Practice Problems

A study treatment requires subjects to return every 14-16 days; dosing is 2 tablets, 4 times a day. A subject returns for study visit and has 16 tablets left. Were they compliant? A. yes, if day 14 B. no, if day 14 C. yes, if day 16 D. no, if day 16

A. Yes, if day 14

If a subject is hospitalized for more than 24 hours during the course of a study due to a fractured arm, it would be considered A. an SAE B. an AE C. an accident D. drug-related

A. an SAE

A CRC has been obtaining informed consent. They are keeping the original consent form for the PI, and giving a copy to the subject. What else should the PI ensure is carried out? A. documenting in the case history that informed consent was obtained prior to the conduct of any research-related procedure. B. having the CRC date all the signatures on the ICF C. putting copies of the ICF in the subject's medical records D. providing a copy of each signed ICF to the IRB

A. documenting in the case history that informed consent was obtained prior to the conduct of any research-related procedure

which of the following design methods would best be used for a study keeping both the subject and the PI/site staff from knowing which treatment the subject is receiving? A. double blinded B. interpretive bias C. bias reduction

A. double blinded

payments to subjects in clinical trials should: a. never be done b. be done only for phase 1 trials c. be done only with prior IRB approval d. be done only once, at the end of a subjects trial involvement e. never be more than $100 for completing a study

c. be done only with prior IRB approval

a source document is any document where: a. lab values are shown b. HIPAA authorization was received c. data are first recorded d. a subject's name is shown e. sponsor access to the document is not allowed

c. data are first recorded

if the short form method is utilized, the witness shall sign ____. a. copy of the summary b. short form c. short form and copy of summary d. consent form

c. short form and copy of summary

which of the following is not listed on FDA form 1571: a. name, address, phone number of sponsor b. a commitment not to start the clinical investigation until the IND is in effect c. identification of the phase of a trial d. approved informed consent document

d. approved informed consent document

financial disclosure applies to: a. only the PI b. the PI and CRC c. anyone at the site who is involved in the trial d. only those people listed on the 1572 e. the PI, CRC, and pharmacist

d. only those people listed on the 1572

__________ are the two most important design techniques for avoiding bias in a clinical trial a. randomization and stratification b. randomization and unblinding c. randomization and endpoints d. randomization and blinding

d. randomization and blinding

Most sponsors will expect an investigative site to keep all study records for how long? a. 15 years b. 3 years c. 5 years d. until the sponsor says they must be destroyed e. two years after the last subject finished treatments

d. until the sponsor says they must be destroyed

potential reasons to discontinue a subject in a trial are: a. the subject is not compliant with study procedures b. the subject has an intolerable medical event during treatment c. pregnancy d. A & B e. A, B & C

e. A, B & C

there are two main reasons that a sponsor might audit a study site. They are: a. the IRB has requested a sponsor audit b. to ensure the site is complying with the regulations and protocol c. there is evidence that the site is out of compliance and the sponsor wants to verify whether or not this is true d. A and B e. B and C

e. B and C

By regulation, an investigator must keep records relating to: a. disposition of the study drug b. case histories c. case report forms d. signed informed consent forms e. all of the above

e. all of the above

standard operating procedures are essential for: a. standardizing processes b. ensuring the regulatory requirements are met c. training new personnel d. managing workload e. all of the above

e. all of the above

The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is required to return for follow-up visits at 30 days, 6 months, and 1 year. - At 30 days, protocol requires a physical exam, ECG and chest x-ray - At 6 months, the protocol requires a physical exam and ECG - At 1 year, the protocol requires a physical exam, ECG, and chest x-ray The hospital charges $75 for physical exams, $50 for ECG and $100 for chest x-rays. The 30 day and 1-year visits are considered SOC. How much should the CRC budget per year for the non-SOC visits? A. $125 B. $225 C. $450 D. $575

A. $125

the form ___ is the application for investigational new drugs (IND) A. 1571 B. 1572 C. 3500A

A. 1571

Informed consent is documented by: A. A written, signed, and dated informed consent form B. A witness signature C. The IRB chairperson D. The Investigator E. The subject's legally authorized representative

A. A written, signed, and dated informed consent form

The subject forgets to return study drug. Do you: A. Dispense the next treatment, have subject return both medicines at next visit B. Hold treatment until subject returns drug C. Have subject finish tablets left at home and return for the next bottle when first is empty D. None of the above

A. Dispense the next treatment, have subject return both medicines at next visit

At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, "The doctor told me I was very lucky, I might have died." Having this information, the MOST appropriate sequence of action is to inform the: A. PI, sponsor, IRB/IEC B. Sponsor, PI, IRB/IEC C. Sponsor, IRB/IEC, PI D. PI, IRB/IEC, sponsor

