I85PREP
⌘ K
ACRP-MDP study materials
ACRP-MDP study resources

ACRP-MDP practice questions

One question at a time. Build your ACRP-MDP understanding.

First 50 of 199 questions. Each one lists the choices, the correct answer, and an explanation. The checker at the top of this page saves progress in this browser when it is available.

Continue in the practice tool above to load more questions, 50 at a time.

Question 1Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Under the ICH E6 Good Clinical Practice framework, which document constitutes the primary agreement between a sponsor and an investigational site defining responsibilities, obligations, and the scope of the trial?

  1. The monitoring plan
  2. The investigator's brochure
  3. The clinical trial agreement Correct answer.
  4. The case report form

Explanation

The clinical trial agreement (sometimes paired with a contract) is the formal written arrangement allocating obligations between sponsor and site. The investigator's brochure summarizes preclinical and clinical data, and the monitoring plan describes oversight activities, neither of which is the governing agreement.

Question 2Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A medical device trial enrolls subjects and collects data on device performance over time. Which term describes the systematic, independent examination of trial-related activities and documents to determine whether they were conducted according to the protocol, SOPs, GCP, and applicable regulations?

  1. Auditing Correct answer.
  2. Monitoring
  3. Inspection
  4. Verification

Explanation

Auditing is an independent, systematic examination of trial activities and documents, typically performed by an entity separate from the operational team. Monitoring is the ongoing sponsor oversight of the trial, and inspection is a regulatory authority's review of records.

Question 3Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

In a clinical investigation of a significant-risk device, a subject experiences a serious adverse event. Which party is generally responsible for promptly reporting the event to the sponsor and, where required, to the reviewing IRB?

  1. The contract research organization
  2. The device manufacturer's quality unit
  3. The principal investigator Correct answer.
  4. The sponsor's regulatory affairs department

Explanation

The investigator is responsible for reporting serious adverse events to the sponsor and, per IRB and regulatory requirements, to the reviewing IRB. The sponsor then fulfills its own regulatory reporting obligations to authorities.

Question 4Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A randomized, blinded investigation compares a novel wound-closure device with standard sutures. Which design element most directly reduces selection bias at the point of treatment assignment?

  1. Use of a placebo comparator
  2. Double data entry
  3. Allocation concealment Correct answer.
  4. Prospective registration

Explanation

Allocation concealment prevents investigators from knowing or influencing the next assignment, which protects the randomization sequence from selection bias. Blinding, data entry procedures, and registration address other sources of error.

Question 5Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor plans a pivotal investigation of a high-risk implantable device. Which document must be submitted to the reviewing IRB describing the device, its intended use, and the risks and benefits known from prior testing?

  1. The investigational device brochure Correct answer.
  2. The informed consent form
  3. The clinical investigation plan
  4. The monitoring report

Explanation

The investigational device brochure (or equivalent report of prior investigations) provides the IRB and investigators with information on the device, its intended use, and prior testing to support risk assessment. The investigation plan describes trial procedures, and the consent form communicates risks to subjects.

Question 6Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

During a monitoring visit, a monitor finds that several enrolled subjects did not meet a key inclusion criterion. What is the most appropriate immediate action?

  1. Exclude the subjects from the analysis without further documentation
  2. Re-enroll the affected subjects under a revised consent form
  3. Escalate the finding to the sponsor and document it, then determine subject disposition per the protocol Correct answer.
  4. Wait until database lock to assess whether the deviation affected results

Explanation

Protocol deviations involving eligibility must be documented and escalated so the sponsor and investigator can assess subject safety and trial integrity and decide on disposition. Retroactive or undocumented handling undermines data integrity and subject protections.

Question 7Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which element of informed consent is especially important for a trial involving a novel implantable device with limited long-term human data?

  1. A commitment to keep the subject blinded to all study information
  2. A statement that the subject waives all rights to compensation
  3. A guarantee of clinical benefit from the device
  4. A clear description of foreseeable risks, including unknown long-term risks Correct answer.

Explanation

Consent must describe foreseeable risks and make clear when long-term effects are unknown, allowing subjects to make an informed decision. Consent cannot waive legal rights or guarantee benefit.

Question 8Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A site's IRB approves a protocol amendment that changes the primary endpoint. Which action is required before implementing the change at the site?

