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ACRP-CCRC : ACRP Certified Clinical Research Coordinator Exam

Nursing ACRP-CCRC Questions & Answers

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ACRP-CCRC


ACRP Certified Clinical Research Coordinator


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Question: 901



cument the non-compliance and dismiss the subject from the study mediately report the subject to the ethics committee

view the medication adherence with the subject and document the discussion ange the protocol to accommodate the subject's needs


er: C


nation: It is crucial to review and document the subject's adherence and reasons for non-com han dismissing them or altering the protocol without justification.


ion: 902


is tasked with overseeing the blinding procedures of a clinical trial. What is the most impo to ensure blinding is maintained throughout the study?


nduct regular training for all staff involved in the trial.

ure that the investigational product is labeled in a way that prevents identification. ow investigators to have access to unblinded data during the trial.

ange the treatment assignments mid-study if necessary. er: B

nation: Proper labeling of the investigational product to prevent identification is essential for ining the integrity of the blinding throughout the study.

During a subject visit, you find that the subject has not adhered to the medication schedule as stated in the protocol. What steps should you take to assess and document the subject’s compliance effectively?


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Question: 903


In a clinical trial for a new antidepressant, participants are dropping out at a higher rate than expected. Upon investigation, the coordinator finds that many participants are unaware of the potential side effects. What is the best strategy to address this issue?


  1. Increase the frequency of follow-up calls to participants

  2. Update the informed consent document to include more detailed information

  3. Organize a group meeting to discuss side effects in detail

  4. Provide individual counseling sessions about the medication's risks Answer: B

Explanation: Updating the informed consent document to include detailed information about potential side effects ensures that all participants are adequately informed about the risks of the study.


Question: 904


ined accurately. If you discover that a log entry was made incorrectly, what should be your diate action?


se the incorrect entry and replace it with the correct information. orm the monitor but do nothing to correct it.

ore the mistake as it is a minor issue.

cument the error, provide the correct information, and follow the proper protocol for correcti


er: D


nation: Documenting the error and providing the correct information according to protocol en iance with regulatory requirements and maintains data integrity.


ion: 905


vestigational product shipment arrives at your site, but the shipment box is damaged. What is diate course of action regarding the investigational product inside?


cept the shipment without further inspection mediately reject the shipment without inspection

en the box and inspect the product for damage before acceptance tify the sponsor and wait for instructions


er: C

As the clinical research coordinator, you are tasked with ensuring that all study-related logs are mainta

imme


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Explanation: It is essential to inspect the product for damage before acceptance to ensure its integrity and compliance with handling requirements.


Question: 906


In a study examining a new cancer treatment, a clinical research coordinator must ensure that all study- related documents are accessible to authorized personnel only. What is the most appropriate way to safeguard this information?

  1. Store all documents in a locked filing cabinet

  2. Distribute printed copies of documents to all study team members

  3. Use a password-protected electronic database with limited access

  4. Rely on verbal communication to share sensitive information Answer: C

Explanation: Using a password-protected electronic database with limited access is the most secure way to protect sensitive study-related documents, ensuring that only authorized personnel can view them.



re auditing the storage conditions of an investigational product that requires specific environ ls. If you find that the humidity levels exceed 60% for an extended period, what should your e?


cument the findings, adjust controls, and inform the sponsor ore the humidity levels as they are within acceptable limits card the investigational product immediately

it for the next scheduled audit to address the issue er: A

nation: Documenting the findings, adjusting controls, and informing the sponsor ensures iance and addresses potential risks to the investigational product's integrity.


ion: 908


valuating the feasibility of a study site to conduct a clinical trial, which of the following fa st relevant to this assessment?


ailability of qualified staff

vious experience with similar studies geographical location of the site

number of patients enrolled in the last trial conducted

Question: 907


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Explanation: While location can affect recruitment, it is less relevant than staff qualifications, experience, and previous trial outcomes when assessing the site's overall feasibility.


Question: 909


A clinical trial is assessing the long-term effects of a new anti-inflammatory drug. The IRB has requested interim results before granting further approval. How should the study coordinator prepare the report?

  1. Summarize the data without detailed analysis

  2. Include a comprehensive analysis of interim data and safety outcomes

  3. Provide raw data for the IRB to analyze

  4. Only report positive outcomes to the IRB Answer: B

Explanation: A comprehensive analysis of interim data and safety outcomes is necessary for the IRB to make informed decisions regarding the study's continuation.



re overseeing the collection of urine samples for a clinical trial. If a participant's urine sampl ed at 8:00 AM, what is the latest time it should be processed to ensure compliance with pro


AM 00 AM

00 AM

00 PM


er: B


nation: The latest time for processing the urine sample should be 10:00 AM, assuming the pr es a 2-hour window from collection.


ion: 911


a subject's visit, it is discovered that they have not been following the protocol for medicati specifically missing doses. What is the recommended method for assessing their overall iance with the study protocol?


view the subject’s medication calendar and discuss it with them ume all subjects are compliant unless otherwise reported

nduct a follow-up visit to observe the subject taking their medication er the subject to a psychologist for adherence counseling

Question: 910


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Explanation: Reviewing the medication calendar with the subject will help assess their overall compliance and identify any barriers to adherence.

Question: 912


What is the rationale for complying with a protocol in a clinical trial?


