CRS ACTUAL EXAM 3 QUESTIONS WITH ANSWERS
2025/2026 GRADED A+
What does the Project Manager do? - defines goals and requirements for clinical trials
and helps to ensure they are met
What does the CRO do? - assumes, as an independent contractor with the sponsor,
one or more of the obligations of the sponsor
CDER regulates - OTC and prescription drugs, including biological therapeutics and
generic drugs
CDRH regulates - assures that patients and providers have timely and continued
access to safe, effective, and high quality medical devices and safe emitting products
CBER regulates - biological products for human use under applicable federal laws
Who is responsible for selecting qualified monitors? - the sponsor of a clinical trial
What is the purpose of clinical trial monitoring? - ensure subject protections
ensure reliable data
ensure compliance
Which of the following occurs at the site qualification visit? - an assessment of the PI
and the study staff's experiences and ability to conduct research
The best recommendation for a potential investigator in a Phase III diabetic clinical trial
is a physician who has: - Applied for board certification in endocrinology
Received an inspection report 5 years ago citing missing SOPs
Select all of the following questions a CRA should ask during a qualification visit - Are
there any other studies at the site?
Has the PI done any previous studies in the therapeutic area?
Does the investigator have research experience?
Were previous enrollment study targets met?
A PI that has no research experience is not qualified for a clinical research study - False
How does the clinical trial monitor ensure compliance with FDA mandated regulation for
the control of an investigational product? - Be ensuring that a site is properly trained on
the storage and maintenance of the investigational product
Since the facilities and laboratory equipment are checked during qualifications, the CRA
does not need to recheck them at the initiation visit unless the sponsor specifically
requests it - False
, What term best describes the act of knowingly, willfully, and repeatedly making false
statements or submitting false information with the intent to deceive? - Fraud
With which of the following documents should a qualified monitor be familiar? - Written
informed consent form to be used to consent subjects for a trial they are monitoring
Which type of monitoring is best described as remote evaluation of accumulating data,
performed in a timely manner, supported by appropriately qualified and trained
persons? - Centralized monitoring
The CRA calls the site to confirm the COV date, but the CRC says "the PI will be out of
town that day but most of the trial files should be available for the visit." what should the
CRA do? - Reschedule the visit for a day when all the files and the PI are available
Which of the following are responsibilities of the monitor? - Verifying that investigators
are following the approved protocol
Checking the accuracy and completeness of CRF entries
Verifying that written informed consent was obtained before each subjects participation
in the trial
When should the study COV be conducted? - Once all subjects have discontinued use
of the IP
Is it unethical to conduct research in children? - False
You are a pediatrician conducting a clinical trial in your office. Your first patient arrives,
and you evaluate him for eligibility in your clinical trial. Which of the following will you
need to consider? - Who is the legally authorized representative for consent?
Do the benefits to the child outweigh the risks?
Is there sufficient time to review the proposed research with the subject and his
parents?
Is consent of the patient required?
Which of the following laws outlines US regulatory requirement for the protection of
human subject and vulnerable populations involved in federally funded research? - Title
45 part 46
What is the most important factor to consider when conducting research in human
subjects? - The rights, safety, and well-being of the trial subjects are protected
In conducting ethical clinical research, which of the following is MOST important to do
when using human research subjects? - Ensuring publications of results regardless of
outcomes
obtaining proper informed consent
avoiding any potential financial conflicts of interest
conducting a scientifically sound research trial
2025/2026 GRADED A+
What does the Project Manager do? - defines goals and requirements for clinical trials
and helps to ensure they are met
What does the CRO do? - assumes, as an independent contractor with the sponsor,
one or more of the obligations of the sponsor
CDER regulates - OTC and prescription drugs, including biological therapeutics and
generic drugs
CDRH regulates - assures that patients and providers have timely and continued
access to safe, effective, and high quality medical devices and safe emitting products
CBER regulates - biological products for human use under applicable federal laws
Who is responsible for selecting qualified monitors? - the sponsor of a clinical trial
What is the purpose of clinical trial monitoring? - ensure subject protections
ensure reliable data
ensure compliance
Which of the following occurs at the site qualification visit? - an assessment of the PI
and the study staff's experiences and ability to conduct research
The best recommendation for a potential investigator in a Phase III diabetic clinical trial
is a physician who has: - Applied for board certification in endocrinology
Received an inspection report 5 years ago citing missing SOPs
Select all of the following questions a CRA should ask during a qualification visit - Are
there any other studies at the site?
Has the PI done any previous studies in the therapeutic area?
Does the investigator have research experience?
Were previous enrollment study targets met?
A PI that has no research experience is not qualified for a clinical research study - False
How does the clinical trial monitor ensure compliance with FDA mandated regulation for
the control of an investigational product? - Be ensuring that a site is properly trained on
the storage and maintenance of the investigational product
Since the facilities and laboratory equipment are checked during qualifications, the CRA
does not need to recheck them at the initiation visit unless the sponsor specifically
requests it - False
, What term best describes the act of knowingly, willfully, and repeatedly making false
statements or submitting false information with the intent to deceive? - Fraud
With which of the following documents should a qualified monitor be familiar? - Written
informed consent form to be used to consent subjects for a trial they are monitoring
Which type of monitoring is best described as remote evaluation of accumulating data,
performed in a timely manner, supported by appropriately qualified and trained
persons? - Centralized monitoring
The CRA calls the site to confirm the COV date, but the CRC says "the PI will be out of
town that day but most of the trial files should be available for the visit." what should the
CRA do? - Reschedule the visit for a day when all the files and the PI are available
Which of the following are responsibilities of the monitor? - Verifying that investigators
are following the approved protocol
Checking the accuracy and completeness of CRF entries
Verifying that written informed consent was obtained before each subjects participation
in the trial
When should the study COV be conducted? - Once all subjects have discontinued use
of the IP
Is it unethical to conduct research in children? - False
You are a pediatrician conducting a clinical trial in your office. Your first patient arrives,
and you evaluate him for eligibility in your clinical trial. Which of the following will you
need to consider? - Who is the legally authorized representative for consent?
Do the benefits to the child outweigh the risks?
Is there sufficient time to review the proposed research with the subject and his
parents?
Is consent of the patient required?
Which of the following laws outlines US regulatory requirement for the protection of
human subject and vulnerable populations involved in federally funded research? - Title
45 part 46
What is the most important factor to consider when conducting research in human
subjects? - The rights, safety, and well-being of the trial subjects are protected
In conducting ethical clinical research, which of the following is MOST important to do
when using human research subjects? - Ensuring publications of results regardless of
outcomes
obtaining proper informed consent
avoiding any potential financial conflicts of interest
conducting a scientifically sound research trial
