OLD CRM test questions
If a Warning Letter is issued, how many working days from receipt of the warning letter does the PI have to respond in writing to the FDA?
15
Which part of the US code of federal regulations (CFR) would you find requirements for electronic medical records used in conduct of human clinical research trials?
21 CFR 11
Which of the US CFR would you find a listing of requirements for product accountability of an investigational drug?
21 CFR 312
In which part of the US CFR would you find elements of informed consent?
21 CFR 50
Which part of the US CFR would you find a definition of a significant equity interest requiring disclosure?
21 CFR 54
Which part of the US CFR would you find requirements for financial disclosure by investigators?
21 CFR 54
Which part of the US CFR would you find requirements for the composition of an IRB?
21 CFR 56
FDA regulations governing medical device clinical investigations in the US include which of the following:
21 CFR 812
Which part of the US CFR would you find a listing of responsibilities for investigators conducting device trials involving human subjects?
21 CFR 812
Which part of the US CFR would you find sponsor obligations related to an investigational device study?
21 CFR 812
Which part of the US code of federal regulations (CFR) you would find requirements for product accountability of an investigational device?
21 CFR 812
You are a product manager at a medical device company in charge of ensuring the company's newest medical device follows the most appropriate regulatory pathway to approval. The device is classified as a significant risk Class III device. No predicate device exists. Which of the following are required in order to remain in compliance with federal regulations: 1--IND prior to starting clinical research 2--NDA to obtain marketing approval 3--IRB review and approval throughout a study 4--Compliance with IDE regulations in order to submit PMA 5--FDA approval of 510(k) prior to starting clinical research
3 and 4 only
Which part of the US CFR would you find basic policy for the protection of human research subjects in federally-funded studies?
45 CFR 46
You are a regulatory affairs officer at a medical device company. The company's newest creation is a combination drug/device product. Your company will try to provide substantial equivalence to an existing product. Which of the following describes the regulatory pathway to market approval associated with this strategy?
510(k)
You are a clinical research coordinator at a research site conducting a medical device trial to test and experimental drug-eluting cardiac stent. You have been delegated the task of screening patients for enrollment. It is a busy day in the clinic and you screen four new patients for potential enrollment in the clinical trial. Which of the following patients has diminished autonomy and may require additional protections?
62 year old male on continuous Morphine drip after emergency triple bypass surgery
In the US, regulatory inspections for clinical research are conducted by:
FDA
Which of the following is charged with protecting the public and responsible for ensuring products marketed and sold in the US are safe and effective?
FDA
You are a product manager developing a timeline for the upcoming clinical research study on an unapproved device. Who determines the classification of your unapproved device?
FDA
Which of the following is NOT a true statement regarding FDA inspections?
FDA inspectors must have a warrant to inspect investigators and review subjects' medical records
Which of the following describes international guidelines directed towards investigators, sponsors, and review boards involved in the conduct of human clinical research trials?
ICH E6
The application to study a new drug in the US is known as a(n):
IND
US title 21 part 56 describes federal regulations for:
IRB
drug and device research involving human subjects must be approved by an
IRB
ICH is an abbreviation for:
International Conference on Harmonisation
The Declaration of Helsinki states "The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins." In the US, this research ethics committee is called:
International Review Board
Which of the following US federal regulations describes the responsibilities of sponsor and investigators conducting drug research?
US title 21 part 312
Widget Inc., a small pharmaceutical company, is moving into clinical trials for the product Widget A. The company reaches out to various physicians who may be interested in participating in a clinical trial using this product. Dr. Smith, chief of staff at a local hospital, agrees to participate in this clinical trial. In this scenario, who is the sponsor?
Widget Inc.
