NEW ACRP-CP DUMPS EBOOK - HOT ACRP-CP EXAM CRAM PDF AND EFFECTIVE VALID ACRP CERTIFIED PROFESSIONAL EXAM LEARNING MATERIALS

New ACRP-CP Dumps Ebook - Hot ACRP-CP Exam Cram Pdf and Effective Valid ACRP Certified Professional Exam Learning Materials

New ACRP-CP Dumps Ebook - Hot ACRP-CP Exam Cram Pdf and Effective Valid ACRP Certified Professional Exam Learning Materials

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ACRP Certified Professional Exam Sample Questions (Q49-Q54):

NEW QUESTION # 49
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. When the need for the additional data is discovered
  • B. After the original planned data collection is completed
  • C. As soon as the protocol amendment is submitted to the IRB/IEC
  • 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 # 50
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

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

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 # 51
Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

  • A. How likely are patients at high risk of cancer going to develop cancer during the study?
  • B. How effective is the drug at treating patients that have been previously diagnosed with cancer?
  • C. How willing are current patients to participate in a trial with potentially serious side effects?
  • D. How does the risk of developing cancer compare to the anticipated side effects from the drug?

Answer: D

Explanation:
Before initiating a clinical trial with a drug that has potentially serious side effects, it is essential to evaluate the risk-benefit ratio. The primary consideration is whether the potential benefits (reduced cancer risk) outweigh the risks (serious side effects). This assessment is fundamental to ethical clinical trial design.
The answer is verified as per GCP and ethical guidelines, which require a thorough assessment of risk versus benefit before conducting human trials.
"An assessment of potential benefits versus risks is a fundamental principle in the ethical design of clinical trials, especially when potential adverse effects are severe." Objectives:
* Ensure ethical considerations in trial design.
* Assess the potential harm versus benefit to participants.


NEW QUESTION # 52
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

  • A. PI
  • B. Sponsor
  • C. Regulatory Agency
  • D. CRC

Answer: A

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.


NEW QUESTION # 53
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

  • A. 7 calendar days
  • B. 30 calendar days
  • C. 15 calendar days
  • D. 8 calendar days

Answer: C

Explanation:
The sponsor is required to report serious unexpected adverse events (SAEs) to the regulatory authorities within 15 calendar days from the date of awareness. This reporting period is mandated to ensure that any new safety information that may affect the risk/benefit profile of the investigational product (IP) is promptly communicated, thereby protecting participant safety.
GCP guidelines specify that serious, unexpected, and related AEs must be reported to regulatory authorities within 15 days of being known to the sponsor.
"Serious unexpected adverse reactions that may affect the safety profile of the IP must be reported within 15 calendar days to the regulatory authorities." Objectives:
* Ensure timely reporting of safety information.
* Protect the safety of trial participants.


NEW QUESTION # 54
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