LATEST ACRP ACRP-CP EXAM PRACTICE & NEW ACRP-CP TEST REVIEW

Latest ACRP ACRP-CP Exam Practice & New ACRP-CP Test Review

Latest ACRP ACRP-CP Exam Practice & New ACRP-CP Test Review

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Tags: Latest ACRP-CP Exam Practice, New ACRP-CP Test Review, ACRP-CP Exam Vce, ACRP-CP Download Pdf, ACRP-CP Exam Fee

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ACRP Certified Professional Exam Sample Questions (Q16-Q21):

NEW QUESTION # 16
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

  • A. The frequency of data backup 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 number of users with access was not defined.

Answer: A

Explanation:
The frequency of data backup is a critical element of an Electronic Data Capture (EDC) system's Standard Operating Procedure (SOP). Ensuring regular and systematic data backup is essential for protecting trial data against loss or corruption. Failure to specify backup frequency indicates a gap in data security management.
GCP guidelines stress that data protection, including regular backups, is essential to maintaining data integrity in clinical trials.
"EDC system SOPs must include clear guidelines on data backup frequency to safeguard the integrity and availability of study data." Objectives:
* Ensure data security through regular backups.
* Maintain data integrity in clinical research.


NEW QUESTION # 17
Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

  • A. Notify the sponsor.
  • B. Call the participant to return for an unscheduled visit.
  • C. Report a protocol deviation to the IRB/IEC.
  • D. Notify the PI.

Answer: D

Explanation:
The CRC's first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant's medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.
According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.
"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making." Objectives:
* Ensure rapid response to dosing errors.
* Maintain participant safety as a priority.


NEW QUESTION # 18
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

  • A. IRB/IEC
  • B. CRO
  • C. Sponsor
  • D. Investigator

Answer: C

Explanation:
The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions before the trial begins. This includes outlining roles and responsibilities in collaboration with investigators, CROs, and other stakeholders. Proper delegation ensures the trial is conducted according to protocol and regulatory requirements.
This answer is verified based on GCP guidelines, which clearly state that sponsors are responsible for the organization and management of trial-related tasks.
"The sponsor is responsible for allocating duties and functions related to the conduct of the trial, ensuring compliance with regulatory and ethical standards." Objectives:
* Clarify the sponsor's role in clinical trial management
* Define responsibilities in trial planning


NEW QUESTION # 19
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

  • A. Recording data on source documents at the time the data are collected during the conduct of the study.
  • B. Comparing source document data to other data recorded in the same study time period.
  • C. Allowing real-time access for data review in the eCRF.
  • D. Recording the date and time each data element is entered onto the source document.

Answer: A

Explanation:
Contemporaneous data means that data entries are made at the time of the event or as soon as possible after the event occurs. This practice ensures that the recorded data accurately reflect the participant's condition and study procedures, minimizing recall bias and errors. Maintaining contemporaneous records is a fundamental requirement for ensuring the accuracy and reliability of clinical trial data.
GCP guidelines specify that data should be recorded as close to the time of the event as possible to ensure accuracy and reliability.
"Data must be contemporaneously recorded, meaning they are documented at the time of the occurrence to accurately reflect the study conduct." Objectives:
* Ensure accurate and real-time data capture.
* Maintain data integrity by minimizing recall bias.


NEW QUESTION # 20
A study protocol must contain which of the following elements?

  • A. Description of statistical methods
  • B. Participant reimbursement details
  • C. Data management plan
  • D. Chemical structure of the IP

Answer: A

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.


NEW QUESTION # 21
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