Which of the following describes federal regulations designed to encourage the development of drugs designed to treat illnesses affecting a very small population in the US?
a product intended for a disease of condition that affects fewer than 200,000 people in the US
You are working at an investigative site conducting a clinical research trial using an already approved drug. Which of the following is TRUE? a. you do not need to prove substantial equivalence b. you do not need to obtain IRB approval c. you do not need to adhere as closely to the protocol d. you do not need to obtain informed consent
a. you do not need to prove substantial equivalence
Which of the following best describes "informed consent" as it applies to clinical trials?
an ongoing process consisting of an exchange of information between subject and investigator
Principal Investigators:
are 100% responsible for all clinical research activities at their research site
According to ICH guidelines, a sponsor's audit is conducted to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and applicable regulatory requirements. The audit should also:
be independent of and separate from routine monitoring
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or allergenic product, or analogous product, or arsphenamine or derivative or arsphenamine applicable to the prevention, treatment or cure of a disease or condition of human beings is also known as which of the following?
biologic
You are working at a medical device sponsor as a regulatory affairs manager. Your job is to ensure the company's two newest products (device Y, device Z) follow the most appropriate regulatory pathway to market approval by the FDA. The product development plan for device Z requires an IDE to be filed. Which of the following most likely represents device Z? a. class III non-significant risk b. class II significant risk with a predicate device c. class III significant risk d. class I non-significant risk
c
You are an FDA inspector. You are conducting an inspection in the US at a clinical research site. The study you are currently focusing on is following ICH standards. Which of the following is TRUE? a. ICH guidelines do not require IRB approval b. US federal regulations prohibit an investigatory from following ICH guidelines c. the principal investigator must follow ICH guidelines d. US federal regulations overrules ICH guidelines because US federal regulations are more strict
c the principal investigator must follow ICH guidelines
According to our discussion during class, which of the following groups would be considered a vulnerable subject?
children, pregnant, under the influence
Which of the following statements is correct about clinical research studies conducted in accordance with the US code of federal regulations?
compliance with US federal regulations does not ensure compliance with ICH GCP
Which of the following terms describes a formal process for reacting to and fixing an existing problem and implementing processes to prevent future non-conformity?
corrective and preventive action (CAPA)
US Title 45 CFR 46 a. specifically addresses protections for vulnerable population b. applies to all federally funded clinical research c. provides guidance for experimental research in animals d. both A and B
d. both A and B a. specifically addresses protections for vulnerable population b. applies to all federally funded clinical research
The office of combination products:
designates which FDA center has primary jurisdiction of the combination product based on the product's primary mode of action
Which of the following does not achieve its primary intended purpose through chemical action within or on the body of man or other animals and is not dependent on being metabolized for the achievement of its primary intended purpose?
device
Which of the following most likely represents the initial identification of compounds or molecules that may be candidates for further study?
discovery
By definition, which of the following is a substance (other than food) intended to affect the structure of any function of the body of man or other animals and is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals?
drug
the FDA inspector is required to present this document, also known as "notice of inspection" at the beginning of an inspection:
form FDA 482
At the conclusion of the inspection, the FDA inspector may provide this document, also known as the "list of inspectional observations":
form FDA 483
Which of the following regulatory paths are available for the development of devices for rare conditions (affects or is manifested in fewer than 4000 individuals in the US per year), similar to the orphan drugs for devices?
humanitarian device exemption
Orphan drugs are designated based on:
incidence rate of disease/condition in the US
Of the following, which is the most important aspect for ethical conduct of clinical research?
informed consent
Which of the following FDA inspections would most likely be considered a "directed" inspection?
inspection at the highest enrolling site in a study
US title 21 part 812 describes federal regulations for:
investigational device research
The main difference between drug and device development in the US is:
investigational device research depends on a class-based and risk-based determination
US title 21 part 312 describes federal regulations for:
investigational drug research
Form FDA 1571 is also known as:
investigational new drug application (IND)
Which of the following is FALSE regarding the Willowbrook Hepatitis experiments? a. the benefits of the study did not outweighed the risks b. subjects in the study are from a vulnerable population c. investigators closely adhered to the principles outlined in the Belmont Report d. investigators violated some of the principles outlined in the Declaration of Helsinki
investigators closely adhered to the principles outlined in the Belmont Report
which of the following is a principle of the Belmont Report?
justice, respect for persons, beneficence
Preclinical research involves:
laboratory testing that is predictive of what will happen in human studies
You are a 4th year medical student conducting rotations at a local hospital. As part of your adult oncology (cancer) rotation, you are leading a team of medical students assigned to develop a medical device research protocol designed to identify if patients tolerate treatment A better than treatment B. Both treatments have been proven beneficial and both require the devices to be surgically implanted. During a meeting one of the medical students suggests using a placebo control as part of the study. Should this research have a placebo control as part of the study? a. unknown at this time, this is a decision on the IRB can make
no, research must always at least provide the standard of care and the risks of a surgery using a placebo more than likely do not outweigh the benefits
Which of the following classifications of an FDA inspection typically results in the issuance of a warning letter?