A. PI, sponsor, IRB/IEC

The FDA does not require the use of a written assent form; however, when a written assent process is appropriate or required by the IRB, the FDA strongly encourages the use of a separate assent form that is "child-oriented" and developmentally appropriate. A. True B. False

A. True

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the Untied States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. A. True B. False

A. True

A 15 year old wants to screen for a study. She is on spring break and her parents have given verbal permission. Her grandma brings her in for the screening visit with a letter from her parents approving medical care. Can she be screened for the study? A. no, a legal guardian must be present to sign the ICF B. yes, the grandma may sign as the legal guardian C. yes, the grandma may sign the ICF and attach the parents' permission letter D. Yes, anyone over 18 who brings a child in as under their custody may sign the ICF

A. no, a legal guardian must be present to sign the ICF

which of the following responsibilities falls under the jurisdiction of the FDA? A. oversight of regulation adherence in clinical trials B. approval of individual study sites C. direct management of clinical trials

A. oversight of regulation adherence in clinical trials

Which drug development phase might consist of normal, healthy volunteers that are given a new drug? A. phase I B. phase II C. phase III D. phase IIB E. phase IV

A. phase I

The type of clinical trial designed to prevent PIs from assigning those patients whom they think have the best prognosis is to what they believe is the superior therapy is: A. randomized B. stratified C. outcomes studies D. blinded control

A. randomized

When advertising for research subjects in a local newspaper, which of the following are most appropriate to be included? A. required age, gender, and diagnosis of eligible subjects B. possible benefits of participation, including improvement of disease C. name of sponsor D. name of study drug

A. required age, gender, and diagnosis of eligible subjects ("improvement of disease" is not allowed, as this has not been confirmed)

waivers of consent cannot be used when: A. research is FDA-regulated B. subjects have no capacity to consent and time is limited (emergency) C. in vitro diagnostic device studies D. studies are minimal risk

A. research is FDA-regulated

Who monitors the progress of all clinical trial investigations being conducted under its IND? A. sponsor B. PI C. IRB D. CRO

A. sponsor

which person(s) or agency would not be informed of the treatment assignment for a subject in a study using a single blind method of randomization? A. the subject B. the research team C. the FDA

A. the subject

the records of a subject who was previously enrolled in a clinical trial may be reviewed retrospectively, without reconsent, to collect additional information under certain limited circumstance, consistent with the original consent process. A. true B. false

A. true

when a short form is used for informed consent, the witness must sign either the short form or the summary A. true B. false

A. true

Which historical document discusses the purpose of the Internal Review Board? A. The Nuremburg Code B. Declaration of Helsinki C. 21 CFR Part 11 C. Belmont Report

B. Declaration of Helsinki

What is the primary reason for blinding individuals or groups to the assigned treatments in a clinical trial? A. it decreases the amount of unnecessary data collection B. It is intended to eliminate bias C. It is the only way to ensure accurate results

B. It is intended to eliminate bias

The responsibility of the participants safety lies with: A. sponsor B. PI C. IRB

B. PI

A PI has become a member of the local IRB and is conducting a study approved by the same IRB for which enrollment began 6 months ago and will continue for an additional 24 months. The CRC is submitting a protocol amendment, which will be reviewed/approved by the IRB. The CRC should be aware that the: A. IRB chair must allow the PI to deliberate and vote B. PI must abstain from the deliberation and voting process C. IRB chair must allow the CRC to deliberate and vote in place of the PI D. PI must abstain from the investigator duties during the deliberations and voting process

B. PI must abstain from the deliberation and voting process

The purpose of the IRB is to: A. Inform study subjects about the protocol and drug B. Protect the rights and welfare of human subjects in research C. Ensure sponsors are meeting FDA regulations D. Write easily understood consent forms

B. Protect the rights and welfare of human subjects in research

A(n) ______ is a printed, optical or electric document designed to record all of the protocol required information to be reported to the sponsor on each trial subject: A. SAE B. 1572 C. CRF

C. CRF

The purpose of the IRB is to: A. Inform study subjects about the protocol and experimental drug B. Respect the rights and welfare of human subjects in research C. Ensure sponsors are meeting FDA regulations D. Write easily understood consent forms

B. Respect the rights and welfare of human subjects in research

Ethical principals of respect for persons, beneficence and justice are outlined in: A. 45 CFR 46 B. The Belmont Report C. The Nuremburg Code D. Declaration of Helsinki

