How much do you know about Early Phase Clinical Trials (i.e. Phase I and II Trials?)
During which of these clinical research phases is a drug's safety tested by increasing the dose to establish which doses are safe and well tolerated?
Phase I
The description of ____should be clear, balanced, and based on reliable information to the extent such information is available.
Benefits
Explanation
This means that when explaining the benefits of something, it is important to provide a clear and unbiased view, using reliable and trustworthy information as much as possible. This ensures that the information provided is accurate and helpful for the audience.
People with chronic conditions like diabetes or lung disease are at ______ risk for more severe illness if they get the COVID19 virus itself.
– A. No risk
– B. Much lower risk
– C. Much higher
C. Much higher
Info: Serious heart conditions, chronic kidney disease, cancer, sickle cell disease, Type 2 diabetes, lung disease, current or former smokers, and having an immunocompromised state all make it more likely for someone to get severely ill from COVID19.
Q: What are the documents mandatory to enroll in a clinical research study?
(A) Informed Consent Form
(B) Medical Records
(C) 1572
(D) IB
(A) Informed Consent Form
What are the most common eligibility guidelines for inclusion and exclusion criteria?
Age, Gender, type and stage of an illness, treatment history and other medical conditions
Before testing on human-beings, drug developers (or sponsors) must submit an application to the regulatory authorities, the Food and Drug Administration (FDA) Which of these details must be included in the application?
_________ participation requires that subjects be informed that they may decline to take part in the clinical investigation or may stop participation at any time without penalty or loss of benefits to which subjects are entitled.
Voluntary
Explanation
Voluntary participation refers to the ethical principle that individuals have the right to choose whether to participate in a clinical investigation. This principle ensures that subjects are fully informed about the study and have the freedom to decline participation or withdraw from the study at any time without facing any negative consequences or losing any benefits they are entitled to. It emphasizes the importance of respecting individual autonomy and protecting the rights and well-being of research participants.
The COVID19 vaccine contains: –
(A) The virus
(B) Pork and pork products.
(C) Microchips – D. A, B & C
(E) None of the above
E. None of the above
Info: The vaccine does not have pork, animal products, microchips, fetal cells or a live virus. It does not give you COVID19 or change your DNA.
Who is responsible for preparing essential documents like protocol/ investigators brochure/ informed consent form/ case report form during clinical trials?
Investigator
What are the main topics a study team should discuss with a subject before enrolling a subject for clinical trial?
- The study purpose and duration
- The possible risks and benefits
- Participation and care
- Personal and Cost concerns
Approximately how many years of research/development/testing does it take to get a drug approved for marketing?
12 Years
True/False: For all FDA-regulated clinical investigations (except as provided in 21 CFR 50.23 and 50.245), legally effective informed consent must be obtained from the subject or the subject's legally authorized representative.
True
Explanation
The statement is true because according to FDA regulations, informed consent must be obtained from the subject or their legally authorized representative for all FDA-regulated clinical investigations, except in specific situations outlined in 21 CFR 50.23 and 50.245. This ensures that individuals participating in clinical trials are fully informed about the purpose, risks, and benefits of the study, and have the autonomy to make an informed decision about their participation.
Which brand requires only one shot to be vaccinated?
Info: J&J requires only one dose. Pfizer/Comirnaty and Moderna require a second dose 3 or 4 weeks and up to 6 weeks after the first dose.
The assignment of treatment to participants in a way such that participants and, sometimes, providers do not know the actual treatment allocation.
Blinding
How is subject safety protected?
(A) Inform Consent Form, IRB regulations
(B) Reviewing AEs and SAEs, SUSARs
(C) CVs and 1572
(D) Good Clinical Practice and FDA
(E) A and D
(F) ALL of the above
(E) A and D
On average, how long does it take for the Food and Drug Administration to review data submitted in a standard New Drug Application (NDA) after the drug has been tested on humans in clinical trials?
10 months
____is not a basic element of informed consent.
(A) Subject age.
(B) IP participation.
(C) Number of participations.
(C) Number of participation
Explanation
Informed consent is a process in which individuals are provided with information about a clinical investigation and voluntarily agree to participate. The basic elements of informed consent include a description of the clinical investigation, voluntary participation, and contacts for further information. The number of participation is not considered a basic element of informed consent as it does not directly relate to the individual's understanding of the study or their ability to make an informed decision about participating.
Like other vaccines, the COVID19 vaccine teaches our bodies how to ____ and _____ the coronavirus that causes COVID19.
A. Create/Grow.
B. Recognize/Increase.
C. Recognize/Fight.
C. Recognize/Fight
Info: The vaccines teach your body to make a harmless protein that looks like the protein in the COVID19 virus. Your body responds to the protein and creates disease-fighting cells and antibodies that can recognize and fight the COVID19 virus.
A biologically inert substance that is identical in appearance to the treatment under investigation is ______.
Placebo
When weighing the risk of a subject in a clinical trial, what needs to be considered?
- Likelihood of potential risk and benefits
True or False — Only people with a health condition are eligible to participate in clinical trials.
False.
What is the difference between Informed Consent, and the process of obtaining Assent and Parental Permission?
Because children and some adults with impaired consent capacity are not legally considered capable of providing consent, regulations do allow a parent or legally authorized representative (LAR) to give “permission” for the individual to participate when assent or “affirmatively agreement” to participate is obtained from the child (or adult with impaired consent capacity). Depending on the risk level of the study, provisions may be necessary for permission of both parents.
Whether vaccinated or unvaccinated, everyone should practice:
(A) Staying inside during the day
(B) Washing hands, wearing masks, and physical distancing
(C) Continue as normal because the pandemic has ended
(B) Washing hands, wearing masks, and physical distancing
Info: The Delta variant is highly contagious. Some data suggests that the Delta variant may cause more severe illness among unvaccinated people.
Fully vaccinated people with a breakthrough infection caused by the Delta variant can spread the virus to others, but for a shorter amount of time than unvaccinated people.
An observational study in which subjects are sampled based on the presence of absence of a risk factor of interest; these subjects are followed over time and observed for the development of a disease or outcome of interest.
Cohort Study
What are the red flags a CRA should look for during a MV to confirm Subject in-eligibility?
Age, gender, medical history, and current health status