official action indicated
Pharmacokinetic testing is very extensive, time consuming, and helps researchers identify the overall safety profile of the drug. Which of the following phases of drug research is most likely associated with pharmacokinetic testing in human subjects?
phase I
Which phase of study is most commonly conducted as open label investigations in healthy volunteers?
phase I
You are an investigator conducting a study on an unapproved investigational cancer drug. The study is being conducted on the intended patient population which are patients with stage IV lunch cancer who have not responded to conventional treatment. This is the first time the drug is being tested in humans and the primary objective of this study is safety. Which phase(s) of the investigational drug development process does this most likely represent?
phase I
An unapproved investigational acne medication is being studied on a relatively small group of adolescent teens with uncontrolled facial acne. The primary endpoint of this study is safety. The secondary endpoints are effectiveness and maximum tolerable dose. Which phase of research would most likely be associated with this study?
phase II
Which of the following phases of drug research is most likely associated with global multicenter clinical trials?
phase III
Which phase of the drug development process prior to market approval generally focuses on safety, effectiveness, and overall risk-benefit assessment?
phase III
You are a PI. A new drug study is about to begin and you attend the Investigator's Meeting. The sponsor states this study is their "pivotal study" for the investigational drug. Which phase of clinical research most likely represents this study?
phase III
You are conducting clinical research trial using an FDA approved drug. The purpose of the study is to compare the effectiveness of the drug versus the leading market competitor. The study is being conducted in accordance with the approved product labeling and is anticipated to enroll approximately 100 subjects. Which phase of study does this most likely represent?
phase IV
A class II medical device:
presents some risk and must meet performance standards
The mission of the IRB is to:
protect the rights and welfare of human subjects engaged din biomedical research
The most important responsibility of all researchers is to:
protect the rights, safety, and well-being of research subjects
You are an auditor for a medical device company conducting an audit on five investigative sites currently active in a pivotal trial. The five sites are the highest enrolling sites in this trial and are known for their experience in conducting clinical research trials. The main objective of your audit will be to determine each site's level of compliance with the requirements of the clinical study and if each site has a system for managing any issues discovered. Which of the following elements will you need to evaluate?
protocol compliance and the handling of deviations
Which of the following activities is NOT the legal responsibility of clinical investigators involved in an industry sponsored investigational medical device trial?
protocol design and development
You are an auditor for a medical device company conducting an audit on five investigative sites currently active in a pivotal trial. The five sites are the highest enrolling sites in this trial and are known for their experience in conducting clinical research trials. While at a different site, you are able to find documentation that informed consent was obtained for each subject but you also discover numerous inconsistencies on the informed consent documents for several subjects. After discussing this with the investigator, the investigator states he has developed a SOP detailing how to properly obtain informed consent. Which of the following process changes should you recommend?
recommend the site implement a training program for all study personnel on how to properly deliver and document the informed consent process
Depression affects millions of patients every year in the US and is a $17 billion market worldwide. You are part of a company developing a new product which combines an unapproved investigational anti-depressant medicine and a transdermal patch. The product is designed to conveniently deliver the investigational anti-depressant over the course of 30 days. The FDA determines the primary mode of action is therapy received from the anti-depressive medication. Which of the following regulatory pathways would most likely apply to this product?
regulatory pathway for a drug
Clinical research monitors (commonly referred to as Clinical Research Associates):
represent the sponsor
US laws pertaining to clinical research have been influenced by public opinion and are often the result of tragedy or public demand. The Sulfanilamide Elixer tragedy resulted in the deaths of many children and was the impetus for the 1938 Food, Drug and Cosmetic Act. According to our discussion in class, this act was the first federal law requiring proof of what?:
required proof of safety
Clinical research involves:
research in humans
Why are devices classified by risk?
