratory technologists is projected to increase by 14% in the future. This indicates a positive outlook for employment opportunities in this field.
2.
What do you call trained medical scientist that take care of the planning, coordination and management of clinical trials?
Correct Answer
C. Clinical Research Coordinator
Explanation
A Clinical Research Coordinator is a trained medical scientist who is responsible for the planning, coordination, and management of clinical trials. They play a crucial role in ensuring that the trials are conducted safely and efficiently. They work closely with doctors and physicians to ensure that the trials are conducted according to strict protocols and ethical standards. Their primary responsibilities include recruiting and screening participants, collecting and analyzing data, and ensuring compliance with regulatory requirements. Therefore, the answer "Clinical Research Coordinator" is the correct choice for this question.
3.
What other duty does a CRC have aside planning and coordination of clinical trials?
Correct Answer
A. Records and analyze the progress of research as it is collected
Explanation
A CRC, or Clinical Research Coordinator, has the duty of recording and analyzing the progress of research as it is collected. This involves keeping track of data and information gathered during the clinical trials and analyzing it to assess the effectiveness and safety of the treatment being tested. By doing so, the CRC plays a crucial role in ensuring the accuracy and integrity of the research process, as well as providing valuable insights for the development of new treatments or interventions.
4.
When was declaration of Helsinki introduced?
Correct Answer
B. 1964
Explanation
The correct answer is 1964. The Declaration of Helsinki is a set of ethical principles regarding human experimentation in medical research. It was first introduced in 1964 by the World Medical Association and has been revised several times since then. This declaration provides guidelines for researchers to ensure the protection and well-being of human subjects involved in medical research.
5.
What is one who submits the marketing application to the FDA for approval of a device, drug or biologic product called?
Correct Answer
B. Applicant
Explanation
The correct answer is "Applicant." An applicant is the person or organization who submits the marketing application to the FDA for approval of a device, drug, or biologic product. They are responsible for providing all the necessary information and documentation required for the FDA's review and evaluation process.
6.
Who else In addition to the FDA, recommends the use of SOPs?
Correct Answer
C. The International Conference on Harmonization
Explanation
The International Conference on Harmonization (ICH) is a global organization that brings together regulatory authorities and the pharmaceutical industry to develop and promote international standards for the registration, safety, and efficacy of pharmaceutical products. They recommend the use of Standard Operating Procedures (SOPs) as a best practice for ensuring consistency and quality in the development, manufacturing, and distribution of pharmaceutical products.
7.
What is the code of disposition of unused study drug?
Correct Answer
A. 312.59
Explanation
The code 312.59 is the correct answer for the disposition of unused study drug. This code is used in medical coding to classify the specific condition or circumstance related to the unused study drug. It represents a specific category or subcategory within the coding system that healthcare professionals use to accurately document and track information related to patient care and treatment.
8.
Determinations for INDs should be made by the FDA within how many days of application?
Correct Answer
A. 30 or less
Explanation
The FDA should make determinations for Investigational New Drug (IND) applications within 30 days or less. This means that the FDA should review and decide on whether to approve or deny an IND application within this timeframe. This is important as it allows for the timely evaluation and potential authorization of new drugs for use in clinical trials, ensuring that the process is efficient and does not cause unnecessary delays in the development of new treatments.
9.
What's the minimum number of IRB members?
Correct Answer
A. 5
Explanation
The minimum number of IRB members is 5 because IRB (Institutional Review Board) is a committee that reviews research proposals to ensure the protection of human subjects. It is important to have a diverse group of members with different expertise and perspectives to effectively review research proposals. Having a minimum of 5 members allows for a more comprehensive evaluation of the ethical implications of the research, ensuring the safety and welfare of the participants.
10.
Which of these deals with IRBs and their standards that they must adhere to?
Correct Answer
C. 21CFR56
Explanation
21CFR56 deals with IRBs (Institutional Review Boards) and their standards that they must adhere to. IRBs are responsible for reviewing and approving research studies involving human subjects to ensure the protection of their rights and welfare. 21CFR56 outlines the regulations and guidelines that IRBs must follow, including the composition of the board, the review process, informed consent requirements, and ongoing monitoring of approved studies. This regulation helps to ensure ethical conduct and the safety of participants in research studies.