CRA Interview Exam REAL QUESTIONS AND VERIFIED ANSWERS |100% CORRECT |
ALREADY GRADED a+| pass!!!
The research team actively maintains informed consent throughout the entire trial by
providing the participant with any new or developing information, as needed.
Who Can Participate In A Clinical Trial? -answer-Before joining a clinical trial, a
participant must meet certain criteria. This is an important aspect of any clinical trial to
ensure that the treatment is being investigated accurately and safely. Factors that allow
someone to participate in a clinical trial are called "inclusion criteria," and those that
disallow someone from participating are called "exclusion criteria."
These criteria are used to identify appropriate participants. Acceptance of a participant
into a clinical trial is based on such factors as age, gender, the type and stage of
disease, previous treatment history, and other medical conditions.
For example, some research studies seek participants with specific illnesses or
conditions, while others need healthy participants. Some studies may include only men,
some studies may include men and women but not women of child-bearing potential,
and some studies may include men and women within a specific age range (ie, 18-65
years of age). These criteria are defined by the amount of scientific and safety
information that is known about a treatment being tested at the time the trial is planned
to start.
What Is A Protocol? -answer-A protocol is the study plan on which the clinical trial is
based. Each trial is carefully designed to safeguard the health of participants as well as
answer specific research questions. The protocol describes in detail what types of
people may participate in the trial, the schedule of tests, procedures, medications,
dosages, and length of the study.
What Is A Placebo? -answer-A placebo is an inactive pill, liquid or powder that has no
treatment value. In a placebo controlled trial, some portion of the participants will
,receive placebo instead of an active drug or experimental treatment to assess the
experimental treatment's effectiveness and safety relative to no treatment at all.
What Is A Control Or Control Group? -answer-A control is the standard by which
experimental observations are evaluated. In many clinical trials, one group of patients
will be given an experimental drug or treatment, while the control group is given either a
standard treatment for the illness or a placebo.
What Are The Phases Of Clinical Trials? -answer-Clinical trials are conducted in a
series of stages, called phases, each having specific goals. This process provides
information about the treatment in a controlled process intended to also protect the
participants. The number of participants in each phase of the trial may be based on the
overall incidence of the condition being studied.
Clinical trials are usually classified into one of four phases:
Phase 1: Sometimes called dosing, pharmacokinetic, or clinical pharmacology studies,
these trials test methods of administering the treatment (e.g. by mouth, injection, etc.)
and how often, as well as the safety of the treatment. These trials usually involve a
small number of healthy participants (20-80 healthy volunteers).
Phase 2: These trials continue to test the safety of the treatment and evaluate how well
the treatment is tolerated and how well it works. Phase II studies usually evaluate the
treatment in a specific condition. These trials usually involve 100-300 patients.
Phase 3: These trials compare the experimental treatment to the current standard of
treatment for a specific condition, establishing both efficacy and adverse events.
Participants are usually assigned to either receive the experimental treatment or the
current standard. Phase III trials typically enroll large numbers of patients (1,000-3,000)
and may be carried out at hospitals and doctors' offices nationwide.
Phase 4: Post-marketing studies to gain a greater understanding of the treatment,
including its risks, benefits, and optimal use. Depending on the purpose of these studies
they may be small studies like the Phase I type OR may be even larger than a Phase III
study.
What Is A Prospective, Randomized, Double-blind, Controlled Clinical Trial? -answer-A
prospective, randomized, double-blind, controlled clinical trial is the most rigorous
clinical trial design, and the one that regulatory agencies mandate must be conducted to
demonstrate a medication's effectiveness and safety. In a new drug application, these
studies represent the highest quality data regarding the drug and its actions, and form
the basis for approval. In this study design, patients are carefully selected for
participation and are randomly assigned to receive the experimental drug or a matching
active drug or placebo. Neither the patient nor the treating physician knows which
treatment was provided, thereby eliminating possible bias.
