Practice Test Flashcards by Abbey V

Which of the following scenarios are considered SAEs? (2)
A. Infection following surgery prolonging hospital stay
B. Pregnancy resulting in normal delivery of twins
C. Boating accident with overnight hospitalization
D. Use of illicit drug during trial

A and C

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Which of the following are responsibilities of IDMC/DSMB? (2)
A. Assess the financial aspects of a trial
B. Assess the progress of a trial
C. Recommend initiating a trial
D. Recommend stopping a trial

B and D

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A trough blood level for a once-daily drug should be drawn how long after dose?
A. 24 hours
B. 20 hours
C. 48 hours
D. 15 hours

A. 24 hours

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A CRA calls a CRC to schedule the final monitoring visit. The sponsor requires that the PI be present. The only dates available for the CRA conflict with the PI’s schedule. To prepare for the visit, the CRC should:
A. Reschedule the visit
B. Have a PI sign all documents prior to the visit
C. Discard unused trial documents
D. Notify the IRB/IRC

A. Reschedule the visit

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A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation code list, documentation of IP destruction and final report to the IRB/IEC. Which of the following actions should the CRC perform? (3)
A. Send the treatment decoding documentation to the sponsor
B. Remove the subject identification code list from the material to be sent to the sponsor
C. Send copies of the IP destruction forms to the sponsor
D. Remove the drug accountability log from the material to be sent to the sponsor

A, B, and C

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A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medications. Which of the following questions should be asked by the CRC? (2)
A. When was the last time your medication dose changed?
B. Have you made any dieray changes in the last month?
C. When was your last chest x-ray and ECG?
D. Do you have any difficulty swallowing oral medications?

A and D

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A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more inclusion/exclusion criteria. How long will it take the CRC to fulfill enrollment?
A. 6 weeks
B. 5 weeks
C. 7 weeks
D. 8 weeks

A. 6 weeks

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What is the expected job growth for CRCs over the next decade?
A. Decline by 5%
B. No significant change
C. Grow by 10%
D. Grow by 20%

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The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken one caplet orally b.i.d. for chronic hip pain. Subject are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug accountability issue? (B.I.D= twice a day)
A. Subject A returns 24 pills after 10 days on trial
B. Subject B returns 12 pills after 8 days on trial
C. Subject C returns 29 pills after 5 days on trial
D. Subject D returns 42 pills after 1 days on the trial

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A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he?
A. 30%
B. 20%
C. 50%
D. 25%

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A subject is participating in a clinical trial where only the pharmacist and the sponsor know the identity of the IP. The pharmacist has no direct contact with the trial subject and the clinical team. Which of the following BEST describes this trial type?
A. Double-blind
B. Triple-blind
C. Single-blind

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A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would MOST likely involve (2)
A. Healthy volunteers
B. Pharmacokinetic
C. Placebo control
D. Dose escalation

B and D

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The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigator’s meeting.
Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start-up, the regulatory binder must include: (3)
A. An IRB/IRC letter of approval for the amended protocol
B. An IRB/IRC site valuation form
C. The amended protocol
D. The investigator’s Brochure

A, C, and D

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According to the general principles of the Deceleration of Helsinki, the responsibility for the protection of research subjects must always rest with the _____________.

Physician

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Which statement is primarily for physicians?
A. Nuremberg Code
B. Declaration of Helsinki
C. Belmont Report

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One of the three basic principles of the Belmont Report, Respect for persons, is done through ______________.

Informed consent

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One of the three basic principles of the Belmont Report, Justice, is done through….

Selection of Subjects

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The sponsor obtains an agreement from the investigator/institution for adherence to the protocol, to obtain IRB approval, and GCP compliance. This agreement is known as….

Form 1572

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One of the three basic principles of the Belmont Report, Beneficence, is done through….

Risks and Benfits

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How does a sponsor secure compliance of a clinical trial at the site level?

Through monitoring

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21 CFR part 11 regulates?

Electronic signature

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What is the name of FDA Form 483?

Inspectional Observation

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What does 21 CFR 56 regulate?

Institutional Review Board (IRB)

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An application for investigational device exemption is part of 21 CFR part ___________?

812

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Define electronic signature

A computer data compilation of any symbol or series of symbols executes, adopted, or authorized by an individual to be legally binding equivalent of an individual's handwritten signature

21 CFR 50, subpart D refers to safeguards for which population?

Children in clinical investigations

The regulations in CFR part 11 set forth the criteria under which that agency considers electronic records, electronic signatures, and handwritten signatures to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signature executed on paper True or Flase

True

Define clinical investigation:

Any experiment that involves a test article and one or more human subjects and that either: - is subject to requirements for prior submission to the FDA under section 505(i) or 520(g)-OR is not subject to requirements for prior submission but the results of which are intended to be later submitted -or held by inspection by the FDA as a part of an application for a research or marketing permit

What does 21 CFR 50 regulate?

FDA protection of human subjects

21 CFR 11.2, subpart A is only for electronic records required to be maintained that must be submitted to an agency. True or False

False

In 21 CFR 11.1, subpart A, what requirements must electronic records meet?

