ACRP-CCRC Dumps
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What is the rationale for complying with a protocol in a clinical trial?
To ensure accurate and reliable data collection
To minimize the number of subjects needed for the study
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.
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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Subject's willingness to comply with study procedures Answer: B
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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.
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.
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?
Study population demographics and characteristics
Informed consent process and documentation
Adverse event reporting procedures
Subject eligibility criteria
Answer: C
fically related to the IB or investigational device use documentation. efore, option C is the correct answer.
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.
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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Which of the following treatment assignments involves providing subjects with information about the treatment they are receiving?
Randomization
Double-blind
Open label
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.
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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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.
What is the primary purpose of an Investigational Brochure (IB) or investigational device usedocumentation?
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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