Individual definitions of the study descriptions are:
, Prospective: Forward looking, beginning before the patient has started treatment.
Randomized: Patients are randomly assigned to receive the experimental treatment or
alternative (e.g. standard of care or placebo)
Double-blind: Neither patients nor the study staff knows which participants are receiving
the experimental drug and which are receiving a placebo or standard treatment.
Controlled: One group of patients will be given an experimental drug or treatment, while
a second group is given either a standard treatment for the illness or a placebo.
What Are Side Effects And Adverse Reactions? -answer-Side effects include any
undesired actions or effects of a drug or treatment.
Experimental drugs must be evaluated for both immediate and long-term side effects.
Can A Participant Leave A Clinical Trial At Any Point? -answer-A participant can leave
a clinical trial at any time. The participant should let the research team know when
withdrawing from the trial and the reasons for leaving the study.
Who Sponsors A Clinical Trial? -answer-Clinical trials can be sponsored or funded by a
variety of organizations or individuals including physicians, medical institutions,
foundations, voluntary groups, and pharmaceutical companies, in addition to
government agencies such as the National Institutes of Health (NIH), the Department of
Defense (DOD), Human Health and Services (HHS), and the Department of Veteran's
Affairs (VA).
Are you familiar with what 'expanded access' means? -answer-Expanded access is the
term used to describe the means by which manufacturers make new drugs that are
being investigated available, under certain circumstances, to treat a patient(s) with a
serious disease or condition who cannot participate in a controlled clinical trial. If you
have experience working with patients who have been given expanded access, share
some details, as appropriate. If you don't have personal experience, share your
knowledge.
I do have some knowledge about 'expanded access' although I have not worked directly
with patients who have been giveThe manufacturer must be willing to make the drug
available for expanded access use. The primary intent of expanded access is to provide
treatment for a patient's disease or condition, rather than to collect data about the study
drug.
Are you familiar with what a protocol is with regard to clinical research? -answer-A
protocol is the plan that the clinical trial is based upon. It describes the details regarding
what people may participate in the trial as well as tests, medications, and length of the
study.
ALREADY GRADED a+| pass!!!
The research team actively maintains informed consent throughout the entire trial by
providing the participant with any new or developing information, as needed.
Who Can Participate In A Clinical Trial? -answer-Before joining a clinical trial, a
participant must meet certain criteria. This is an important aspect of any clinical trial to
ensure that the treatment is being investigated accurately and safely. Factors that allow
someone to participate in a clinical trial are called "inclusion criteria," and those that
disallow someone from participating are called "exclusion criteria."
These criteria are used to identify appropriate participants. Acceptance of a participant
into a clinical trial is based on such factors as age, gender, the type and stage of
disease, previous treatment history, and other medical conditions.
For example, some research studies seek participants with specific illnesses or
conditions, while others need healthy participants. Some studies may include only men,
some studies may include men and women but not women of child-bearing potential,
and some studies may include men and women within a specific age range (ie, 18-65
years of age). These criteria are defined by the amount of scientific and safety
information that is known about a treatment being tested at the time the trial is planned
to start.
What Is A Protocol? -answer-A protocol is the study plan on which the clinical trial is
based. Each trial is carefully designed to safeguard the health of participants as well as
answer specific research questions. The protocol describes in detail what types of
people may participate in the trial, the schedule of tests, procedures, medications,
dosages, and length of the study.
What Is A Placebo? -answer-A placebo is an inactive pill, liquid or powder that has no
treatment value. In a placebo controlled trial, some portion of the participants will
,receive placebo instead of an active drug or experimental treatment to assess the
experimental treatment's effectiveness and safety relative to no treatment at all.
What Is A Control Or Control Group? -answer-A control is the standard by which
experimental observations are evaluated. In many clinical trials, one group of patients
will be given an experimental drug or treatment, while the control group is given either a
standard treatment for the illness or a placebo.