B. The Belmont Report

The CRC at a site sends in weekly screening logs for an osteoporosis study for which recruitment continues to be a site-specific problem. Which of the following would be the LEAST likely cause of the site's low enrollment? A. the study budget is too low B. The clinic is not open on Saturdays C. subjects screened are too young for the disease under investigation D. the CRC is running too many studies

B. The clinic is not open on Saturdays

During the course of a clinical study, which of the following items would a sponsor most likely reimburse a site? A. an increase in subject stipend B. additional tests or visits due to an AE C. a hospitalization occurring during a study D. prescriptions ordered during study participation

B. additional tests or visits due to an AE

A subject dies 2 days before a long-term follow-up visit and had been off the study drug for 2 weeks. This would be reported as A. an AE B. an SAE C. a side effect D. early termination

B. an SAE

the PI must obtain IRB approval of the study and the consent form: A. before the study has been completed B. before enrolling any patients C. before receiving any grant money for the study D. before the first patient has completed the study

B. before enrolling any patients

A PI requests that the CRC maintain the IP accountability log in the research office, even though a pharmacy is responsible for storing and dispensing study drug. The CRC may best respond to this request by A. maintaining the accountability log in her office according to regulations B. explaining to the PI that the log should be maintained in the pharmacy where the IP is dispensed C. requesting that the monitor explain the regulations regarding the responsibilities and obligations of the PI D. suggesting the PI read the regulations related to storage and dispensing of IP

B. explaining to the PI that the log should be maintained in the pharmacy where the IP is dispensed

the international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as: A. ICH B. good clinical practice (GCP) C. fundamental ethical principals D. the declaration of Helsinki E. FDA code of federal regulations (CFR)

B. good clinical practice (GCP)

According to the CFR, an unexpected adverse drug experience (ADE) is A. one that occurs occasionally in a subgroup of subjects, but is not believed to be associated with the IP B. one that is not identified in nature, severity, or frequency in the current labeling, IB, general investigational plan, or elsewhere in the IND C. any reaction that's listed in the IB, but is not listed in the Product Labeling due to infrequency of occurrence D. a fatal or an immediately life-threatening clinical experience, birth malformation, permanently disabling event, any event that requires prolonged inpatient hospitalization

B. one that is not identified in nature, severity, or frequency in the current labeling, IB, general investigational plan, or elsewhere in the IND (D is an SAE)

what are the two main themes covered by the formal ICH definition of "good clinical practice"? A. right and well-being of study subjects and compliance with regulations B. rights and well-being of study subjects and credibility of data C. compliance with regulations and credibility of the data D. compliance with the regulations and the formal marketing approval process E. credibility of the data and international consistency

B. rights and well-being of study subjects and credibility of data

A drug's safety is determined by which of the following criteria: A. the dose at which no side effects are reported B. the absence of harmful side effects on the individuals exposed so far C. the FDA's review of source documentation at a clinical site

B. the absence of harmful side effects on the individuals exposed so far

which signatures are required by regulation to be on the consent form? A. the PI B. the subject C. the PI and the subject D. the subject and the witness E. the PI, the subject, and the witness

B. the subject

Which of the following would generally indicate the breaking of a randomization code in a blinded study? A. The participant withdraws from the study prior to its conclusion B. Only participants at one of the sites shows any definitive response to treatment C. A participant experiences an SAE, the etiology of which cannot be explained (or anticipated)

C. A participant experiences an SAE, the etiology of which cannot be explained (or anticipated)

the immediate package of an investigational new drug intended for human use shall bear a label with the statement: A. "caution: for FDA research purposes only" B. "caution: new drug - limited known side effects" C. "cation: new drug - limited by federal (or US) law to investigational use" D. none of the above

C. "cation: new drug - limited by federal (or US) law to investigational use"

The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the IM. Following the meeting, the eligibility criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start-up, the regulatory binder must include: 1. An IRB/IEC letter of approval for the amended protocol 2. An IRB/IEC site evaluation form 3. The amended protocol 4. The Investigator's Brochure A. 1 & 2 B. 2 & 4 C. 1 & 3 D. 3 & 4

C. 1 & 3

An unexpected SAE involving a fatal or life threatening AE must be reported to the FDA no later than ___ calendar days after the sponsors initial report of the information. A. 5 B. 10 C. 7 D. 30

C. 7

Which of the following documents are most cited when conducting human subject research? A. Food Drug & Cosmetic Act, Declaration of Helsinki, and the Belmont Report B. Food and Drug Law, Nuremburg Code, and the Public Health Code C. Declaration of Helsinki, Nuremburg Code, and the Belmont Report