They must be in accordance with part 11.2, unless paper records are specifically required

What does 21 CFR 11.2, subpart B cover?

Electronic Records

What is another name for ICH guideline is E6?

GCP- Good clinical practice

21 CFR 50 refers to protection of human rights that also regulate food additives. True or false?

True

What FDA Regulation allows investigators to withdraw a subjects participation at any time?

21 CFR 50.25 (B) (2)

What do FDA regulations mandate for sponsors regarding the investigators brochure?

Provide at the beginning and keep investigators informed of new AEs

How soon must a sponsor conduct an investigation of unanticipated adverse device effects?

Immediately

For device trials, to whom must sponsors submit semi-annual progress reports in addition to the annual report under a treatment IDE?

To all reviewing IRBs and FDA

What defines a closed system?

Access controlled by overseers of content

Who must be considered when reporting a financial disclosure?

Investigator, spouse and dependent children

What does a Class II device require for FDA notification?

FDA 510 (k) clearance

What is the purpose of MEDWATCH form 3500?

To report adverse events found in clinical care by healthcare professionals

What FDA regulations define in-vitro diagnostics?

21CFR 809.3 (a)

When does subject discontinuation require reporting to the FDA?

When discontinuation is d/t an adverse event or serious adverse event

What is FDA form 1572?

Statement of investigator

What is a specific reporting timeline for sponsors concerning serious and unexpected suspected adverse events?

15 calendar days

Who is responsible for ensuring investigators comply with GCP requirements?

The sponsor

How is an investigator defined per FDA regulations?

The individual who conducts the clinical investigation

What does the background information section of the protocol not require?

Details of the data safety monitoring board

What should investigators do to prevent accidental or premature destruction of essential study documents?

Prevent accidental/premature destruction

How many components are there in the summary information section of the FDA progress report for drug studies?

What does the summary information in the FDA progress report for drug studies typically include?

List of subjects who have died and subjects who dropped out d/t adverse events

How often must the IRB renew its registration?

Every 3 years

IVD studies don’t need informed consent if they meet which criteria?

If IDE submission unnecessary, leftover specimens used, investigators different from caregivers, and overseen by IRB among others

Which of the following is part of the CAPA process?

Identification of root cause of issues

What does CAPA stand for?

Corrective And Preventative Action

What is an additional document required during the trial for both investigator and sponsor?

IP accountability records

What should be included in the first section of the FDA progress report for drug studies?

Individual study information

What risk level does Class III devices present?

Significant Risk

How should an investigator reconcile investigational product received from the sponsor?

By reconciling the received product as per regulations

What Is reviewed during source data review (SDR) to ensure quality of a clinical trial?

Source documentation

During what time frame must financial interests be disclosed?

Course of the study + 1 yr after

What types of reports must be made from an investigator to a sponsor?

Safety occurrences, protocol deviations, progress reports, final reports, financial disclosures reports

Who ultimately approves an ICF?

IRB

What requirements does ICH GCP state for sponsors regarding IP accountability?

Ensuring timely delivery of IP to investigators, maintaining records of shipment, receipt, disposition, return and destruction, maintaining systems for retrieving and disposition of unused IP, ensuring IP stability, maintaining sufficient quantities of IP

How many days does a sponsor have to report withdrawal of IRB approval?

5 working days

Which federal regulations govern financial disclosure by researchers?

21 CFR 54

When does a facility receive a Warning Letter from the FDA?

When voluntary corrective action is needed

What items should be present in an investigators brochure?

Drug description, pharmacological effects, PK and biological disposition, safety and effectiveness, possible risks and side effects

Whose responsibility is it to ensure investigators and staff are trained?

CTM or CRA

When does subject discontinuation require reporting to the IRB?

If trial is greater than minimal risk and IRB requires notification

What form is used to communicat4e FDA audit findings?

FDA form 483

What is the medical device equivalent of an SAE?

Unanticipated adverse device effect (UADE)

What indicates the FDA found objectionable conditions that do require action?

OAI

Which is a commonly used section in protocols by sponsors that is not directly recommended by ICH GCP?

Table of contents

What information is needed from investigators prior to clinical trial participation?

Signed investigator agreement, CV, signed protocol, financial disclosure

According to 21 CRF Part 50, what is the definition of “ward” in the context of clinical investigations?

A "ward" is defined as a child placed in the legal custody of the State or another agency, institution, or entity, consistent with applicable laws.

Under what circumstances can a waiver of informed consent be granted for the use of an investigational drug in military personnel, as per 21 CFR Part 50?

A waiver may be granted by the President only if it is determined in writing that obtaining consent is not feasible, contrary to the best interests of the military member, or not in the interests of national security.

As per 21 CFR Part 50, what is the role of an IRB when determining parental permission for a child's participation in a clinical investigation?

The IRB must determine if the permission of one or both parents is necessary and ensure that adequate provisions are made for soliciting and documenting their permission.

What is the definition of an "application for research or marketing permit" according to 21 CFR Part 56?

It includes various submissions like a color additive petition, food additive petition, data for GRAS substances, and applications related to drug approvals and bioequivalence.

