RELIABLE ACRP-CP BRAINDUMPS FREE | ACRP-CP RELIABLE EXAM TESTKING

Reliable ACRP-CP Braindumps Free | ACRP-CP Reliable Exam Testking

Reliable ACRP-CP Braindumps Free | ACRP-CP Reliable Exam Testking

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ACRP Certified Professional Exam Sample Questions (Q98-Q103):

NEW QUESTION # 98
The coding system for a double-blind clinical trial is accessible by the:

  • A. Sponsor
  • B. IRB/IEC
  • C. PI
  • D. Regulatory authority

Answer: A

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.


NEW QUESTION # 99
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. Complete
  • C. Attributable
  • 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 # 100
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

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

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 # 101
While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

  • A. CRO
  • B. Sponsor
  • C. CRC
  • D. PI

Answer: D

Explanation:
The Principal Investigator (PI) is responsible for ensuring that any laboratory used for trial-related testing is appropriately qualified and certified. This includes verifying the laboratory's accreditation, quality control procedures, and ability to perform the required tests accurately. The PI must document the qualification process to ensure compliance with GCP and protocol requirements.
GCP guidelines state that the investigator is responsible for selecting and verifying the qualification of laboratories used in the study.
"The PI must ensure that any laboratory involved in the trial is properly qualified and capable of performing the specified tests according to protocol requirements." Objectives:
* Maintain quality control in laboratory testing.
* Ensure the accuracy and reliability of test results.


NEW QUESTION # 102
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

  • A. Standard Operating Procedure
  • B. Investigator's Brochure
  • C. Data & Safety Monitoring Plan
  • D. Clinical Monitoring Plan

Answer: A

Explanation:
The Standard Operating Procedure (SOP) outlines the process for shipping, storing, mixing, and transferring the investigational product (IP) between locations. SOPs ensure that all steps are consistently followed and documented, maintaining the integrity and quality of the IP throughout the handling process. This is critical for maintaining compliance with Good Clinical Practice (GCP) and ensuring patient safety.
GCP guidelines specify that SOPs should cover the handling, transfer, and storage of investigational products to ensure quality control.
"SOPs provide detailed guidance on the handling and transfer of investigational products to ensure consistency and compliance." Objectives:
* Maintain the integrity of IP during transport and handling.
* Ensure compliance through standardized procedures.


NEW QUESTION # 103
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