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ACRP-CP Valid Dump | New ACRP-CP Exam Duration

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ACRP Certified Professional Exam Sample Questions (Q71-Q76):

NEW QUESTION # 71
IP is dispensed to all subjects who:

A. Screened for the trial.
B. Need IP for their medical condition.
C. Consented for the trial.
D. Are eligible to receive it in the trial.

Answer: D

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 72
The IB contains which of the following sections?

A. IP preparation instructions
B. Participant dosing schedule
C. Participant eligibility criteria
D. Known pharmacokinetic effects

Answer: D

Explanation:
The Investigator's Brochure (IB) contains comprehensive information about the investigational product (IP), including its pharmacokinetic and pharmacodynamic properties, preclinical and clinical trial data, and any known side effects. The IB provides a scientific basis for the study protocol and helps investigators understand the potential risks and benefits.
GCP guidelines state that the IB must include relevant scientific data, including pharmacokinetic and pharmacodynamic profiles.
"The IB should provide data on the pharmacokinetics and pharmacodynamics of the investigational product to inform clinical practice." Objectives:
* Provide comprehensive data on investigational products.
* Support safe and informed clinical decision-making.

NEW QUESTION # 73
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:

A. Verify compliance with IP regimen.
B. Evaluate study data.
C. Conduct safety analysis.
D. Validate protocol endpoints.

Answer: A

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.

NEW QUESTION # 74
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. PI
B. Sponsor
C. Subject
D. CRO

Answer: B

Explanation:
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.

NEW QUESTION # 75
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?

A. Attributable
B. Complete
C. Contemporaneous
D. Original

Answer: B

Explanation:
The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study's outcomes.
GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.
"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity." Objectives:
* Ensure comprehensive data recording.
* Maintain accuracy and completeness in study records.

NEW QUESTION # 76
......

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