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crm exam 2

Terms in this set (76)

What should be used to determine the extent and nature of monitoring?
The purpose, complexity, and endpoints of the study
True or False: The clinical trial monitor must ensure that they are informing the FDA of any CRF entry error they find during the course of clinical trial monitoring.
False
What should be included on the monitoring visit report?
Name of the Principal Investigator at the site
Why has the FDA has encouraged sponsors to adopt a risk-based approach to clinical trial monitoring?
FDA believes that risk-based monitoring will improve sponsor oversight of clinical trials.
Which activity does FDA believe can be done better through the use of remote monitoring?
Analyzing site performance metrics, and clinical data to identify trial sites that have poor performance or potential noncompliance
What should the sponsor consider during the identification of critical data process?
The quantity and type of source data that needs to be verified
When the sponsor is identifying critical data to determine the best approach to monitoring, which of the following would be considered critical?
Verification of informed consent
What is the next step the sponsor should take after identifying critical data and processes?
Conduct a risk assessment to identify potential risks that may affect the collection of critical data
If the sponsor of a clinical trial is planning on delegating the task of monitoring the clinical trial to a Contract Research Organization, what do FDA regulations require that they do?
Have a written transfer of obligations from the sponsor to the CRO
True or False: Adverse drug reactions which are serious and expected must be reported promptly to the IRB by the investigator.
False
For how long should the IRB/IEC retain all relevant records?
For at least 3 years after completion of the trial
What would be an appropriate IRB/IEC roster at a Helping Hands Hospital (a fictional institution)?
A physician from the neurology department, a first grade teacher, two nurses from the emergency department, and a private practice cardiologist
What is true regarding payments to subjects?
The IRB must review the method of payment
Payments must be prorated
The IRB must review the amount of payment
Payments must be set forth in the informed consent form
How often must the IRB conduct continuing review of each ongoing trial?
At least once per year
What are the most important considerations to be taken in clinical trials?
Rights of the subject
Well-being of the subject
Safety of the subject
This person is always responsible for the medical care given to, and the medical decisions made on behalf of, subjects.
A qualified physician
Why does Dr. Beecher state that he is calling attention to ethical errors through his article?
Growing emphasis that experimentation in humans must come before applying new procedures in therapy

Increase in available research funds

Pressures on young physicians to prove themselves as investigators

Requirements and resources are greater than supply of responsible investigators
Dr. Beecher cites a 1964 study of 100 human studies published in a reputable journal - of these studies, how many seemed to be unethical?
12
"A far more dependable safeguard than consent is the presence of a truly __________ investigator."
responsible
What accounts for most of the unethical cases encountered in Dr. Beecher's study?
Thoughtlessness and carelessness
What disease did Dr. Saul Krugman study at Willowbrook State School?
Hepatitis
What was the hypothesis of the Willowbrook study?
Infection of children with a mild form of hepatitis could be an effective strategy to confer long-lasting immunity.
The Willowbrook Hepatitis Study was ethical because the form of the disease was very mild and the students were given favorable circumstances should they be infected, such as special medical and nursing personnel to provide close observation and extra care.
False
Which of these is NOT a criticism of the Willowbrook Hepatitis Study?
Dr. Krugman did not make any ethical considerations prior to the study beginning and the work had no scientific value.
What was wrong Willowbrook Hepatitis study?
Subjects in this study are from a vulnerable population

Investigators violated some of the principles outlined in the Declaration of Helsinki