  1. Notify only the sponsor and proceed
  2. Apply the change only to newly enrolled subjects without documentation
  3. Implement immediately and notify the IRB afterward
  4. Obtain IRB approval and, where applicable, regulatory authorization before implementation Correct answer.

Explanation

Changes affecting subject rights, safety, or welfare generally require IRB review and approval, and regulatory authorization where applicable, before implementation except to eliminate immediate hazards. Documentation and approval precede implementation.

Question 9Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which source document characteristic is essential to support the reliability of data entered into a case report form during a device trial?

  1. It is maintained by the monitor rather than the site
  2. It is stored only in the sponsor's electronic system
  3. It is attributable, legible, contemporaneous, original, and accurate Correct answer.
  4. It is summarized from subject interviews at the end of the trial

Explanation

Source data must meet the ALCOA principles-attributable, legible, contemporaneous, original, and accurate-so that reported data can be verified. Sponsor-only storage, retrospective summaries, or monitor-maintained records do not satisfy this requirement.

Question 10Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor is evaluating whether an investigation of a new diagnostic device poses significant risk. Which factor is most relevant to that determination?

  1. The number of sites participating in the investigation
  2. Whether the device is intended as a surrogate for an established diagnostic
  3. The size of the sponsor company
  4. Whether the device is invasive and presents a potential for serious risk to subject health Correct answer.

Explanation

Significant-risk determinations hinge on the device's invasiveness and the potential for serious risk to subjects' health, safety, or welfare. Logistical factors such as site count or company size are irrelevant to the risk classification.

Question 11Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

What is the primary purpose of the sponsor's oversight of a medical device clinical investigation?

  1. To ensure subject rights, safety, and data integrity throughout the trial Correct answer.
  2. To guarantee that the device will receive marketing authorization
  3. To eliminate the need for IRB review at participating sites
  4. To replace the investigator's responsibility for trial conduct

Explanation

Sponsor oversight exists to protect subject rights and safety and to ensure data integrity and regulatory compliance. It does not guarantee approval, replace investigator duties, or eliminate IRB review.

Question 12Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

An investigator delegates informed consent discussions to a sub-investigator. Which documentation best supports this delegation?

  1. An email from the coordinator confirming verbal agreement
  2. The protocol's general statement that tasks may be delegated
  3. A delegation log listing the delegated task and the individual's qualifications Correct answer.
  4. A note in the subject's chart after consent is obtained

Explanation

Delegation of trial-related duties should be documented in a delegation log that identifies the task and the individual's qualifications, with appropriate training records. Verbal or informal arrangements do not provide adequate documentation.

Question 13Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which statement best describes the role of an independent data monitoring committee in a device investigation?

  1. It reviews accumulating safety and efficacy data and recommends whether the trial should continue Correct answer.
  2. It prepares the case report forms for data entry
  3. It negotiates clinical trial agreements with sites
  4. It performs source data verification at participating sites

Explanation

An independent data monitoring committee reviews accumulating data and advises on trial continuation, modification, or termination to protect subjects. Source verification, contracting, and CRF design are separate functions.

Question 14Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A monitor identifies that a site has been using an outdated version of the informed consent form for two newly enrolled subjects. What is the most appropriate corrective action?

  1. Re-consent the affected subjects with the current approved form and document the deviation Correct answer.
  2. Discard the outdated forms without notifying the sponsor
  3. Transfer the affected subjects to another site
  4. Continue using the outdated form until it runs out

Explanation

Subjects should be re-consented with the currently approved form, and the deviation should be documented and reported per applicable requirements. Continuing with or concealing the outdated form would compound the deviation.

Question 15Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which activity is a core component of source data verification during monitoring?

  1. Comparing case report form entries against original source records Correct answer.
  2. Recalculating the sponsor's budget for the trial
  3. Reviewing the device manufacturer's marketing materials
  4. Confirming the investigator's publication plan

Explanation

Source data verification compares reported data with original source records to confirm accuracy and completeness. Budget, marketing, and publication activities are outside the scope of data verification.

Question 16Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A trial protocol specifies that the device must be stored at controlled room temperature. During a monitoring visit, the site's temperature logs show several excursions above the specified range. What is the most appropriate first step?