risk-based classification allows for FDA to apply more stringent control over higher risk products to ensure safety while minimizing regulatory burden on lower risk products to promote innovation
The primary purpose of phase one clinical research is to determine:
safety
Sponsors are responsible for:
selecting qualified investigative sites
Results and conclusions from unethical clinical research practices:
should not be published or referenced and are considered invalid
Which of the following individuals has a duty to maintain and provide ethical oversight for all human research subjects?
sponsor, clinical research coordinator, principal investigator, sub investigator
Choose the best answer: in clinical trials involving human subjects, who works to ensure compliance is maintained at the investigative site?
sponsor/monitor, IRB, PI, and all site personnel assigned to the study
Which of the following statements is FALSE?
sponsors cannot submit clinical trial data to the FDA if the trial was conducted in another country
Which of the following terms describes detailed written instructions to achieve uniformity of a specified function?
standard operating procedure (SOP)
Good Clinical Practice (GCP) can be described as:
standards for the conduct of clinical research
You are an FDA inspector conducting an inspection at a local hospital for a medical device trial. Which of the following is appropriate and therefore is NOT an observation that would be reported on a warning letter?
study coordinator reported serious adverse events to the IRB as per IRB guideline
You are an FDA inspector conducting an inspection at a local hospital for a medical device trial. At the end of the day, you meet with the PI to discuss your observations. The first observation you discuss is a lack of documentation in each subject's medical records describing the informed consent process. Which of the following is an acceptable response by the PI?
the PI states she is 100% responsible for the conduct of the trial and outlines a plan for correcting this lack of documentation and preventing this lack of documentation from reoccurring
The closure of the Tuskegee Study led to the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and subsequently the Belmont Report. Which of the following is FALSE regarding the Tuskegee Study? a. none of the above are true b. investigators did not provide subjects the standard treatment for Syphilis when it became available c. the benefits outweighed the risks d. subjects in the study are from a vulnerable population
the benefits outweighed the risks
You are an auditor for a medical device company conducting an audit on five investigative sites currently active in a pivotal trial. The five sites are the highest enrolling sites in this trial and are known for their experience in conducting clinical research trials. Which of the following audit observations found at one of the sites may be indicative of fraud?
the investigator's signature on case report forms in black ink yet the signature is dated in blue ink
Which of the following is an example of protocol non-compliance (protocol deviation)?
the protocol requires a day 15 CT scan. The PI orders an MRI on day 15
Which of the following statements is the most important consideration for clinical researchers?
the rights, safety, and well-being of trial subjects should prevail over interests of science and society
The ICH guidelines for informed consent are more detailed than FDA regulations. Which of the following informed consent elements is required by ICH but NOT required by the US FDA?
the risks and benefits of alternative treatments
You are an auditor for a medical device company conducting an audit on five investigative sites currently active in a pivotal trial. The five sites are the highest enrolling sites in this trial and are known for their experience in conducting clinical research trials. At one of the sites, you note a trend in the data and source documents that may potentially be a threat to the integrity of the clinical trial data. Which of the following would pose a threat to the integrity of the clinical trial data?
the site did not report the occurrence of numerous serious adverse events to the sponsor
Which of the following is an example of a class I device?
tongue depressor
TRUE OR FALSE: all FDA centers conduct inspections
true
TRUE OR FALSE: the following are possible consequences for non-compliance in clinical trials involving human research subjects: -integrity of research data may be compromised -safety profile of investigational product may be inaccurate -disbarments and/or criminal prosecution
true
Which of the following is an example of a class III device?
vertebral implant
Clinical research coordinators:
work immediately under the direction of a principal investigator in accordance with GCP
Is it ethical to pay human subjects for participating in clinical research trials?
yes, but only if the subject receives segmented (pro-rated) compensation fort their participation throughout the trial and the amount is approved by the IRB
You are a physician recently appointed to oversee all clinical research trials at a major metropolitan hospital. You hold a meeting with all the PIs. During the meeting, one of the PIs asks whether they should be complying with US Title 21 regulations or with ICH guidelines. Which of the following would BEST help you to determine the proper regulations to follow?
you state all research in the US must at least comply with the applicable parts of title 21. However, if the protocol states ICH guidelines must be followed, then ICH guidelines will need to be followed
