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ACRP Certified Professional Exam Sample Questions (Q30-Q35):

NEW QUESTION # 30
After the completion or termination of a clinical trial, who should store the enrollment log?

A. Sponsor
B. Regulatory authority
C. PI
D. CRO

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for maintaining and securely storing essential documents, including the enrollment log, after the completion or termination of a clinical trial. This ensures that all participant-related records are retained for audit or inspection as per regulatory requirements.
This answer is consistent with GCP guidelines, which specify that the PI is accountable for retaining essential trial documents at the study site.
"The investigator should maintain records of trial participants, including the enrollment log, as part of the essential documents for trial conduct." Objectives:
* Maintain data integrity and compliance with record-keeping requirements.
* Ensure secure and accessible storage of participant information.

NEW QUESTION # 31
An impartial witness should be present during the entire informed consent discussion when:

A. A parent/guardian is consenting for a minor subject.
B. A subject has been determined to be vulnerable.
C. An interpreter is translating the consent form for a subject.
D. A legally acceptable representative is unable to read.

Answer: D

Explanation:
An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.
GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.
"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound." Objectives:
* Protect the rights of individuals with literacy challenges.
* Maintain ethical standards in the consent process.

NEW QUESTION # 32
While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that any laboratory used for trial-related testing is appropriately qualified and certified. This includes verifying the laboratory's accreditation, quality control procedures, and ability to perform the required tests accurately. The PI must document the qualification process to ensure compliance with GCP and protocol requirements.
GCP guidelines state that the investigator is responsible for selecting and verifying the qualification of laboratories used in the study.
"The PI must ensure that any laboratory involved in the trial is properly qualified and capable of performing the specified tests according to protocol requirements." Objectives:
* Maintain quality control in laboratory testing.
* Ensure the accuracy and reliability of test results.

NEW QUESTION # 33
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. 66%
B. 77%
C. 71%
D. 80%

Answer: B

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 # 34
Who must be blinded in a double-blind study in order to prevent bias?

A. Data entry staff
B. Pharmacist
C. Subject
D. IRB/IEC

Answer: C

Explanation:
In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment.
Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.
According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.
"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias." Objectives:
* Maintain the integrity of the study by preventing bias.
* Enhance the validity of trial outcomes.

NEW QUESTION # 35
......

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