  1. Assume the device remains effective and continue enrollment
  2. Discard the device logs to avoid a deviation finding
  3. Document the excursions, assess impact on device integrity and subject safety, and notify the sponsor Correct answer.
  4. Adjust the protocol temperature range retroactively

Explanation

Temperature excursions must be documented, their impact assessed, and the sponsor notified so that appropriate actions (such as device quarantine or protocol deviation reporting) can be taken. Ignoring or altering records is unacceptable.

Question 17Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best describes the purpose of an investigator's agreement or FDA Form 1572-equivalent documentation in a device study?

  1. To certify that the device is safe for marketing
  2. To transfer all trial responsibilities from the investigator to the sponsor
  3. To replace the informed consent document
  4. To document the investigator's commitment to conduct the study per the protocol and applicable regulations Correct answer.

Explanation

Investigator agreements document the investigator's commitment to conduct the investigation in accordance with the protocol and regulations. They do not transfer responsibilities to the sponsor or certify marketing safety.

Question 18Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor wants to ensure that the statistical analysis plan is finalized before unblinding. Why is this timing important?

  1. It guarantees statistical significance
  2. It eliminates the need to report adverse events
  3. It allows the analysis methods to be adjusted after seeing the results
  4. It prevents post hoc selection of analyses that could bias conclusions Correct answer.

Explanation

Finalizing the analysis plan before unblinding preserves the integrity of the analysis by preventing data-driven changes that could bias conclusions. It does not guarantee significance or affect safety reporting obligations.

Question 19Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which action best supports the rights of a subject who wishes to withdraw from a device investigation?

  1. Continue collecting data from the subject without consent
  2. Require the subject to complete all remaining visits
  3. Withhold the subject's medical records from the subject
  4. Explain the consequences of withdrawal and allow the subject to stop participation without penalty Correct answer.

Explanation

Subjects may withdraw at any time without penalty, and the investigator should explain consequences and clarify which data may still be used per consent. Coercing continued participation or continuing data collection violates subject rights.

Question 20Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

An investigation uses a device that delivers a novel therapy. The sponsor learns of a new finding from an animal study suggesting a previously unknown risk. What is the most appropriate action?

  1. Withhold the information to avoid alarming subjects
  2. Promptly evaluate the finding and communicate updated risk information to investigators and the IRB as required Correct answer.
  3. Publish the finding only after trial completion
  4. Wait until the next scheduled protocol amendment cycle

Explanation

New and significant risk information must be evaluated and communicated promptly to investigators and the IRB so that consent and subject protections can be updated. Withholding such information or delaying communication is inappropriate.

Question 21Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is the most appropriate way to handle a protocol deviation that does not affect subject safety or data integrity?

  1. Automatically terminate the subject from the trial
  2. Report it only if the sponsor asks
  3. Document it and assess whether reporting to the IRB or sponsor is required Correct answer.
  4. Ignore it because it is insignificant

Explanation

All deviations should be documented and assessed against reporting criteria; even minor deviations may require notification depending on the protocol and IRB policies. Ignoring or selectively reporting them undermines oversight.

Question 22Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best characterizes the role of the IRB in a multicenter device investigation?

  1. It conducts source data verification at each site
  2. It negotiates the sponsor's budget with sites
  3. It manufactures and distributes the investigational device
  4. It reviews and oversees the ethical conduct of the research to protect subjects Correct answer.

Explanation

The IRB reviews and oversees research to protect the rights and welfare of subjects. Source verification, device distribution, and budget negotiation are separate functions.

Question 23Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor is designing a trial for a device intended to treat a condition for which no effective therapy exists. Which design consideration most directly addresses the ethical tension of using a control group?

  1. Selecting a control that reflects the current standard of care or, where none exists, an appropriate alternative Correct answer.
  2. Eliminating all safety monitoring to simplify the trial
  3. Using a historical control drawn from a different population
  4. Increasing the sample size without changing the control

Explanation

Control selection must reflect the current standard of care or an ethically appropriate alternative when none exists, balancing scientific validity with subject welfare. Historical controls from different populations may introduce bias, and reducing safety monitoring is never acceptable.

Question 24Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which record is most important for demonstrating device accountability throughout a clinical investigation?

