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

NEW QUESTION # 49
A serious unexpected ADR is one:

A. That results in the death of the subject.
B. That does not need to be reported to the IRB/IEC.
C. Severity and nature of the reaction is consistent with protocol.
D. Where the severity of the reaction is not consistent with IB.

Answer: D

Explanation:
A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator's Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.
This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.
"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)." Objectives:
* Understanding classification of ADRs
* Ensuring timely and accurate reporting of unexpected events

NEW QUESTION # 50
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

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

Answer: D

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 # 51
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A. Availability of qualified staff to conduct the trial
B. Length of time to receive the approved trial device
C. Information to be included in the advertising flyer
D. Location of stored trial records

Answer: A

Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial

NEW QUESTION # 52
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. CRO
B. PI
C. Subject
D. Sponsor

Answer: D

Explanation:
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.

NEW QUESTION # 53
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A. Verify compliance with IP regimen.
B. Validate protocol endpoints.
C. Conduct safety analysis.
D. Evaluate study data.

Answer: A

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.

NEW QUESTION # 54
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Prominent Features of DumpsMaterials ACRP ACRP-CP Practice Questions

ACRP - ACRP-CP Authoritative Reliable Exam Questions

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

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