What Are The Phases Of Clinical Trials? -answer-Clinical trials are conducted in a
series of stages, called phases, each having specific goals. This process provides
information about the treatment in a controlled process intended to also protect the
participants. The number of participants in each phase of the trial may be based on the
overall incidence of the condition being studied.
Clinical trials are usually classified into one of four phases:
Phase 1: Sometimes called dosing, pharmacokinetic, or clinical pharmacology studies,
these trials test methods of administering the treatment (e.g. by mouth, injection, etc.)
and how often, as well as the safety of the treatment. These trials usually involve a
small number of healthy participants (20-80 healthy volunteers).
Phase 2: These trials continue to test the safety of the treatment and evaluate how well
the treatment is tolerated and how well it works. Phase II studies usually evaluate the
treatment in a specific condition. These trials usually involve 100-300 patients.
Phase 3: These trials compare the experimental treatment to the current standard of
treatment for a specific condition, establishing both efficacy and adverse events.
Participants are usually assigned to either receive the experimental treatment or the
current standard. Phase III trials typically enroll large numbers of patients (1,000-3,000)
and may be carried out at hospitals and doctors' offices nationwide.
Phase 4: Post-marketing studies to gain a greater understanding of the treatment,
including its risks, benefits, and optimal use. Depending on the purpose of these studies
they may be small studies like the Phase I type OR may be even larger than a Phase III
study.
What Is A Prospective, Randomized, Double-blind, Controlled Clinical Trial? -answer-A
prospective, randomized, double-blind, controlled clinical trial is the most rigorous
clinical trial design, and the one that regulatory agencies mandate must be conducted to
demonstrate a medication's effectiveness and safety. In a new drug application, these
studies represent the highest quality data regarding the drug and its actions, and form
the basis for approval. In this study design, patients are carefully selected for
participation and are randomly assigned to receive the experimental drug or a matching
active drug or placebo. Neither the patient nor the treating physician knows which
treatment was provided, thereby eliminating possible bias.
Individual definitions of the study descriptions are:
, Prospective: Forward looking, beginning before the patient has started treatment.
Randomized: Patients are randomly assigned to receive the experimental treatment or
alternative (e.g. standard of care or placebo)
Double-blind: Neither patients nor the study staff knows which participants are receiving
the experimental drug and which are receiving a placebo or standard treatment.
Controlled: One group of patients will be given an experimental drug or treatment, while
a second group is given either a standard treatment for the illness or a placebo.
What Are Side Effects And Adverse Reactions? -answer-Side effects include any
undesired actions or effects of a drug or treatment.
Experimental drugs must be evaluated for both immediate and long-term side effects.
Can A Participant Leave A Clinical Trial At Any Point? -answer-A participant can leave
a clinical trial at any time. The participant should let the research team know when
withdrawing from the trial and the reasons for leaving the study.
Who Sponsors A Clinical Trial? -answer-Clinical trials can be sponsored or funded by a
variety of organizations or individuals including physicians, medical institutions,
foundations, voluntary groups, and pharmaceutical companies, in addition to
government agencies such as the National Institutes of Health (NIH), the Department of
Defense (DOD), Human Health and Services (HHS), and the Department of Veteran's
Affairs (VA).
Are you familiar with what 'expanded access' means? -answer-Expanded access is the
term used to describe the means by which manufacturers make new drugs that are
being investigated available, under certain circumstances, to treat a patient(s) with a
serious disease or condition who cannot participate in a controlled clinical trial. If you
have experience working with patients who have been given expanded access, share
some details, as appropriate. If you don't have personal experience, share your
knowledge.
I do have some knowledge about 'expanded access' although I have not worked directly
with patients who have been giveThe manufacturer must be willing to make the drug
available for expanded access use. The primary intent of expanded access is to provide
treatment for a patient's disease or condition, rather than to collect data about the study
drug.
Are you familiar with what a protocol is with regard to clinical research? -answer-A
protocol is the plan that the clinical trial is based upon. It describes the details regarding
what people may participate in the trial as well as tests, medications, and length of the
study.