  1. The sponsor's marketing plan
  2. The investigator's curriculum vitae
  3. The subject's insurance records
  4. The device shipment, receipt, use, and disposition log Correct answer.

Explanation

Device accountability records track shipment, receipt, use, return, or disposal to ensure the investigational device is controlled and documented. CVs, insurance records, and marketing plans do not serve this purpose.

Question 25Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A monitor notes that a site's consent documents are signed but lack the date of signature by the subject. What is the most appropriate interpretation and action?

  1. The sponsor should alter the consent form to remove the date field
  2. The missing date is a documentation deficiency that should be addressed and documented Correct answer.
  3. The consent is valid because a signature is present
  4. The subject should be withdrawn immediately without discussion

Explanation

A missing signature date is a documentation deficiency that should be identified, documented, and corrected per site procedures to confirm consent preceded trial procedures. It does not automatically invalidate consent or require immediate withdrawal.

Question 26Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which document serves as the primary reference for the design, conduct, and reporting of a medical device clinical investigation?

  1. The clinical investigation plan Correct answer.
  2. The case report form
  3. The informed consent form
  4. The investigator's brochure

Explanation

The clinical investigation plan (CIP), also known as the protocol, is the core document that specifies the objectives, design, methodology, statistical considerations, and organization of a trial. It guides all aspects of study conduct and reporting.

Question 27Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which principle of Good Clinical Practice (GCP) is most directly supported by obtaining informed consent from each subject before any study-related procedures?

  1. Justice
  2. Respect for persons Correct answer.
  3. Scientific validity
  4. Beneficence

Explanation

Respect for persons requires that individuals be treated as autonomous agents and that those with diminished autonomy be protected. Obtaining informed consent ensures that subjects voluntarily agree to participate, thereby upholding this principle.

Question 28Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

During a clinical investigation, a subject experiences an adverse event that is serious and unexpected and for which the investigational device is a suspect cause. What is the sponsor's primary reporting obligation?

  1. Report the event to the IRB at the site within 24 hours.
  2. Notify the FDA and all participating investigators in an expedited manner. Correct answer.
  3. Document the event in the annual report only.
  4. Inform the subject's primary care physician and take no further action.

Explanation

Serious and unexpected adverse device effects that are suspected to be caused by the device must be reported to the FDA and all participating investigators in an expedited safety report. This allows timely assessment of risks across all sites.

Question 29Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best describes the purpose of a device accountability log in a clinical investigation?

  1. To track the receipt, use, and disposition of the investigational device Correct answer.
  2. To document the training of site staff on device use
  3. To record subject compliance with the dosing regimen
  4. To list the calibration records for the device

Explanation

A device accountability log is used to document the chain of custody and ensure that the investigational device is used only by authorized personnel and only for the approved number of subjects. It records receipt, dispensing, return, and destruction of devices.

Question 30Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

An investigator plans to make a change to the clinical investigation plan to eliminate an immediate hazard to subjects. What is the appropriate action?

  1. Wait for IRB approval before implementing the change.
  2. Implement the change immediately and report it to the IRB within 5 working days. Correct answer.
  3. Implement the change and notify the FDA within 30 days.
  4. Implement the change only after obtaining sponsor approval.

Explanation

When a change is necessary to eliminate an immediate hazard to subjects, the investigator may implement the deviation without prior IRB approval. However, the IRB must be notified promptly, typically within 5 working days, and the change should be documented.

Question 31Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a key responsibility of the sponsor in a medical device clinical investigation?

  1. Selecting qualified investigators and ensuring proper monitoring Correct answer.
  2. Obtaining informed consent from each subject
  3. Reporting adverse events to the IRB at each site
  4. Performing the statistical analysis personally

Explanation

The sponsor is responsible for selecting qualified investigators, providing them with the necessary information and training, and ensuring that the investigation is properly monitored. These activities help ensure subject safety and data integrity.

Question 32Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

During a monitoring visit, a monitor discovers that a subject's informed consent was obtained after the subject underwent a study-related MRI. What is the most appropriate classification of this event?

  1. A major protocol deviation Correct answer.
  2. A minor protocol deviation
  3. An adverse event
  4. A serious adverse event

Explanation

Obtaining consent after a study procedure violates the fundamental right of a subject to give informed consent before any study-related activities. This is considered a major protocol deviation because it compromises subject rights and welfare.

