ACRP-CP EXAM NEWEST TEST BANK 2 VERSION S

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ACRP-CP EXAM NEWEST TEST BANK| 2 VERSION S

(VERSION A & B) WITH 650 ACTUAL EXAM QUESTIONS AND

CORRECT DETAILED ANSWERS ( VERIFIED ANSWERS )

GRADED A+| ACRP-CP CERTIFICATION EXAM PREP

(BRAND NEW!!)

ACRP-CP EXAM VERSION A.

What are original documents, data and records about a subject in a clinical trial captured in?

• Case Report Forms
• Medical Records
• Source Documents
• Essential Documents - Correct Answer - c. Source Documents

Who determines the nature and extent of monitoring that should be performed for a given trial?

• The sponsor
• The CRO
• The Regulatory Authorities
• The IRB/IEC - Correct Answer - a. The sponsor

As part of a risk-based quality management approach, ICH GCP E6 (R2) guidelines recommend that all of the following be included as risk control measures EXCEPT what?

• That the sponsor determines which risks to accept or reduce 1 / 4

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• That pre-defined quality tolerance limits (QLTs) are established
• That quality tolerance limits (QLTs) are determined on an as needed

basis

• That deviations from QLTs should trigger an evaluation to determine

if further action is needed. - Correct Answer - c. That quality tolerance limits (QLTs) are determined on an as needed basis.

Which of the following is an influential document that led to the evolution of informed consent practices?

• The Nuremberg Code
• The Declaration of Helsinki
• The Belmont Report
• All of the above - Correct Answer - d. All of the above

According to GCPs, which of the following methods best ensure transparency and allow for the reconstruction of the course of events taking place in a clinical trial?

• Audit Trail
• Source Document Verification
• Trial Master Files
• Case Report Forms - Correct Answer - a. Audit Trail

What is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), GCP, and the applicable regulatory requirements known as? 2 / 4

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• Source data verification
• Auditing
• Monitoring
• Study coordinating
• Risk management and oversight - Correct Answer - c. Monitoring

A monitor (CRA) is reviewing source documents at an investigative site and finds blood pressure recorded for a subject visit in a photocopy of the medical records for the day of the subject's visit. Which of the source document ALCOA-C principles is in conflict in this scenario?

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• Complete - Correct Answer - d. Original

When a potential subject confuses the research study for a proven treatment, this is known as what?

• Therapeutic misconception
• Clinical equipoise
• The participant's dilemma
• The uncertainty principle - Correct Answer - a. Therapeutic

misconception

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pg. 4 How can data quality assurance be ensured?

• Training of study personnel
• Monitoring of investigators by sponsor/CRO personnel
• Instruction manuals
• Data verification
• Centralized testing (e.g., labs, ECG readings)
• All of the above - Correct Answer - f. All of the above

A planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants is called what?

• An outcome measure
• A primary objective
• A hypothesis
• None of the above - Correct Answer - 1. An outcome measure

The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).

• True
• False - a. True

All but which of the following have the authority to terminate a clinical trial for the entire study or at a given site?

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