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Latest ACRP-CP Exam Duration - Exam ACRP-CP Study Solutions

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ACRP Certified Professional Exam Sample Questions (Q26-Q31):

NEW QUESTION # 26
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Draft a CAPA plan
B. Establish a DSMB/IDMC
C. Develop a monitoring plan
D. Conduct routine investigators' meetings

Answer: B

Explanation:
A Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) is established to review ongoing trial data at regular intervals. The DSMB evaluates safety, progress, and efficacy endpoints and makes recommendations to continue, modify, or terminate the study based on interim data. This independent oversight helps ensure participant safety and data integrity throughout the trial.
GCP guidelines recommend forming a DSMB for studies that involve high risks or long durations, ensuring continuous safety monitoring.
"The DSMB is responsible for the periodic review of accumulating data and providing recommendations regarding trial continuation, modification, or termination." Objectives:
* Ensure ongoing safety evaluation.
* Facilitate objective decisions on trial continuation.

NEW QUESTION # 27
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A. Factorial
B. Group sequential
C. Parallel Group
D. Crossover

Answer: D

Explanation:
A crossover study design involves participants receiving multiple interventions sequentially, with a washout period in between to minimize carryover effects. This design allows each participant to serve as their own control, increasing statistical power while reducing variability. It is commonly used when comparing two treatments or interventions.
GCP guidelines classify a crossover design as one where subjects receive multiple treatments in a specified sequence.
"In crossover trials, participants receive each intervention in a specific order, allowing for within-subject comparison." Objectives:
* Understand the structure of crossover studies.
* Improve statistical efficiency through self-control comparisons.

NEW QUESTION # 28
A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A. 77%
B. 80%
C. 66%
D. 71%

Answer: A

Explanation:
Step 1:Calculate the total number of tablets dispensed:
* Month 1: 35 tablets
* Month 2: 35 tablets
* Total: 70 tablets
Step 2:Calculate the number of tablets returned:
* Month 1: 10 tablets
* Month 2: 12 tablets
* Total: 22 tablets
Step 3:Calculate the number of tablets taken:
* 70 - 22 = 48 tablets
Step 4:Calculate compliance:
* Compliance = (Tablets Taken / Total Tablets) × 100
* Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count." Objectives:
* Monitor compliance with IP administration.
* Ensure accurate calculation of adherence rates.

NEW QUESTION # 29
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A. PI
B. CRC
C. Sponsor
D. CRA

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for providing access to study documentation during an audit or inspection. This includes regulatory files, participant records, and study logs. The PI ensures that auditors and inspectors have appropriate access while maintaining the confidentiality of subject data.
GCP guidelines clearly assign the responsibility for maintaining and granting access to trial documentation to the PI at the study site.
"The PI is responsible for ensuring that study-related documents are available for review during audits or inspections." Objectives:
* Maintain transparency during inspections.
* Ensure compliance with documentation requirements.

NEW QUESTION # 30
When designing a clinical trial, why is it important to define the study population?

A. To determine the study objectives
B. To determine where to conduct the study
C. To support the study objectives
D. To support subject recruitment to the study

Answer: C

Explanation:
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.

NEW QUESTION # 31
......

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