C. Declaration of Helsinki, Nuremburg Code, and the Belmont Report

A pharmacoeconomic study is an example of what type of study? A. Exploratory B. Confirmatory C. Post Approval D. Human pharmacology

C. Post Approval

An ICF was sent home with a potential study subject on Friday with a visit scheduled for Monday. The subject signed and dated the ICF over the weekend. On Monday, the CRC notices while discussing the informed consent document. Which is the MOST appropriate action for the CRC to take? A. Notify PI and sponsor of event B. Submit a discrepancy report to the IRB C. Reconsent the subject with a new ICF with a notation D. Sign and date the ICF during the Monday visit

C. Reconsent the subject with a new ICF with a notation

As a CRC coordinating a cardiac medical device study, which of the following would generally be considered the most qualified person to monitor your site? A. a cardiologist not associated with the PI B. the engineer who developed the device C. a nurse with an understanding of the study and monitoring experience D. the IRB/IEC chairperson

C. a nurse with an understanding of the study and monitoring experience

According to CFR, which of the following must the investigator report to the IRB? A. any subjects considered lost to follow up B. disclosure of any financial interests in the sponsor of the study C. a protocol change reducing the number of blood draws

C. a protocol change reducing the number of blood draws

non-clinical studies refer to studies that do not involve: A. animal testing B. drugs C. human subjects D. toxicology parameters E. safety

C. human subjects

Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the: A. mission statement of the ICH B. mission statement of the declaration of Helsinki C. mission statement of the GCP guidelines D. mission statement of Canada Health

C. mission statement of the GCP guidelines

larger, multicenter studies are usually done in: A. phase I B. phase II C. phase III D. phase IIB E. phase IV

C. phase III

Which of the following terms is best defined as "a pharmaceutical preparation that contains no active agent" A. blinded B. non-invasive C. placebo

C. placebo

If a subject in a long-term, open-label maintenance study requires a knee replacement surgery, which of the following is true? A. it is not necessary to file an SAE report B. the subject may continue with no interruption in study medication assuming the study is in Phase IIIB C. the sponsor should determine if the subject should remain in the study D. the admitting hospital's IRB must give approval for the subject to continue the study medication

C. the sponsor should determine if the subject should remain in the study (SAE likely required due to long hospital stay; phase of study doesn't matter)

Which of the following items should be included in the formal closeout report from the site to the IRB? 1. total number of subjects enrolled 2. date the IRB approved the study 3. date the last subject was enrolled 4. total number of adverse events that occurred A. 1, 2 and 3 B. 1, 3 and 4 C. 2, 3, and 4 D. 1, 3, and 4

D. 1, 3, and 4

A study treatment requires subjects to return every 14-16 days; dosing is 2 tablets, 4 times a day. How many tablets should be in the bottle? A. 112 B. 148 C. 158 D. 128

D. 128

Which of the following might be considered sources in order for determining local lab costs? 1. previous budget with this sponsor 2. laboratory director 3. PI 4. lab fee schedule A. 1 and 3 B. 1 and 4 C. 2 and 3 D. 2 and 4

D. 2 and 4

What is the minimum number of members required by an IRB? A. 8 B. 6 C. 2 D. 5

D. 5

phase 1 studies may be conducted in _____. A. patients B. animals C. normal volunteer subjects D. A & C

D. A & C

Class 3 devices... A. no potential for risk or injury B. require premarket approval C. support or sustain life D. B & C

D. B & C

what is a person or organization contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function? A. CRO - contracted research operations B. CRO - clinical research organization C. CRO - center for research operations D. CRO - contracted research organization

D. CRO - contracted research organization

A pharmacokinetic study is an example of what type of study? A. Exploratory B. Confirmatory C. Post Approval D. Human pharmacology

D. Human pharmacology

Which of the following is PHI that requires compliance with HIPAA prior to transmitting? I. age in years II. medical record numbers III. date of death IV. address A. I, II, and III only B. I, II, and IV only C. I, III, and IV only D. II, III, and IV only

D. II, III, and IV only

If a sponsor discovers that data was deliberately falsified, which of the following is most likely to happen immediately? A. All sites will be closed B. The Sub-I will be appointed as PI C. the PI will be prevented from practicing medicine D. No further IP will be sent to the PI

D. No further IP will be sent to the PI

The individual responsible for ensuring that data queries are reviewed and clarified at the study site is the: A. Sub-I B. Study pharmacist C. Study coordinator D. PI