Question 33Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is an essential element of the informed consent form for a clinical investigation of a medical device?

  1. A statement that the device has been approved by the FDA for the indication under study
  2. A guarantee that the subject will receive the investigational device if it proves effective
  3. A description of the reasonably foreseeable risks or discomforts Correct answer.
  4. The financial disclosure of the investigator

Explanation

Informed consent must include a description of any reasonably foreseeable risks or discomforts to the subject. This allows the subject to make an informed decision about participation.

Question 34Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor is planning a clinical investigation of a new device. Which factor is most important in determining whether the investigation is exempt from the IDE regulations?

  1. The device is a non-significant risk device. Correct answer.
  2. The device is a significant risk device.
  3. The device is intended for a life-threatening condition.
  4. The investigation involves a placebo control.

Explanation

Investigations of non-significant risk devices are exempt from the IDE regulations, provided they comply with the abbreviated requirements. Significant risk devices require an approved IDE.

Question 35Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best describes the role of the IRB in a multicenter device investigation?

  1. The IRB at each site must review and approve the study. Correct answer.
  2. A single central IRB can review and approve the study for all sites.
  3. The sponsor's IRB reviews and approves the study for all sites.
  4. The FDA serves as the IRB for multicenter studies.

Explanation

Each institution engaged in research involving human subjects must have an IRB review and approve the research. While central IRBs are increasingly used, local IRB review is still required unless a central IRB is designated.

Question 36Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a key component of the investigator's brochure for a medical device?

  1. A summary of preclinical and clinical data relevant to the device Correct answer.
  2. The informed consent form template
  3. A list of all adverse events reported for the device
  4. The statistical analysis plan for the proposed study

Explanation

The investigator's brochure provides a summary of preclinical and clinical data, including device description, instructions for use, and safety information. It is intended to inform investigators about the device and support their conduct of the study.

Question 37Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A subject enrolled in a device trial becomes pregnant. Which action should the investigator take first?

  1. Immediately withdraw the subject from the trial.
  2. Perform an ultrasound to determine fetal health.
  3. Continue the subject in the trial without modification.
  4. Report the pregnancy to the sponsor and IRB as per protocol. Correct answer.

Explanation

Pregnancy itself is not typically an adverse event, but it must be reported to the sponsor and IRB according to the protocol and regulatory requirements. The subject's continued participation should be evaluated based on the protocol and risks.

Question 38Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is an example of source data in a device clinical investigation?

  1. The case report form
  2. The statistical analysis report
  3. The electronic data capture system
  4. The subject's medical records Correct answer.

Explanation

Source data are all information in original records and certified copies of original records of clinical findings, observations, or other activities necessary for the reconstruction and evaluation of the trial. The subject's medical records are a primary source.

Question 39Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

During a monitoring visit, a monitor finds that the site's device accountability log has missing entries for several devices. What is the most appropriate action for the monitor to take?

  1. Document the finding and discuss it with the site to implement corrective actions. Correct answer.
  2. Remove the log from the site to prevent further errors.
  3. Immediately report the site to the FDA for misconduct.
  4. Ignore the issue because it is a minor administrative matter.

Explanation

The monitor should document the finding and discuss it with the site to ensure corrective and preventive actions are implemented. This helps maintain device accountability and data integrity.

Question 40Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a characteristic of a significant risk device study?

  1. It does not require IRB approval.
  2. It requires an approved IDE before initiation. Correct answer.
  3. It can be conducted without informed consent.
  4. It is exempt from IDE regulations.

Explanation

A significant risk device study requires an approved IDE from the FDA before it can begin. This ensures that the risks to subjects are carefully evaluated and that the study is conducted safely.

Question 41Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor is considering using a central IRB for a multicenter device study. Which of the following is a key consideration?

  1. Central IRB review is only allowed for minimal risk studies.
  2. Each participating site must agree to rely on the central IRB. Correct answer.
  3. Central IRB review eliminates the need for site-specific informed consent forms.
  4. The central IRB must be located in the same state as the sponsor.

Explanation

When using a central IRB, each participating site must agree to rely on that IRB for review. This agreement is essential to ensure that the central IRB has authority over the research at each site.

Question 42Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best describes the purpose of the FDA's investigational device exemption (IDE) regulations?

