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ACRP Certified Professional Exam Sample Questions (Q97-Q102):

NEW QUESTION # 97
The composition of an IDMC/DSMB should include which one of the following?

A. A member from the IRB/IEC
B. A sponsor representative who is knowledgeable about the study's unblinded information
C. A clinical scientist who is knowledgeable in the appropriate discipline
D. A lead PI for the study

Answer: C

Explanation:
An Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) should include clinical scientists who are knowledgeable in the relevant medical and scientific areas. Their role is to objectively assess the ongoing safety data and efficacy of the investigational product, ensuring that participants' safety is not compromised.
GCP guidelines emphasize the need for experienced clinical scientists on IDMC/DSMBs to ensure that safety data is interpreted accurately and professionally.
"IDMC/DSMB should comprise independent experts, including clinical scientists, who have the expertise to evaluate safety and efficacy data objectively." Objectives:
* Ensure impartial evaluation of safety data.
* Maintain scientific integrity in monitoring clinical trials.

NEW QUESTION # 98
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

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

Answer: B

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 # 99
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A. Update the IB to add the risk of infection and submit to the sponsor for approval.
B. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
C. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
D. Add the risk of infection to the ICF and submit to the IRB/IEC for review.

Answer: B

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.

NEW QUESTION # 100
IP is dispensed to all subjects who:

A. Are eligible to receive it in the trial.
B. Screened for the trial.
C. Need IP for their medical condition.
D. Consented for the trial.

Answer: A

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 101
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

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

Answer: B

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 # 102
......

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