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Title: ACRP-CP Dump File | Exam ACRP-CP Bible [Print This Page]
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Title: ACRP-CP Dump File | Exam ACRP-CP Bible
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ACRP Certified Professional Exam Sample Questions (Q121-Q126):NEW QUESTION # 121
Who is responsible for submitting a protocol amendment to the IRB/IEC?
Answer: D
Explanation:
The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.
According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.
"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation." Objectives:
* Maintain ethical oversight in study modifications.
* Adhere to regulatory submission requirements.

NEW QUESTION # 122
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?
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 # 123
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:
Answer: B
Explanation:
The purpose of statistical analysis in a clinical trial is to evaluate whether the data supports rejecting the null hypothesis, which typically states that there is no effect or difference. If the analysis finds a statistically significant result, the null hypothesis is rejected, indicating that the investigational drug has an effect on cholesterol levels.
The answer follows statistical principles in clinical trials, where the null hypothesis is rejected if evidence shows a significant difference or effect.
"In hypothesis testing, rejecting the null hypothesis indicates that the treatment effect is statistically significant." Objectives:
* Understand hypothesis testing in clinical research.
* Interpret statistical outcomes accurately.

NEW QUESTION # 124
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?
Answer: B
Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"articipants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.

NEW QUESTION # 125
The PI should ensure that source data is:
Answer: A
Explanation:
The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.
GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.
"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity." Objectives:
* Ensure accurate data transposition from source to CRF.
* Maintain high standards of data quality and reliability.

NEW QUESTION # 126
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