The benefits of this study did not outweigh the risks
Typhoid Fever/Chloramphenicol study where some subjects were given symptomatic treatment only.
Known Effective Treatment Withheld
Study of cyclopropane anesthesia and cardiac arrhythmias where CO2 was injected into subject's respiratory systems until cardiac arrhythmias appeared.
Physiologic Studies
Live cancer cells were injected into 22 human subjects as part of a study of immunity to cancer.
Studies to Improve the Understanding of Disease
Study of effect of exercise on the cardiac output and pulmonary-artery pressure in healthy patients and patients with severe cardiac diseases with no therapeutic benefit.
Technical Study of Disease
Which individual is always 100% responsible for the conduct of a clinical trial at the site?
Principal Investigator
Coordinator:
Assists the PI in implementing research protocols at the clinical cite
Sub-Investigator:
Team member designated by the PI to perform critical trial-related procedures and make decisions
PI:
Responsible for ensuring resources and staff are available and qualified
Clinical Research Associate:
Serves as a liaison between the sponsor and the site
Project Manager:
Defines goals and requirements for clinical trials and helps to ensure that they...
Contract Research Organization:
Assumes, as an independent contractor with the sponsor, one or more of the...
Site and sponsor required to maintain clinical trial records:
2 years after last marketing action
IRB required to maintain clinical trial records:
3 years after study completion
CDER
regulates over the counter and prescription drugs
CDRH
assures to safe, effective, and high-quality medical devices and radiation-...
CBER
regulates biological products for human use under applicable federal laws
risk-based monitoring?
Monitoring approach to each individual trial based on risk assessment to identify potential issues
Who is responsible for selecting qualified monitors?
the sponsor
What is the purpose of clinical trial monitoring?
Ensure subject protections, ensure reliable data, and ensure compliance
What occurs at the site qualification visit?
An assessment of the PI and study staff's experience and ability to conduct research
The best recommendations for a potential investigator in a Phase III diabetic clinical trial is a physician who has:
Applied for board certification in endocrinology
but Received an inspection report 5 years ago citing Missing SOPs

over a limited patient base or little time for clinical trials
questions a CRA should ask during a qualification visit:
Were previous enrollment study targets met?
Has the PI done any previous studies in the therapeutic area?
Are there any other studies at the site?
Does the investigator have research experience?
A PI has no research experience is not qualified for a clinical research study
False
What is the main goal of the site initiation visit?
To clarify applicable regulations and trial requirements with site personnel
How does the clinical trial monitor ensure compliance with FDA mandated regulation for the control of an investigational product?
By 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 qualification, the CRA does not need to recheck them at the initiation visit unless the sponsor specifically requests it.
False
Which of the following does not usually occur until an interim monitoring visit?
Performing data verification
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 close out visit is the only time that the monitor will do investigational product accountability
False
The CRA calls the site to confirm the close-out visit 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
What responsibilities of the Monitor?
Verifying that written informed consent was obtained before each subjects participation in the trial
Verifying that investigators are following the approved protocol
Checking the accuracy and completeness of CRF entries
When should the study close out visit be conducted
Once all subjects have discontinued use of the investigational product
It is 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. What will you need to consider?
Do the benefits to the child outweight the risks?
Who is the legally authorized representative consent?
Is there sufficient time to review the proposed research with the subject and his parents?
Is assent of the patient required?
What laws outlines US regulatory requirements for the protection of human subjects and vulnerable populations involved in federally funded research?
Title 45 Part 46
What is the most important factors to consider when conducting research in human subjects?
Rights of the subject
Well-being of the subject
Safety of the subject
In conducting ethical clinical research, which of the following is MOST important to do when using human research subjects?
Obtaining proper informed consent
What are potential consequences for not ensuring subject protections?
Harming human subjects
Jail time
The IRB must have only scientific members who are familiar with the product being studied
False
What is a consideration the IRB must make when deciding to approve a study?
Risks and benefits to study subjects
Approved Application
Application does not require modification
Approved Application with changes
Minor modifications are required
Tabled Application
Generates significant ethical questions, or appears to be scientifically unsound
Disapproved Application
Judged to be ethically or scientifically unsound
The day before a CRA is to conduct a SIV, CRC realizes that the IRB approval letter has not been received. What should the CRC do first?
Call the IRB to check on the status of the letter
A trial has been prematurely terminated for a trial evaluating an investigational proton pump inhibitor that is taken one pill b.i.d. Subjects are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus 2 additional doses. What represents a drug accountability issue?
Subject B returns 12 pills after 8 days on the trial
What percentage of trials as of 2015 are run electronically?
50%
The sponsor decided to broaden the inclusion/exclusion criteria to increase the allowable aldosterone level in a study. The next step the CRC should take is:
Notify the IRB of the change
When is informed consent obtained?
Before any study related procedures are performed
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