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ACRP-CP Interactive Questions - Real ACRP-CP Exam

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ACRP Certified Professional Exam Sample Questions (Q60-Q65):

NEW QUESTION # 60
An impartial witness should be present during the entire informed consent discussion when:

A. A parent/guardian is consenting for a minor subject.
B. A legally acceptable representative is unable to read.
C. A subject has been determined to be vulnerable.
D. An interpreter is translating the consent form for a subject.

Answer: B

Explanation:
An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.
GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.
"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound." Objectives:
* Protect the rights of individuals with literacy challenges.
* Maintain ethical standards in the consent process.

NEW QUESTION # 61
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B. Training records of site personnel on study protocol, and their study-related duties and functions.
C. A monitoring report that identifies deviation from the approved protocol.
D. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Answer: B

NEW QUESTION # 62
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. As soon as the protocol amendment is submitted to the IRB/IEC
B. When the need for the additional data is discovered
C. After the original planned data collection is completed
D. After the protocol amendment is approved by the IRB/IEC

Answer: D

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 63
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. Contemporaneous
B. Original
C. Complete
D. Attributable

Answer: C

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 # 64
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?

A. 1.8 mg/dL
B. 3.0 mg/dL
C. 2.6 mg/dL
D. 3.6 mg/dL

Answer: B

Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.

NEW QUESTION # 65
......

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