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ACRP ACRP-CP Dumps

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Total 125 questions

ACRP Certified Professional Exam Questions and Answers

Question 1

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

Options:

A.

A total of five members.

B.

One member whose primary area of interest is in the same scientific area.

C.

One member of the site's QA group.

D.

One member who is independent of the institution/trial site.

Question 2

Who is responsible for the ongoing safety evaluation of the IP?

Options:

A.

Regulatory agency

B.

IRB/IEC

C.

Sponsor

D.

PI

Question 3

A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year, 150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

Options:

A.

Re-train investigators on recruitment obligations.

B.

Allocate additional monitoring resources to the trial.

C.

Reduce the target sample size based on feedback from the sites.

D.

Evaluate the screen failures to determine if the protocol needs revision.

Question 4

A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

Options:

A.

Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.

B.

Report this incident immediately to the sponsor and leave the treatment decision to them.

C.

Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.

D.

Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.

Question 5

The PI may assign responsibility for IP accountability to the pharmacist provided they are:

Options:

A.

Under the supervision of the PI.

B.

Licensed to practice medicine.

C.

An employee of the institution.

D.

Approved by the IRB/IEC.

Question 6

A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

Options:

A.

Original

B.

Complete

C.

Attributable

D.

Contemporaneous

Question 7

All site financial matters pertaining to a trial are listed in what document?

Options:

A.

Signed contract

B.

Financial disclosure

C.

Informed consent form

D.

Protocol

Question 8

The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

Options:

A.

Schedule participant for early termination visit.

B.

Inform participant and assure proper care is provided.

C.

Inform the monitor of the termination of the study.

D.

Inform the IRB/IEC of the study closure.

Question 9

Which of the following activities is the MOST efficient way of overseeing a CRO’s management during a clinical trial?

Options:

A.

Pre-qualification assessment of CRO

B.

Co-monitoring of CRO site visits

C.

Central monitoring of data fields by sponsor

D.

Risk-based audits of CRO activities as delegated

Question 10

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

Options:

A.

CRO

B.

Subject

C.

PI

D.

Sponsor

Question 11

In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

Options:

A.

PI

B.

IRB/IEC

C.

CRA

D.

CRC

Question 12

During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

Options:

A.

Evaluate study data.

B.

Conduct safety analysis.

C.

Validate protocol endpoints.

D.

Verify compliance with IP regimen.

Question 13

After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

Options:

A.

No approval is necessary: give the diary to each subject.

B.

Submit the diary to the sponsor for approval.

C.

Submit the diary to the regulatory authority for approval.

D.

Submit the diary to the IRB/IEC for approval.

Question 14

An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

Options:

A.

Sponsor

B.

PI

C.

IRB/IEC

D.

DSMB/IDMC

Question 15

A root cause analysis should be:

Options:

A.

Specific to a clinical trial.

B.

Written by the investigator.

C.

Validated before use in a CAPA.

D.

Focused on issues of non-compliance.

Question 16

Source data/documentation should be:

Options:

A.

Attributable, legible, contemporaneous, original, accurate, and complete.

B.

Attributable, legible, contemporaneous, original, accurate, and clear.

C.

Attributable, legible, correct, original, accurate, and complete.

D.

Attributable, legible, correct, original, accurate, and clear.

Question 17

Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

Options:

A.

CRC

B.

Sponsor

C.

CRA

D.

PI

Question 18

The inclusion and exclusion criteria are in place so all subjects are:

Options:

A.

Healthy and willing to complete the clinical trial.

B.

Patients with the disease under study and will not have any adverse events.

C.

Medically appropriate and protected from ethical vulnerability.

D.

Ethically vulnerable and patients with the disease under study.

Question 19

Which of the following elements of the Informed Consent are NOT required?

Options:

A.

A description of any reasonably foreseeable risks or discomforts

B.

Statement that study involves research

C.

A description of potential benefits

D.

Subject legal rights can be waived

Question 20

Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

Options:

A.

Consult the IB.

B.

Call the medical monitor.

C.

Administer rescue medication.

D.

Report the AE to the sponsor.

Question 21

Which document confirms the PI’s agreement to permit auditing at the study site?

Options:

A.

IB

B.

ICF

C.

Protocol

D.

Delegation Log

Question 22

The investigator/institution should permit:

Options:

A.

Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.

B.

Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).

C.

Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.

D.

Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

Question 23

A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.

Which of the following is an appropriate title for this study?

Options:

A.

A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

B.

A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population

C.

A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population

D.

A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population

Question 24

A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

Options:

A.

IB

B.

ICF

C.

Protocol

D.

Package insert

Question 25

While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

Options:

A.

Interview participants who have dropped out.

B.

Require participants to provide documented reason for withdrawal.

C.

Submit revised ICFs to the IRB/IEC with increased compensation for participants.

D.

Meet with the site staff to understand their workflows and to review retention strategies.

Question 26

During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:

An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.

The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety. The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.

What is the most appropriate next step the sponsor should take?

Options:

A.

Immediately unblind the entire trial to ensure patient safety.

B.

Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

C.

Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.

D.

Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.

Question 27

An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

Options:

A.

Executive board members.

B.

Independent qualified individuals.

C.

Regulatory authority expert advisors.

D.

Investigators participating in the trial.

Question 28

After the completion or termination of a clinical trial, who should store the enrollment log?

Options:

A.

PI

B.

CRO

C.

Sponsor

D.

Regulatory authority

Question 29

A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

Options:

A.

Location of stored trial records

B.

Availability of qualified staff to conduct the trial

C.

Information to be included in the advertising flyer

D.

Length of time to receive the approved trial device

Question 30

Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

Options:

A.

The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.

B.

The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.

C.

The CRC is responsible for identifying the relationship of an SAE to the IP.

D.

The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

Question 31

Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

Options:

A.

How does the risk of developing cancer compare to the anticipated side effects from the drug?

B.

How effective is the drug at treating patients that have been previously diagnosed with cancer?

C.

How willing are current patients to participate in a trial with potentially serious side effects?

D.

How likely are patients at high risk of cancer going to develop cancer during the study?

Question 32

The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

Options:

A.

Confirm subjects receive the appropriate reimbursement.

B.

Review the content for ethically or morally sensitive issues.

C.

Assure the ads do not impinge on confidentiality agreements.

D.

Safeguard the rights, safety, and well-being of all potential subjects.

Question 33

A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

Options:

A.

Redact subject identification for privacy protection.

B.

Deny the request until the sponsor approves.

C.

Allow access to the entire records.

D.

Consult with the IRB/IEC first.

Question 34

A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

Options:

A.

The number of users with access was not defined.

B.

The number of unique eCRF templates was not specified.

C.

The list of comparable technology solutions was not included.

D.

The frequency of data backup was not defined.

Question 35

Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

Options:

A.

1.8 mg/dL

B.

2.6 mg/dL

C.

3.0 mg/dL

D.

3.6 mg/dL

Question 36

An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

Options:

A.

Study sponsor

B.

Regulatory authority

C.

Investigator at each site

D.

Original reporting investigator

Question 37

A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

Options:

A.

Draft a CAPA plan

B.

Establish a DSMB/IDMC

C.

Develop a monitoring plan

D.

Conduct routine investigators' meetings

Page: 1 / 13
Total 125 questions