  1. To ensure accurate and reliable data collection

  2. To minimize the number of subjects needed for the study

  3. To expedite the approval process by regulatory authorities


    wer: A


    anation: The rationale for complying with a protocol in a clinical trial re accurate and reliable data collection. By following the protocol, rchers can maintain consistency in the study procedures and ensure th ata collected is valid and can be analyzed effectively. Options B, C, a ot the primary reasons for protocol compliance and do not directly rel uality of data collection. Therefore, option A is the correct answer.


    stion: 913


    When determining subject eligibility for a clinical trial, which of the follo rs should be taken into consideration?


    ubject's age and gender

    ubject's medical history and pre-existing conditions ubject's availability for clinic visits

    To reduce the overall cost of the clinical trial Ans

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ensu

resea at

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facto


  1. S

  2. S

  3. S

  4. Subject's willingness to comply with study procedures Answer: B

wing

Explanation: When determining subject eligibility for a clinical trial, factors such as the subject's medical history and pre-existing conditions are important considerations. These factors help ensure that the subjects meet the specific

eligibility criteria defined in the trial protocol. Options A, C, and D may also be relevant in certain cases, but they are not as essential as the subject's medical history and pre-existing conditions when determining eligibility. Therefore, option B is the correct answer.


Question: 914


ple size in a clinical trial?


ower analysis value calculation

onfidence interval estimation ype I error control


wer: A


anation: The statistical principle related to determining the sample siz cal trial is power analysis. Power analysis helps researchers determine opriate sample size needed to detect a statistically significant effect if within the population being studied. Options B, C, and D are also rtant statistical principles but are not specifically related to determini

ample size. Therefore, option A is the correct answer.


stion: 915

Which of the following statistical principles is related to determining the sam


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Which of the following elements is typically included in an Investigational Brochure (IB) or investigational device use documentation?


  1. Study population demographics and characteristics

  2. Informed consent process and documentation

  3. Adverse event reporting procedures

  4. Subject eligibility criteria

Answer: C


fically related to the IB or investigational device use documentation. efore, option C is the correct answer.


stion: 916


linical trial, what is the rationale for using a lemental/rescue/comparator product in the study design?


enhance the effectiveness of the investigational product

evaluate the safety and efficacy of the investigational product relati omparator product

reduce the overall cost of the clinical trial simplify the study procedures for the subjects


wer: B


anation: The rationale for using a supplemental/rescue/comparator pro linical trial is to evaluate the safety and efficacy of the investigationa

Explanation: An Investigational Brochure (IB) or investigational device use documentation typically includes information about adverse event reporting procedures. This is important for ensuring the safety of the subjects participating in the clinical trial. Options A, B, and D may be important components of the trial protocol or informed consent process but are not speci

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product relative to the comparator product. This allows researchers to assess the effectiveness of the investigational product compared to an established standard or reference treatment. Options A, C, and D do not capture the primary purpose of using a supplemental/rescue/comparator product in the study design. Therefore, option B is the correct answer.


Question: 917

A summary of the pharmacokinetics and biological transformation and disposition of the investigational product in all species studied should be given. The discussion of the findings should address the absorption and the local and systemic bioavailability of the investigational product and its metabolites, and their relationship to the pharmacological and toxicological findings in animal species.


6(R1) 4.8.10 Both the informed consent discussion and the written med consent form and any other written information to be provided to ects should include explanations of. . .Part 1

6(R1) 8.3.8 -- Documentation of Investigational Products and Trial-Re rials Shipment

6(R1) 7.3.5 -- Nonclinical studies: Introduction -- Pharmacokinetics a uct Metabolism in Animals

6(R1) 3.3.7


wer: C


anation: This question is asking about a specific requirement related t ussion of pharmacokinetics and product metabolism in animals during linical studies. The correct answer can be found in section E6(R1) 7.3 uidelines, which specifically addresses this topic. Option C provides t ct reference to the relevant section. Options A, B, and D are unrelate opic of pharmacokinetics and product metabolism in animals and can nated.

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    Question: 918


    Which of the following treatment assignments involves providing subjects with information about the treatment they are receiving?

    1. Randomization

    2. Double-blind

    3. Open label

    4. Registries Answer: C

    mation about the treatment they are receiving is an open-label assign open-label trial, both the subjects and the researchers are aware of th ment allocation. Options A, B, and D describe other treatment assign ods but do not involve disclosing treatment information to the subject efore, option C is the correct answer.


    stion: 919


    ch of the following study design characteristics involves assigning sub fferent treatment groups randomly?


    ouble-blind rossover andomized pen label


    wer: C

    Explanation: The treatment assignment that involves providing subjects with infor ment.

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    2. C

    3. R

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    Explanation: The study design characteristic that involves assigning subjects to different treatment groups randomly is a randomized design. Randomization helps minimize bias and ensure that the treatment groups are comparable, which is important for drawing valid conclusions from the study. Options A, B, and D describe other study design characteristics, but they do not specifically involve random assignment. Therefore, option C is the correct answer.

    Question: 920


    What is the primary purpose of an Investigational Brochure (IB) or investigational device usedocumentation?


    1. To provide detailed instructions for using the investigational product or device

      linical trial

      facilitate communication between the sponsor and the regulatory orities

      provide comprehensive information about the investigational produ ce to investigators and study staff


      wer: D


      anation: The primary purpose of an Investigational Brochure (IB) or stigational device use documentation is to provide comprehensive mation about the investigational product or device to investigators an

      staff. The IB contains detailed information about the product's acteristics, pharmacokinetics, and safety profiles, among other import ls. Options A, B, and C may be secondary purposes of the IB, but the he primary purpose described in this question. Therefore, option D is ct answer.

      To inform subjects about the potential risks and benefits of participating in the c

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