D. PI

For initial approval of proposed research, the investigator must submit to the IRB: A. A protocol synopsis and Investigators Brochure B. The informed consent and protocol synopsis C. The full protocol D. The full protocol and informed consent

D. The full protocol and informed consent

Informed consent documents must include the following: A. a statement that the study involves research B. a statement of possible risk C. a discussion of possible alternative treatments D. all of the above

D. all of the above

When does a study site become responsible for submitting IND safety reports to the IRB? A. after subject screening procedures begin B. after the first subject enrolls C. after the test article is received D. as soon as reports are received from the sponsor

D. as soon as reports are received from the sponsor (IND safety reports are sent to sites by the sponsor updating safety info in the IB. These are submitted to the IRB as soon as they're received)

______ is not a basic element of informed consent. A. description of clinical investigations B. voluntary participation C. contacts D. number of participants

D. number of participants

Which of the following are necessary to waive consent? A. Subject is unable to give consent B. No time or unable to contact next of kin C. Life-threatening condition D. No other treatment available E. All of the above

E. All of the above

the process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as: A. HIPAA authorization B. IRB approval C. Legally authorized agreement D. Intent to treat E. Informed consent

E. Informed consent

ICH guidelines provide a unified standard for __________ clinical trials involving human subjects. A. designing B. conducting C. recording D. reporting E. all of the above

E. all of the above

what are the three fundamental ethical principals for human subjects research? A. informed consent for participation in research B. fair distribution of cost/benefit ratio C. maximizing benefits, minimizing risks D. autonomy of patients E. respect for persons F. non-exploitative and well-considered procedures G. justice H. beneficence

E. respect for persons G. justice H. beneficence

there are 3 classifications that result from an FDA audit. The one that means deviations from regulations were found but they were not serious is: a. VAI b. NAI c. OAI d. BIMO-2 e. EIR

a. VAI

A ____ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation. a. advocate b. parent c. witness d. none of the above

a. advocate

the person who obtains informed consent of a subject must: a. have IRB approval to consent subjects b. complete blanks for the subject c. sign as the witness d. be the PI of the study

a. have IRB approval to consent subjects

any individual assisting with the management of a study including consenting subjects or extracting data should be listed as key personnel. a. true b. false

a. true

if the study is submitted in support of an IND, the records must be kept for _____ after the date the marketing application is approved. a. 1 year b. 2 years c. 3 years d. eternity

b. 2 years

the FDA shall provide a written determination ________ after the FDA receives the IND or earlier. a. 15 days b. 30 days c. 2 months d. 1 year

b. 30 days

if no subjects are entered into clinical studies for a period of 1 year or more under an IND, the IND may be placed on inactive status by the FDA a. true b. false

b. false (2 years)

which of the following would not indicate an observational study? a. investigator assessing health outcomes in a group according to a protocol b. investigator assigns a medical product to individuals as part of his research design c. investigator is looking at eating habits of children and its association to hyperactivity d. investigator is looking at cognitive recovery after SOC anesthesia regimen

b. investigator assigns a medical product to individuals as part of his research design

the formal evaluation of the quantitative evidence from two or more trials bearing the same questions is known as a _____. a. interim analysis b. meta-analysis c. blind review d. analysis plan

b. meta-analysis

by regulations, investigators are required to make final study reports to: a. the FDA and sponsor b. sponsor and IRB c. the institution d. sponsor, IRB, and FDA e. the sponsor

b. sponsor and IRB

The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than _____ after the sponsor's initial receipt of the information a. 7 working days b. 14 calendar days c. 7 calendar days d. 21 working days

c. 7 calendar days

"life-threatening" means: a. diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted b. diseases or conditions with potentially fatal outcomes, where the end point of the clinical trial analysis is survival c. none of the above d. a and b

d. a and b

a _____ lists the investigator's education, training, and experience that qualifies them as an expert in the clinical investigation of the drug for the use under investigation. a. CV b. letter from fellow investigator c. statement or qualifications of the investigator d. a and c

d. a and c

a contract research organization shall be responsible for _____. a. obtaining information from the investigator b. control of the drug c. selecting investigators d. all of the above

d. all of the above

a protocol is required to contain _____. a. a description of the observations and measurements to fulfill the study's objectives b. a description of the clinical procedures and lab procedures c. a statement of the objectives and purpose d. all of the above

d. all of the above

an IEC/IRB ensures the protection of _____ of human subjects in a clinical trial. a. safety b. rights c. well-being d. all of the above

d. all of the above

phase 4 studies could include _____. a. using the drug over a longer period of time b. use of the drug in other patient populations c. use of the drug in other disease stages d. all of the above

d. all of the above