  1. To allow investigational devices to be used in clinical studies to collect safety and effectiveness data Correct answer.
  2. To require that devices be tested only in animals before human use
  3. To ensure that all medical devices are approved before marketing
  4. To exempt all devices from regulatory oversight during clinical trials

Explanation

The IDE regulations allow an investigational device to be used in a clinical study to collect safety and effectiveness data, while ensuring that subjects are protected and that the study is scientifically sound.

Question 43Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A monitor is reviewing a site's regulatory binder and finds that the investigator's CV is outdated. What is the most appropriate action?

  1. Note the finding in the monitoring report only.
  2. Inform the FDA immediately.
  3. Remove the CV from the binder.
  4. Request an updated CV from the investigator. Correct answer.

Explanation

The regulatory binder must contain current documentation, including an up-to-date CV for the investigator. The monitor should request an updated CV to ensure compliance with regulatory requirements.

Question 44Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a key element of the clinical investigation plan (CIP) for a device study?

  1. The statistical analysis plan Correct answer.
  2. The device's marketing brochure
  3. The investigator's financial disclosure
  4. The informed consent form

Explanation

The CIP must include a statistical analysis plan that describes the methods for analyzing the data. This ensures that the study is designed to provide valid answers to the research questions.

Question 45Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A subject in a device trial experiences an adverse event. The investigator determines that the event is related to the device. What is the investigator's responsibility regarding reporting?

  1. Wait until the annual report to report the event.
  2. Report the event only to the subject's primary care physician.
  3. Report the event to the sponsor and IRB according to the protocol and regulations. Correct answer.
  4. Take no action because the event is related to the device.

Explanation

The investigator must report adverse events to the sponsor and the IRB according to the protocol and applicable regulations. This includes reporting the event in a timely manner and documenting it appropriately.

Question 46Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a potential consequence of failing to obtain informed consent before a subject undergoes a study-related procedure?

  1. The study data may be considered unreliable and subject to regulatory action. Correct answer.
  2. The sponsor may be required to withdraw the device from the market.
  3. The subject may be required to pay for the procedure.
  4. The investigator may be required to repeat the procedure.

Explanation

Obtaining consent after a study procedure is a serious violation of subject rights and can lead to regulatory action, including invalidation of data and sanctions against the investigator. It compromises the integrity of the study.

Question 47Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following is a key responsibility of the investigator in a medical device clinical investigation?

  1. Obtaining FDA approval for the device
  2. Designing the statistical analysis plan
  3. Ensuring that the study is conducted according to the protocol Correct answer.
  4. Monitoring the study at other sites

Explanation

The investigator is responsible for conducting the study according to the protocol and applicable regulations. This includes ensuring that the rights, safety, and welfare of subjects are protected and that the data are accurate and reliable.

Question 48Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

A sponsor is evaluating whether a device study poses significant risk. Which factor is most relevant to this determination?

  1. The study is conducted at a single site.
  2. The study involves a placebo control.
  3. The device is intended for a condition that is not life-threatening.
  4. The device is implanted and may pose a potential for serious harm. Correct answer.

Explanation

The determination of significant risk considers whether the device is an implant, whether it is intended to support or sustain life, and whether it presents a potential for serious risk to the health, safety, or welfare of a subject. An implanted device that may cause serious harm is likely to be significant risk.

Question 49Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

Which of the following best describes the purpose of the FDA's requirement for financial disclosure by clinical investigators?

  1. To ensure that investigators are paid fairly
  2. To determine the budget for the clinical trial
  3. To identify potential conflicts of interest that could affect the study's integrity Correct answer.
  4. To verify the investigator's qualifications

Explanation

Financial disclosure is required to identify any financial interests that could bias the conduct or reporting of the study. This helps ensure the integrity of the data and protect the public health.

Question 50Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline)

During a clinical investigation, a subject decides to withdraw from the study. What is the investigator's primary responsibility?

  1. Encourage the subject to continue for the sake of the study.
  2. Withdraw the subject from all future studies.
  3. Ensure the subject's decision is respected and document the withdrawal. Correct answer.
  4. Report the subject to the IRB for noncompliance.

Explanation

Subjects have the right to withdraw from a study at any time without penalty. The investigator must respect this decision and document the withdrawal according to the protocol and regulations.