According to 21 CFR Part 312, what is required for a clinical investigation of a new drug to begin?

The investigation must be subject to an active IND (Investigational New Drug Application) filed with the FDA.

What are the three phases of a clinical investigation for a previously untested drug, as outlined in 21 CFR Part 312?

Phase 1 (initial human testing), Phase 2 (controlled trials for efficacy and side effects), and Phase 3 (large-scale trials for safety and effectiveness).

Describe the labeling requirements for an investigational new drug intended for human use, as per 21 CFR Part 312.

The immediate package must state, "Caution: New Drug—Limited by Federal (or United States) law to investigational use." The label cannot claim safety or effectiveness for the investigated purposes.

As per 21 CFR Part 812, what is the definition of a "significant risk device"?

A "significant risk device" is an investigational device that is either intended as an implant with a potential for serious risk or is represented as life-supporting/sustaining and presents a potential for serious risk to the subject's health, safety, or welfare.

Which of the following is a disclosure of financial interests form? A. 21 CFR 312 B. FDA 3500 C. Form 3454 D. FDA Form 3455

The form ___ is used for investigational new drugs (IND) A. 1571 B. 1572 C. 3500a D. 1583

Which of the following is 21 CFR 56.106 Subpart B? A. Certification B. Licensure C. FDA Form 3455 D. Registration

What is 21 CFR 50.27? A. Exception from general requirements B. Documentation of informed consent C. HHA- protection of human health subjects D. IRB review of research

________ means the party who submits a marketing application to FDA for approval of a drug device or biologic product. A. Contract Research Organization B. Authors Of Similar Models C. The Sponsor D. Clinical Investigator

What is the primary purpose of Good Clinical Practice (GCP) guidelines? A) To promote the standardization of clinical research across different countries. B) To ensure the safety and well-being of research participants and the integrity of clinical trial data. C) To accelerate the drug development process. D) To reduce the cost of clinical trials.

According to the Declaration of Helsinki, which of the following statements is true regarding the participation of vulnerable population in research? A. Vulnerable populations should not participate in research to avoid potential harm B. The participation of vulnerable population should be limited to non-invasive studies only C. Additional safeguards should be provided to protect the rights and welfare of vulnerable populations D. Vulnerable populations can participate in research without any additional considerations

Which of the following regulations governs the protection of human subjects in non-FDA-regulated research conducted in the United States? A. 21 US Code of Federal Regulations- Part 50 B. 21 US Code of Federal Regulations- Part 56 C. 45 US Code of Federal Regulations- Part 46 D. ICH GCP E6(R3)

Which document provided the ethical framework for the protection of human subjects in the US? A. The Nuremberg Code B. The Belmont Report C. The Declaration of Helsinki D. 21 US CFR- Part 50

Which international document provides guidelines for medical research involving human subjects? A. The Nuremberg Code B. The Belmont Report C. The Declaration of Helsinki D. ICH GCP E6(R3)

Which set of regulations governs the conduct of clinical trials in the US? A. 21 CFR 11 B. 21 CFR 312 C. 45 CFR46 D. 21 CFR 56

In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk? A. the clinical investigator B. a data safety monitoring board C. the reviewing IRB/IEC D. the medical monitor

After completion of a Phase III trial, which document should IRB/IEC retain? A. occupations and affiliation of IRB member D. sponsor/investigator contacts C. subject enrollment logs D. investigational product labels

A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard. Before applying this change to all subjects, what must occur? A. obtain IRB/IEC approval B. Inform all subjects C. train sub-investigators D. document change in study file

Why would a Phase IV study be conducted? a. different dosage b. different schedule of administration c. different off-label population d. different marketing strategy

What is included in the statement of investigator? a. a statement disclosing investigator financial interests b. a statement responding to FDA inspection observations c. a statement describing preclinical and human safety data d. a statement agreeing to comply with FDA regulations

In accordance with the ICH GCP guideline, at what intervals should the on-site study monitoring be performed? a. at least weekly b. every 4-6 weeks until study close-out c. in a timely manner before, during, and after the study d. once a year until study close-out

On May 15 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records? a. 16 May 2021 b. 15 May 2022 c. 16 May 2022 d. 15 May 2024

c FDA requires maintained records until AFTER 2 year period ends

According to the CFR, when children who are wards of the state enroll into a clinical trial, what is required? a. the IRB/IEC must include a member who advocated for the children b. each child must have a patient advocate c. assenting children must self-represent d. the investigator must represent the children

In accordance with the ICH GCP guidelines,, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions? a. institution administrator b. sponsor c. study coordinator d. IRB/IEC

Which of the following would be considered an addendum to an investigator's brochure for an unapproved investigational product? a. revisions to the risk section of the informed consent form b. a suspected unexpected serious adverse reaction (SUSAR) report c. a site-specific SAE report d. product monograph updates

A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for treatment of subjects with chronic arthritis" is an examples of a : a. phase 1 b. phase 2 c. phase 3 d. phase 4

b phase classification is based on study objective, not just subject numbers

Practice Test Flashcards

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